Viral infections Archives - MPR

AACR: At-Home HPV Testing Boosts Cervical Cancer Screening Participation

Haymarket Media — Mon, 15 Apr 2024 13:00:00 +0000

HealthDay News — Mailed at-home self-sampling for human papillomavirus (HPV) testing increases cervical cancer screening participation in underscreened populations by almost threefold, according to a study presented at the annual meeting of the American Association for Cancer Research, held from April 5 to 10 in San Diego.

Jane R. Montealegre, PhD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the effectiveness of mailed at-home self-sampling for HPV testing in a safety-net health system setting. The analysis included data from 2115 patients who were randomly assigned to one of the 3 following arms: telephone recall to provider-performed screening (usual care; arm 1); telephone recall + mailed self-sampling kit for HPV testing (arm 2); or telephone recall + mailed self-sampling kit + telephone-based patient navigation (arm 3).

The researchers found that among participants, the median time since last screening test was 9.5 years. Screening participation across arms 1, 2, and 3 was 15.3, 44.0, and 51.4%, respectively. Compared with usual care (arm 1), the relative incidence of screening in arms 2 and 3 was 2.90 and 3.36, respectively. For arm 3 vs arm 2, the relative incidence of screening was 1.16.

“After US Food and Drug Administration approval, self-sampling for high-risk-HPV testing has the potential to dramatically increase participation in cervical cancer screening in underserved populations,” the authors write.

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Abacavir

Haymarket Media — Mon, 29 Jan 2024 21:52:31 +0000

Abacavir (as sulfate) 300mg; scored tabs.

Abacavir/Lamivudine

Haymarket Media — Thu, 25 Jan 2024 13:24:56 +0000

Abacavir (as sulfate) 600mg, lamivudine 300mg; tabs.

About 100,000 US Nurses Left Workforce During Pandemic

Haymarket Media — Fri, 14 Apr 2023 13:00:00 +0000

HealthDay News — During the pandemic, nearly 100,000 US registered nurses called it quits, a new survey shows. A combination of stress, burnout, and retirements created a perfect storm for the exodus.

Even worse, another 610,000 registered nurses (RNs) said they had an “intent to leave” the workforce by 2027, citing those same reasons. And an additional 189,000 RNs younger than 40 years reported similar intentions, the study from the National Council of State Boards of Nursing (NCSBN) revealed. Put together, this means about one-fifth of the 4.5 million registered nurses nationally could leave the health care workforce in a short time period.

“The data is clear: the future of nursing and of the US health care ecosystem is at an urgent crossroads,” Maryann Alexander, chief officer of nursing regulation at the NCSBN, said in a council news release. “The pandemic has stressed nurses to leave the workforce and has expedited an intent to leave in the near future, which will become a greater crisis and threaten patient populations if solutions are not enacted immediately.”

The survey laid bare the pandemic’s impact on nursing, and examined the personal and professional characteristics of nurses experiencing heightened workplace burnout and stress due to the pandemic.

Data were gathered as part of a biennial nursing workforce study conducted by NCSBN and the National Forum of State Nursing Workforce Centers. Among the findings: 62% of nurses sampled said they had an increase in workload during the pandemic; nearly 51% said they felt emotionally drained; and 56% said they felt used up. About 50% of nurses reported being fatigued; 45% said they were burned out; and 29% were at the end of their rope “a few times a week” or “every day.”

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These concerns were most pronounced in nurses with 10 or fewer years of experience, according to the report. This drove an overall 3.3% decline in the US nursing workforce in the past two years. Meanwhile, the number of licensed practical/vocational nurses, who generally work in long-term care settings, declined by nearly 34,000 since the beginning of the pandemic.

Pandemic disruptions in nursing programs have also raised concerns about the supply and clinical preparedness of new nurse graduates. Early career data for these new nurses suggest decreased practice and assessment proficiency, according to the researchers.

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ACC: COVID-19 Vaccination Cuts Risk for Cardiac Events With SARS-CoV-2 Infection

Haymarket Media — Tue, 07 Mar 2023 14:00:00 +0000

HealthDay News — Partial or complete COVID-19 vaccination is associated with a lower risk for major adverse cardiac events (MACE) after SARS-CoV-2 infection, according to a research letter published in the March 7 issue of the Journal of the American College of Cardiology to coincide with the annual meeting of the American College of Cardiology, held from March 4 to 6 in New Orleans.

Joy Jiang, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues examined the association between vaccination and MACE among patients with prior SARS-CoV-2 infection. The analysis included 1.93 million patients identified from the National COVID Cohort Collaborative.

The researchers found that of the 13,948 patients experiencing MACE, most events occurred in the 12,733 nonvaccinated patients, while 160 events occurred in partially vaccinated patients and 1055 occurred in fully vaccinated patients. The median time to MACE from index infection was 17 days. Comorbidities significantly differed in patients with and without MACE, including previous MACE (29.1 vs 0.9%), type 2 diabetes (33.9 vs 7.5%), hyperlipidemia (50.7 vs 14.4%), ischemic heart disease (40.6 vs 3.9%), liver disease (4.0 vs 0.8%), and obesity (29.4 vs 16.4%). Full (adjusted hazard ratio, 0.59) and partial vaccination (adjusted hazard ratio, 0.76) were associated with a reduced risk for MACE. Male sex, age (notably 66 years and older), and comorbidities (notably previous MACE) were associated with a significantly increased risk for MACE.

“To our surprise, even partial vaccination was associated with lower risk of adverse cardiovascular events,” Jiang said in a statement. “Given the magnitude of SARS-CoV-2 infection worldwide, we hope our findings could help improve vaccination rates, especially in individuals with coexisting conditions.”

Several authors disclosed financial ties to the biopharmaceutical industry.

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ACIP Votes for Routine Use of Jynneos in Adults at Risk of Mpox Infection

Steve Duffy — Tue, 05 Dec 2023 16:15:00 +0000

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted in favor of routine use of Jynneos^® (smallpox and monkeypox vaccine, live, nonreplicating) for the prevention of mpox disease in adults 18 years of age and older determined to be at high risk for mpox infection. Previously, the ACIP had recommended the vaccine for use only during an outbreak.

Originally approved in 2019, Jynneos was developed in collaboration with the US government to ensure a supply of a smallpox vaccine for the entire population. During the mpox outbreak in 2022, the US Department of Health and Human Services (HHS) expanded access to Jynneos to mitigate the spread of the infection, while the Food and Drug Administration (FDA) granted emergency use authorization for intradermal injection in individuals 18 years of age and older and subcutaneous injection in those younger than 18 years of age who were determined to be at high risk.

“Since the outbreak of mpox last year, Bavarian Nordic has supplied millions of doses of our vaccine to more than 70 countries worldwide, which has had a positive impact on controlling this unprecedented outbreak of mpox,” said Paul Chaplin, President and CEO of Bavarian Nordic. “The broadened ACIP recommendation recognizes the significance of maintaining a high awareness of the disease among risk groups and the importance of ensuring broader access to the vaccine beyond an outbreak situation.”

The recommendation has been adopted by the Director of the CDC and is now included in the 2024 adult immunization schedule. Bavarian Nordic intends to launch Jynneos in the US in the first half of 2024.

“Entering the private mpox vaccine market in the US offers an opportunity to provide improved access to Jynneos and to build a steady commercial business segment, complimenting the existing smallpox stockpiling business with the US government,” added Chaplin.

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Jynneos is administered by subcutaneous injection as 2 doses (0.5mL each) 4 weeks apart. Each vial contains a single dose (0.5mL).

Last Reviewed: December 5, 2023

ACIP: Updated Vaccine Guidance for the 2023-2024 Influenza Season

Steve Duffy — Thu, 24 Aug 2023 15:45:00 +0000

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices has issued new guidelines for the prevention and control of seasonal influenza with vaccines for the 2023-2024 season. Routine annual influenza vaccination is recommended for all patients 6 months of age and older who have no contraindications. Vaccination should ideally be completed by October though it should be offered throughout the season if influenza viruses continue to circulate.

For the 2023–2024 season, all influenza vaccines are expected to be quadrivalent, containing hemagglutinin (HA) derived from one influenza A(H1N1)pdm09 virus, one influenza A(H3N2) virus, one influenza B/Victoria lineage virus, and one influenza B/Yamagata lineage virus.

Egg-based influenza vaccines:

Will contain HA derived from an influenza A/Victoria/4897/2022 (H1N1)pdm09-like virus, an influenza A/Darwin/9/2021 (H3N2)-like virus, an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus, and an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus.
These include Afluria Quadrivalent, Fluarix Quadrivalent, FluLaval Quadrivalent, Fluzone Quadrivalent (all standard dose), Fluzone High-Dose Quadrivalent (high-dose formulation), Fluad Quadrivalent (standard dose with MF59 adjuvant), and FluMist Quadrivalent intranasal spray.

Cell culture-based inactivated or recombinant influenza vaccines:

Will contain HA derived from an influenza A/Wisconsin/67/2022 (H1N1)pdm09-like virus, an influenza A/Darwin/6/2021 (H3N2)-like virus, an influenza B/Austria/1359417/2021 (Victoria lineage)-like virus, and an influenza B/Phuket/3073/2013 (Yamagata lineage)-like virus.
These include Flucelvax Quadrivalent (standard dose cell culture-based) and Flublok Quadrivalent (recombinant).

Updates to the guidance for this upcoming influenza season include the following:

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ACIP recommends all persons 6 months of age and older with egg allergy receive influenza vaccine (egg-based or nonegg-based) that is otherwise appropriate for the recipient’s age and health status.
- It is no longer recommended that individuals who have had an allergic reaction to egg with symptoms other than urticaria should be vaccinated in a medical setting supervised by a health care provider who is able to recognize and manage severe allergic reactions if an egg-based vaccine is used.
- Egg allergy alone does not require additional safety measures for influenza vaccination beyond those recommended for any recipient of any vaccine, regardless of severity of previous reaction to egg.
- All vaccines should be administered in settings in which personnel and equipment needed for rapid recognition and treatment of acute hypersensitivity reactions are available.
- Additional information about this recommendation can be found here.

Regarding simultaneous administration of influenza vaccine with the new respiratory syncytial virus (RSV]) vaccine, data included in the prescribing information for GSK’s Arexvy show no evidence for interference in the immune response to any of the antigens contained in both concomitantly administered vaccines. In this study (ClinicalTrials.gov Identifier: NCT04841577), participants 60 year of age and older received 1 dose of Arexvy and Fluarix Quadrivalent. The criteria for noninferiority of the immune responses in the control vs coadministration group were met, though RSV and influenza antibody titers were somewhat lower with coadministration; the clinical significance of this is unknown.

The full report, which includes guidance for influenza vaccination of specific populations (eg, children, pregnant people, older patients, immunocompromised individuals), and situations (eg, history of Guillain-Barré Syndrome) can be found here.

ACTEMRA

Haymarket Media — Tue, 03 Jan 2023 20:18:12 +0000

Tocilizumab 20mg/mL (vial); soln for IV infusion after dilution; 162mg/0.9mL (prefilled syringe, autoinjector); soln for SC inj; both: preservative-free.

Acyclovir

Haymarket Media — Thu, 22 Jul 2021 10:45:51 +0000

Acyclovir 200mg; caps.

Acyclovir Inj

Haymarket Media — Thu, 22 Jul 2021 11:03:54 +0000

Acyclovir (as sodium) 500mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; contains sodium 49mg/vial.

Acyclovir Tablets

Haymarket Media — Thu, 22 Jul 2021 10:45:52 +0000

Acyclovir 400mg, 800mg.

Ad26.RSV.preF-RSV preF Protein Vaccine Immunogenic in Seniors

Haymarket Media — Thu, 16 Feb 2023 14:00:00 +0000

HealthDay News — An adenovirus serotype 26 respiratory syncytial virus (RSV) vector encoding a prefusion F (preF) protein (Ad26.RSV.preF) in combination with RSV preF protein is immunogenic and prevents RSV-mediated lower respiratory tract disease in older adults, according to a study published in the February 16 issue of the New England Journal of Medicine.

Ann R. Falsey, MD, from the University of Rochester School of Medicine in New York, and colleagues conducted a phase 2b, proof-of-concept trial to examine the efficacy, immunogenicity, and safety of Ad26.RSV.preF-RSV preF protein vaccine among adults aged 65 years or older. A total of 5782 participants were randomly assigned to receive vaccine or placebo in a 1:1 ratio. The primary end point was the first occurrence of RSV-mediated lower respiratory tract disease that met one of three case definitions.

The researchers found that RSV-mediated lower respiratory tract disease meeting case definitions 1, 2, and 3 occurred in six, 10, and 13 and in 30, 40, and 43 vaccine and placebo recipients, respectively. For case definitions 1, 2, and 3, vaccine efficacy was 80.0, 75.0, and 69.8%, respectively. From baseline to day 15 after vaccination, RSV A2 neutralizing antibody titers increased by a factor of 12.1. Compared with the placebo group, the percentages of participants with solicited local and systemic adverse events were higher in the vaccine group (local: 37.9 vs 8.4%; systemic: 41.4 vs 16.4%); most adverse events were mild to moderate. The frequency of serious adverse events was similar between the groups.

“Vaccine efficacy, immunogenicity, and safety were maintained across subgroups defined according to age and the presence of additional risk factors for severe RSV-mediated disease,” the authors write.

The study was funded by Janssen Vaccines and Prevention, which manufactures the Ad26.RSV.preF-RSV preF vaccine.

Advantaged Households Have Lower Intent to Vaccinate Teens Against HPV

Haymarket Media — Mon, 04 Mar 2024 14:00:00 +0000

HealthDay News — A significant proportion of adolescents who are unvaccinated or not fully vaccinated against human papillomavirus (HPV) are from advantaged socioeconomic households, according to a study published online February 19 in The Lancet Regional Health: Americas.

Kalyani Sonawane, from the Medical University of South Carolina in Charleston, and colleagues compared the factors associated with parental HPV vaccination intentions between socioeconomically divergent groups. The analysis included data from 212,643 adolescents (105,958 unvaccinated or not fully vaccinated) participating in the 2017 to 2021 National Immunization Survey-Teen.

The researchers found that in the advantaged group, 64.7% of parents of unvaccinated adolescents (equating to 2.4 million US adolescents) had no intention to initiate the HPV vaccine vs 40.9% of parents in the deprived group (equating to 0.2 million adolescents). In the advantaged group, the most frequent reason for lacking intent was “safety concerns” (25.5%), whereas in the deprived group, “lack of knowledge,” “not recommended,” and “not needed” were common reasons (nearly 15% each). The advantaged group had a higher lack of intent to complete the HPV vaccine series (43.9%; 1.1 million adolescents) versus the deprived group (25.2%; 0.08 million adolescents). More than half in the advantaged group (58.4%) and more than one-third in the deprived group (37.1%) cited “already up to date” as the primary reason for not completing the HPV vaccine series.

“Interventions that provide facts on vaccine safety and effectiveness and debunk HPV vaccine myths at an individual- and/or community-level, along with strong recommendations by health care providers, will be necessary to avoid stagnation of HPV vaccine rates and to continue making progress towards achieving the 80% national goal,” the authors write.

One author disclosed ties to Merck.

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Adverse Postoperative Outcomes Not Increased With Recent COVID-19

Haymarket Media — Wed, 29 Mar 2023 13:49:00 +0000

HealthDay News — Recent COVID-19 infection seems not to be associated with the risk for adverse postoperative outcomes, according to a research letter published online March 28 in JAMA Network Open.

William J. O’Brien, from the Center for Healthcare Organization and Implementation Research at Veterans Affairs Boston, and colleagues examined the risk for adverse postoperative outcomes among patients with recent infection, emulating a trial conducted in a large veteran population. A total of 29,093 patients (mean age, 66.1 years) underwent surgery at 123 hospitals from January 1 to September 30, 2021.

The researchers noted there was a median of 30 days between infection and surgery. Overall, 4.7% of the 28,635 patients without COVID-19 had adverse postoperative outcomes compared with 7.6 and 3.2% within the group with a one- to 30-day infection and the group with a 31- to 60-day infection, respectively. Among those with infection during preoperative days 1 to 30 and 31 to 60, the odds ratios for any adverse postoperative outcomes, including 30-day mortality, cardiac outcomes, central nervous system outcomes, respiratory outcomes, infection disease outcomes, or thromboembolic outcomes, were 1.40 (95% CI, 0.77 to 2.35) and 0.68 (95% CI, 0.26 to 1.42), respectively.

“Current evidence suggests the decision to proceed should be based on clinical expertise rather than a fixed time interval after infection, consistent with current guidelines,” the authors write.

One author disclosed financial ties to the pharmaceutical industry.

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AI Model Can Predict Mortality in Community-Acquired Pneumonia

Haymarket Media — Fri, 23 Jun 2023 13:44:04 +0000

HealthDay News — For patients with community-acquired pneumonia (CAP), a deep learning (DL) model using initial chest radiographs can predict 30-day mortality, according to a study published online June 14 in the American Journal of Roentgenology.

Changi Kim, from Seoul National University Hospital in South Korea, and colleagues developed a DL model to predict 30-day mortality in patients with CAP using chest radiographs from the time of diagnosis from 7105 patients from one institution. The model was evaluated in patients diagnosed with CAP during emergency department visits from the same institution (temporal test model [947 patients]) and from 2 additional different institutions (external test cohorts A and B [467 and 381 patients, respectively]).

The researchers found that in the temporal test set, the area under the receiver operating characteristic curve (AUC) for predicting 30-day mortality was higher for the DL model than the established risk prediction CURB-65 score (0.77 vs 0.67, respectively); in external test cohorts A and B, the higher AUC for the DL model was not significant compared with CURB-65 (0.80 vs 0.73 and 0.80 versus 0.72, respectively). In the 3 cohorts, the DL model exhibited significantly higher specificity (range, 61 to 69 vs 44 to 58%, respectively) at the same sensitivity achieved by the CURB-65 score. Compared with the CURB-65 score, combination of the DL model and CURB-65 score yielded an increase in AUC in the temporal test cohort and external test cohort B (0.77 and 0.80, respectively).

“The DL model may guide clinical decision-making in the management of patients with CAP by identifying high-risk patients who warrant hospitalization and intensive treatment,” the authors write.

Two authors disclosed financial ties to Lunit.

Alcohol Use Not Tied to Sustained Virologic Response With Hepatitis C Treatment

Haymarket Media — Tue, 03 Oct 2023 12:38:03 +0000

(HealthDay News) — Alcohol use is not associated with lower odds of sustained virologic response (SVR) among patients initiating direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection, according to a study published online Sept 26 in JAMA Network Open.

Emily J. Cartwright, MD, from the Atlanta Veterans Affairs Medical Center, and colleagues evaluated whether alcohol use at DAA treatment initiation is associated with a decreased likelihood of SVR. The analysis included 69,229 patients with chronic HCV infection who initiated DAA therapy between Jan 1, 2014, and June 30, 2018.

The researchers found that 94.4% of patients achieved SVR. Overall, 46.6% of participants were abstinent without alcohol use disorder (AUD), 13.3% were abstinent with AUD, 19.4% had lower-risk consumption, 4.5% had moderate-risk consumption, and 16.2% had high-risk consumption or AUD.

There was no difference in SVR across alcohol use categories, even for patients with high-risk consumption or AUD when adjusting for other confounders (odds ratio, 0.95; 95% CI, 0.85-1.07). Furthermore, there was no interaction by stage of hepatic fibrosis measured by fibrosis-4 score.

“These findings suggest that restricting access to DAA therapy on the basis of alcohol use creates an unnecessary barrier for patients and challenges HCV elimination goals,” the authors write.

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One author disclosed ties to the pharmaceutical industry.

Abstract/Full Text

Almost All Blood Donors Had SARS-CoV-2 Antibodies by Third Quarter of 2022

Haymarket Media — Fri, 09 Jun 2023 13:00:00 +0000

HealthDay News — Almost all blood donors had severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 antibodies from previous infection or vaccination by the third quarter of 2022, with the prevalence of hybrid immunity lowest for adults aged 65 years and older, according to research published in the June 2 issue of the US Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report.

Jefferson M. Jones, MD, from the CDC in Atlanta, and colleagues estimated the incidence of infection and prevalence of infection- or vaccination-induced SARS-CoV-2 antibodies using data from a nationwide, longitudinal cohort of blood donors.

The researchers found that an estimated 68.4% of persons aged 16 years and older had infection- or vaccination-induced SARS-CoV-2 antibodies during the second quarter of 2021, including 47.5, 12.0, and 8.9% from vaccination alone, infection alone, and both, respectively. Overall, 96.4% had SARS-CoV-2 antibodies by the third quarter of 2022, including 22.6, 26.1, and 47.7% from infection alone, vaccination alone, and hybrid immunity, respectively. Adults aged 65 years and older had the lowest prevalence of hybrid immunity (36.9%), and they had the highest risk for severe disease if infected; the prevalence of hybrid immunity was highest among those aged 16 to 29 years (59.6%).

“Compared with vaccine effectiveness against any infection and against severe disease or hospitalization, the effectiveness of hybrid immunity against these outcomes has been shown to be higher and wane more slowly,” the authors write.

Abstract/Full Text

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Amantadine

Haymarket Media — Thu, 22 Jul 2021 11:27:07 +0000

Amantadine HCl 100mg; tabs.

Amantadine Syrup

Haymarket Media — Thu, 22 Jul 2021 11:27:08 +0000

Amantadine HCl 50mg/5mL; raspberry flavor.

Amazon to Test Drones to Deliver Prescriptions Directly to Patient Homes

Haymarket Media — Fri, 20 Oct 2023 13:20:00 +0000

HealthDay News — Amazon announced Wednesday that it has started to test drone deliveries of prescription medications, delivering drugs to consumers’ doorsteps within an hour.

“We’re taught from the first days of medical school that there is a golden window that matters in clinical medicine,” Vin Gupta, MD, chief medical officer of Amazon Pharmacy, said in a company news release. “That’s the time between when a patient feels unwell and when they’re able to get treatment. We’re working hard at Amazon to dramatically narrow the golden window from diagnosis to treatment, and drone delivery marks a significant step forward.”

Although the company already delivers some prescriptions in 2 days via Amazon Prime, the drone method of delivery happens within an hour, according to the company. “Our drones fly over traffic, eliminating the excess time a customer’s package might spend in transit on the road,” explained Calsee Hendrickson, director of product and program management at Prime Air. “That’s the beauty of drone delivery, and medications were the first thing our customers said they also want delivered quickly via drone.”

Customers in College Station, Texas, are first to try out the service, which Amazon said has already begun, the Associated Press reported. Drones are programmed to fly from a secure pharmacy at a delivery center, and then descend down to 13 feet at a customer’s address and drop the padded package. The drones are expected to fly as high as 400 feet. The drone can also check that the area is clear of children and pets before dropping the package.

More than 500 medications will be available this way, including treatments for flu and pneumonia, the company said. The company also plans to add a third US location and cities in Italy and the United Kingdom to its drone delivery system by the end of 2024. By that same time, the company will introduce a new drone called the MK30. That drone is smaller, quieter, and flies farther, the AP reported.

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Associated Press Article

Amubarvimab Plus Romlusevimab Safe, Effective for COVID-19

Haymarket Media — Thu, 20 Apr 2023 13:00:00 +0000

HealthDay News — For nonhospitalized patients with COVID-19 at high risk for clinical progression, amubarvimab plus romlusevimab is safe and reduces the risk for hospitalization and/or death, according to a study published online April 18 in the Annals of Internal Medicine.

Teresa H. Evering, MD, from Weill Cornell Medicine in New York City, and colleagues examined the safety and efficacy of amubarvimab plus romlusevimab in a randomized phase 2 and 3 platform trial among nonhospitalized patients with COVID-19. The phase 3 analysis included 807 participants within 10 days of symptom onset at high risk for clinical progression, with a median age of 49 years.

The researchers found that hospitalizations and/or death occurred in 2.3 and 10.7% of participants in the amubarvimab plus romlusevimab and placebo groups, respectively, with an estimated reduction in events of 79%. Those with 5 or less and more than 5 days of symptoms at study entry had similar reductions. Participants randomly assigned to amubarvimab plus romlusevimab less frequently had grade 3 or higher treatment-emergent adverse events through day 28 than those randomly assigned to placebo (7.3 vs 16.1%); there were no severe infusion reactions or drug-related serious adverse events reported.

“Amubarvimab plus romlusevimab is safe and effective in reducing hospitalizations and deaths among those with mild-to-moderate COVID-19 at high risk for clinical progression and acquired infection before emergence of omicron variants,” the authors write.

Several authors disclosed financial ties to the pharmaceutical and biomedical industries.

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Abstract/Full Text

Anakinra Does Not Prevent Mechanical Ventilation in Severe COVID-19 Pneumonia

Haymarket Media — Tue, 11 Apr 2023 13:00:00 +0000

HealthDay News — Anakinra is not effective in reducing the need for mechanical ventilation among patients with severe COVID-19 pneumonia, according to a study published online April 7 in JAMA Network Open.

Patricia Fanlo, MD, PhD, from the Hospital Universitario de Navarra in Pamplona, Spain, and colleagues assessed the efficacy and safety of anakinra (100mg four times a day intravenously) versus standard of care alone for patients with severe COVID-19 pneumonia and hyperinflammation. The analysis included 179 patients treated at one of 12 Spanish hospitals (May 8, 2020, to March 1, 2021), with a follow-up period of one month.

The researchers found that the proportion of patients not requiring mechanical ventilation up to day 15 was not significantly different between groups (77.1% in the anakinra group vs 85.9% in the standard-of-care group; risk ratio, 0.90; 95% CI, 0.77 to 1.04; P =.16). Furthermore, anakinra did not result in any difference in time to mechanical ventilation (hazard ratio, 1.72; 95% CI, 0.82 to 3.62; P =.14). Lastly, there was no significant difference observed between groups in the proportion of patients not requiring invasive mechanical ventilation up to day 15 (risk ratio, 0.99; 95% CI, 0.88 to 1.11; P >.99).

“Although the primary and key secondary outcomes were not met, anakinra may have a role as an early treatment for patients with less-severe disease and inflammation,” the authors write.

The drugs for the study were provided by the company Swedish Orphan Biovitrum (Sobi), which manufactures anakinra.

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Abstract/Full Text

Annual Two-Dose SARS-CoV-2 Vaccination Campaign Beneficial

Haymarket Media — Wed, 27 Mar 2024 13:00:00 +0000

HealthDay News — Annual administration of a second dose of SARS-CoV-2 vaccine 5 months after the initial dose results in fewer hospitalizations and deaths, according to a study published online March 26 in the Annals of Internal Medicine.

Chad R. Wells, PhD, from the Yale School of Public Health in New Haven, Connecticut, and colleagues examined the effectiveness of an annual SARS-CoV-2 vaccination campaign in an age-structured dynamic transmission model in the US; the intervention included SARS-CoV-2 vaccination with an age-specific uptake similar to that of influenza vaccination.

The researchers found that in an annual vaccination campaign, the optimal timing between the first and second vaccine dose delivered to children younger than 2 years and adults aged 50 years and older was estimated to be 5 months. A second booster dose resulted in 123,869 fewer hospitalizations and 5524 fewer deaths compared with a single-dose campaign, averting $3.63 billion in costs over one year.

“Our study shows that adopting an annual vaccination campaign with the provision of a second dose to children younger than 2 years and adults aged 50 years or older can be a suitable approach to protect individuals against SARS-CoV-2 infection and associated outcomes,” the authors write.

Abstract/Full Text

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Antiretroviral Adherence Strategies

Haymarket Media — Tue, 21 Oct 2014 22:00:00 +0000

Antiretroviral Adherence Strategies

ANTIRETROVIRAL ADHERENCE STRATEGIES
Strategies	Examples
Provide an accessible, trustworthy, nonjudgmental multidisciplinary health care team	• Care providers, nurses, social workers, case managers, pharmacists, and medication managers
Strengthen early linkage to care and retention in care	• Encourage healthcare team participation in linkage to and retention in care • Use Anti-Retroviral Treatment and Access to Services Intervention (ARTAS) training, if available • Assist in making appointments and linkage to services to overcome barriers to care • Streamline Ryan White HIV/AIDS Program elligibility verification processes for uninsured and underinsured clients
Evaluate patient’s knowledge about HIV disease, prevention and treatment and, on the basis of the assessment, provide HIV‑related information	• Considering the patient’s current knowledge base, provide information about HIV, including the natural history of the disease, HIV viral load and CD4 count and expected clinical outcomes according to these parameters, and therapeutic and prevention consequences of non‑adherence
Identify facilitators, potential barriers to adherence, and necessary medication management skills before starting ART	• Assess patient’s cognitive competence and impairment • Assess behavioral and psychosocial challenges including depression, mental illnesses, levels of social support, high levels of alcohol consumption and active substance use, non‑disclosure of HIV serostatus and stigma • Identify and address language and literacy barriers • Assess beliefs, perceptions, and expectations about taking ART (eg, impact on health, side effects, disclosure issues, consequences of non‑adherence) • Ask about medication taking skills and foreseeable challenges with adherence (eg, past difficulty keeping appointments, adverse effects from previous medications, issues managing other chronic medications, need for medication reminders and organizers) • Assess structural issues including unstable housing, lack of income, unpredictable daily schedule, lack of prescription drug coverage, lack of continuous access to medications, transportation problems
Provide resources for the patient	• Resources to obtain prescription drug coverage, stable housing, social support, transportation assistance, and income and food security • Referrals for mental health and/or substance abuse treatment • Assistance during insurance enrollment periods to facilitate enrollment in plans that cover antiretrovirals
Involve the patient in ARV regimen election	• Review regimen potency, potential side effects, dosing, frequency, pill burden, storage requirements, food requirements, and consequences of nonadherence • Assess daily activities and tailor regimen to predictable and routine daily events • Consider preferential use of PI/r-based or dolutegravir-based ART if poor adherence is anticipated • Consider use of single tablet regimen formulations • Assess if cost/co‑payment for drugs can affect access to medications and adherence • Consider use of long-acting injectables in those with suppressed viral load, if clincally appropriate
Assess adherence at every clinic visit	• Monitor viral load as a strong biologic measure of adherence • Use a simple behavioral rating scale or self-reported assessment • Employ a structured format that normalizes or assumes less-than-perfect adherence and minimizes socially desirable or “white coat adherence” responses • Ensure that other members of the health care team also assess adherence
Use positive reinforcement to foster adherence success	• Inform patients of low or non-detectable levels of HIV viral load and increases in CD4 cell counts • Thank patients for attending appointments
Identify the type of and reasons for nonadherence	• Failure to understand dosing instructions • Complexity of regimen (eg, pill burden, size, dosing schedule, food requirements) • Pill aversion • Pill fatigue • Adverse effects • Inadequate understanding of drug resistance and its relationship to adherence • Unaware of appointments or appointments not scheduled with proper patient input • Cost-related issues • Depression, drug and alcohol use, homelessness, poverty • Stigma • Non-disclosure
Select from available effective adherence and retention interventions	• Use adherence-related tools to complement education and counseling interventions (eg, pill boxes, dose planners, reminder devices) • Use community resources to support adherence (eg, visiting nurses, community workers, family, peer advocates, transportation assistance) • Use patient prescription assistance programs • Use motivational interviews • Provide outreach for patients who drop out of care • Use peer or paraprofessional treatment navigators • Recognize positive clinical outcomes resulting from better adherence • Arrange for directly observed therapy (DOT) in patients in substance use treatment, if feasible • Enhance clinic support and structures to promote linkage and retention (eg, reminder calls, flexible scheduling, open access, active referrals, improved patient satisfaction) • Offer telehealth services for primary care, as well as supportive services when appropriate
Systematically monitor retention in care	• Record and follow up on missed visits
NOTES
ART = antiretroviral therapy; ARV = antiretroviral; PI/r = ritonavir-boosted protease inhibitor Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf. Updated December 6, 2023. Accessed December 14, 2023 [Table 19]. (Rev. 1/2024)

Antiretroviral Contraindications and Drug Interactions

Haymarket Media — Tue, 02 Apr 2013 16:00:00 +0000

Antiretroviral Contraindications and Drug Interactions

ANTIRETROVIRAL CONTRAINDICATIONS AND DRUG INTERACTIONS
Generic	Brand	Contraindications and Drug Interactions*
CCR5 Co‑Receptor Antagonists
maraviroc (MVC)	Selzentry	• Severe renal impairment or ESRD (CrCl <30mL/min) in patients taking concomitant potent CYP3A inhibitors or inducers. • Concomitant St. John’s wort: not recommended. • May affect, or be affected by, inhibitors or inducers of CYP3A and P-gp (eg, potentiated by ketoconazole, boceprevir, lopinavir/ ritonavir, ritonavir, darunavir/ ritonavir, saquinavir/ ritonavir, atazanavir; antagonized by rifampin, etravirine, efavirenz). • May be affected by inhibitors of OATP1B1 and MRP2. • Caution with antihypertensives.
Fusion Inhibitors
enfuvirtide (ENF, T‑20)	Fuzeon	• May cause false (+) ELISA test for HIV. • Increased risk of post-injection bleed with concomitant anticoagulants.
HIV-1 CAPSID INHIBITOR
lenacapavir	Sunlenca	• Concomitant strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort). • Concomitant moderate CYP3A inducers: not recommended. • May be potentiated by combined P-gp, UGT1A1, and strong CYP3A inhibitors: concomitant use is not recommended. • May potentiate drugs primarily metabolized by CYP3A within 9mos after the last dose of lenacapavir; refer to the prescribing information of sensitive CYP3A substrates. • Concomitant antiretrovirals (eg, atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir), antimycobacterials (eg, rifabutin, rifapentine), ergot derivatives (eg, dihydroergotamine, ergotamine, methylergonovine): not recommended. • Avoid with naloxegol; if unavoidable, decrease naloxegol dose and monitor. • Antagonized by oxcarbazepine, phenobarbital: not recommended; consider alternative anticonvulsants. • Potentiates digoxin, corticosteroids (eg, dexamethasone, hydrocortisone/cortisone), lovastatin, simvastatin, narcotic analgesics metabolized by CYP3A (eg, fentanyl, oxycodone), tramadol, oral midazolam, triazolam; use caution and monitor. • Potentiates direct oral anticoagulants (eg, rivaroxaban, dabigatran, edoxaban), PDE-5 inhibitors (eg, sildenafil, tadalafil, vardenafil). • Concomitant with tadalafil (to treat PAH): not recommended. • Titrate carefully when initiating buprenorphine or methadone in those taking lenacapavir; use lowest initial or maintenance dose. • When initiating lenacapavir in those taking buprenorphine or methadone, dose adjustment may be needed for these drugs.
HIV-1 GP120-DIRECTED ATTACHMENT INHIBITOR
fostemsavir	Rukobia	• Concomitant strong CYP3A4 inducers (eg, enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, St. John’s wort). • May be antagonized by strong CYP3A4 inducers. • May potentiate HCV direct-acting antivirals (eg, grazoprevir, voxilaprevir), statins drugs (eg, rosuvastatin, atorvastatin, fluvastatin, pitavastatin, simvastatin), ethinyl estradiol. • Caution when concomitant drugs with a known risk for Torsade de Pointes.
HIV‑1 Integrase Strand Transfer Inhibitors
cabotegravir	Apretude	• Unknown or positive HIV-1 status. • Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine. • Antagonized by strong UGT1A1 or 1A9 inducers. • Antagonized by rifabutin (see Adult dose).
cabotegravir	Vocabria	• Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine. • In combination with rilpivirine, see Edurant full labeling for additional contraindications. • Use of Cabenuva with rifabutin is contraindicated (see Cabenuva full labeling). • Concomitant other antiretrovirals: not recommended. • Antagonized by polyvalent cation-containing products (eg, aluminum or magnesium hydroxide, calcium carbonate); separate dosing by at least 2hrs before or 4hrs after cabotegravir.
dolutegravir	Tivicay	• Concomitant dofetilide. • Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. • Avoid etravirine unless co‑administered with atazanavir/ ritonavir, darunavir/ ritonavir, or lopinavir/ ritonavir. • Concomitant efavirenz, fosamprenavir/ ritonavir, tipranavir/ ritonavir, rifampin, or carbamazepine: adjust dose to 50mg twice daily. • May be affected by drugs that induce or inhibit UGT1A1, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. • May potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). • Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give dolutegravir 2hrs before or 6hrs after.
dolutegravir	Tivicay PD
raltegravir (RAL)	Isentress	• May be antagonized by UGT1A1 inducers (eg, rifampin) and potentiated by UGT1A1 inhibitors. • Concomitant aluminum and/or magnesium-containing antacids, other strong enzyme inducers (eg, carbamazepine, phenobarbital, phenytoin): not recommended. • Caution with concomitant drugs known to cause myopathy or rhabdomyolysis (eg, statins). • Isentress HD: concomitant calcium carbonate antacid, rifampin, tipranavir/ ritonavir, etravirine: not recommended.
raltegravir (RAL)	Isentress HD
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
doravirine	Pifeltro	• Concomitant strong CYP3A inducers (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John’s wort): discontinue for ≥4wks prior to starting Pifeltro. • Concomitant efavirenz, etravirine, nevirapine: not recommended. • May be antagonized by CYP3A inducers (see Contraindications). • May be potentiated by CYP3A inhibitors.
efavirenz (EVF)	—	• Avoid concomitant other efavirenz-containing products (eg, Atripla unless needed for dose adjustment with rifampin), atazanavir (treatment-experienced), posaconazole, boceprevir, simeprevir, atovaquone/ proguanil, alcohol, psychoactive, other NNRTIs or hepatotoxic drugs. • Caution with drugs metabolized by, or that affect activity of, CYP2B6, CYP2C9, CYP2C19, CYP3A4. • Efavirenz levels decreased by carbamazepine, phenytoin, phenobarbital, rifampin (adjust dose). • May decrease levels of indinavir, amprenavir, atazanavir, saquinavir, anticonvulsants, clarithromycin, calcium channel blockers (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), itraconazole, ketoconazole, lopinavir (adjust dose: see full labeling), maraviroc, bupropion, methadone, rifabutin (increase dose: see labeling), sertraline, simvastatin, atorvastatin, pravastatin, hormonal contraceptives (eg, norgestimate, etonogestrel), immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus), artemether/lumefantrine. • May affect or be affected by voriconazole (adjust dose). • Levels of both drugs increased with ritonavir (monitor liver function and for adverse events). • Closely monitor warfarin, anticonvulsants (esp. phenytoin, phenobarbital, carbamazepine), rifabutin, others. • Consider alternatives when concomitant drugs with a risk of QT prolongation (eg, clarithromycin, artemether/lumefantrine). • May cause false (+) cannabis screening test results.
etravirine (ETR)	Intelence	• Concomitant tipranivir/ ritonavir, fosamprenavir/ ritonavir, atazanavir/ cobicistat, darunavir/ cobicistat, PIs without ritonavir (eg, atazanavir, fosamprenavir, nelfinavir, indinavir), ritonavir (600mg twice daily), NNRTIs (eg, efavirenz, nevirapine, delavirdine, rilpivirine), anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), rifampin, rifapentine, St. John’s wort, elbasvir/ grazoprevir, simeprevir: not recommended. • Antagonizes dolutegravir (should only be used with etravirine when concomitant with darunavir/ ritonavir, lopinavir/ ritonavir, or atazanavir/ ritonavir). • May affect, or be affected by, drugs that induce or inhibit, or that are substrates of, CYP3A4, CYP2C9, CYP2C19 (eg, azole antifungals, immunosuppressants); monitor. • May antagonize antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, lidocaine, mexiletine, propafenone, quinidine) (monitor), sildenafil, clopidogrel (consider alternatives), antimalarials (eg, artemether/lumefantrine). • May be antagonized by systemic dexamethasone (consider alternatives). • May potentiate diazepam. • Clarithromycin (consider azithromycin for treating MAC). • Adjust statin (except pravastatin, rosuvastatin), maraviroc, daclatasvir dose. • Monitor digoxin, warfarin, buprenorphine, buprenorphine/naloxone, methadone. • Rifabutin (adjust dose with etravirine monotherapy).
nevirapine (NVP)	Viramune	• Moderate to severe (Child-Pugh B or C) hepatic impairment. Use as part of occupational or non-occupational post-exposure prophylaxis regimens. • Possible increased adverse reactions with concomitant efavirenz: not recommended. • Concomitant other NNRTIs: not recommended. • Potentiated by fluconazole (monitor). • Antagonizes atazanavir, fosamprenavir without ritonavir, ketoconazole, itraconazole, boceprevir, telaprevir: not recommended, clarithromycin (consider alternative). • Antagonized by St. John’s wort, rifampin: not recommended. • Antagonizes methadone (monitor for withdrawal symptoms; increase methadone dose if needed), oral contraceptives (use nonhormonal contraception; monitor). • May antagonize other drugs metabolized by CYP3A4 or CYP2B6. • Do not give lopinavir/ritonavir tabs or oral soln once daily with nevirapine (see full labeling). • Monitor warfarin, carbamazepine, clonazepam, ethosuximide, rifabutin (caution), other CYP450 substrates.
nevirapine (NVP)	Viramune XR
rilpivirine	Edurant	• Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than single dose), St. John’s wort. • Use of Cabenuva with rifabutin is contraindicated (see Cabenuva full labeling). • Concomitant NNRTIs (eg, delavirdine): not recommended. • Concomitant drugs with a known risk for torsades de pointes: consider alternatives to rilpivirine. • Antagonized by CYP3A inducers (see Contraindications). • May be potentiated by CYP3A inhibitors (eg, azole antifungals [monitor for breakthrough fungal infections], clarithromycin, erythromycin, telithromycin [consider azithromycin use]). • Concomitant methadone; monitor. • Separate didanosine, antacids (by at least 2hrs before or at least 4hrs after) and H2-receptor antagonists (by at least 12hrs before or 4hrs after rilpivirine); drugs that increase gastric pH may result in decreased plasma concentrations.
Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs)
abacavir sulfate (ABC)	Ziagen	• *Presence of HLA-B5701 allele. • Prior hypersensitivity reaction to abacavir (see full labeling). • Moderate or severe hepatic impairment.** • May antagonize methadone. • May be potentiated by ethanol.
abacavir (ABC)/ lamivudine (3TC)	Epzicom	• *Presence of HLA-B5701 allele. • Prior hypersensitivity reaction to any of the components (see full labeling). • Moderate or severe hepatic impairment.** • Avoid concomitant sorbitol-containing products. • May antagonize methadone. • Potentiates riociguat; may need to reduce riociguat dose. • Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.
abacavir (ABC)/ lamivudine (3TC)/ zidovudine (ZDV)	Trizivir	• *Presence of HLA-B5701 allele. • Prior hypersensitivity reaction to any of the components (see full labeling). • Moderate or severe hepatic impairment.** • Avoid concomitant stavudine, doxorubicin, nucleoside analogues (eg, ribavirin), sorbitol-containing products. • Increased hematologic toxicity with ganciclovir, interferon alfa, ribavirin, other bone marrow suppressants or cytotoxic drugs. • Abacavir may antagonize methadone. • Potentiates riociguat; may need to reduce riociguat dose. • Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.
emtricitabine (FTC)	Emtriva	• Avoid concomitant drugs that contain emtricitabine or lamivudine.
emtricitabine (FTC)/ tenofovir alafenamide (TAF)	Descovy	• PrEP in individuals with unknown or positive HIV-1 status. • Concomitant drugs that strongly affect P-gp activity may lead to changes in TAF absorption. • Avoid with concurrent or recent use of nephrotoxic agents. • Concomitant tipranavir/ ritonavir, antimycobacterials (eg, rifabutin, rifampin, rifapentine), St. John’s wort: not recommended. • May be antagonized by anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin; consider alternatives). • May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs).
emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF)	Truvada	• PrEP in individuals with unknown or positive HIV-1 status. • Potentiates didanosine toxicity (>60kg: reduce dose of didanosine); discontinue didanosine if toxicity develops. • Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, adefovir dipivoxil, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose NSAIDs). • Avoid concomitant or recent use of nephrotoxic agents. • Potentiated by lopinavir/ ritonavir, ritonavir-boosted atazanavir or darunavir; monitor for toxicity; discontinue if occurs. • Concomitant atazanavir: must give with ritonavir. • Tenofovir levels increased by concomitant ledipasvir/ sofosbuvir, sofosbuvir/ velpatasvir, or sofosbuvir/ velpatasvir/ voxilaprevir; monitor for toxicity.
lamivudine (3TC)	Epivir	• Avoid concomitant sorbitol-containing products. • Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim). • Monitor for treatment-associated toxicities (esp. hepatic decompensation) with interferon-alpha with or without ribavirin.
lamivudine/tenofovir disoproxil fumarate	Cimduo	• Avoid concomitant sorbitol-containing drugs. • Caution with drugs eliminated by active organic cationic secretion (eg, trimethoprim). • Monitor for toxicity (eg, hepatic decompensation) with interferon-alfa (+/– ribavirin); reduce or discontinue one or both drugs as needed. • Concomitant atazanavir 300mg: give with ritonavir. • Tenofovir levels increased by lopinavir/ritonavir, atazanavir/ritonavir, darunavir/ritonavir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir: monitor for adverse reactions and discontinue if occurs. • Concomitant ledipasvir/sofosbuvir: if without protease inhibitor/ritonavir or protease inhibitor/cobicistat combination: monitor; if with protease inhibitor/ritonavir or protease inhibitor/cobicistat combination: consider alternative HCV or antiretroviral therapy; if coadministration necessary, monitor. • Avoid concomitant or recent use of nephrotoxic agents. • Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs); consider alternatives to NSAIDs.
lamivudine (3TC)/ zidovudine (ZDV)	Combivir	• Avoid concomitant stavudine, doxorubicin, nucleoside analogues (eg, ribavirin), sorbitol-containing products. • Increased hematologic toxicity with ganciclovir, interferon alpha, ribavirin, other bone marrow suppressants or cytotoxic drugs. • Monitor for treatment-associated toxicities (eg, hepatic decompensation) with interferon-alpha with or without ribavirin.
stavudine (d4T)	—	• Avoid concomitant zidovudine. • Increased risk of toxicity with neurotoxic, hepatotoxic, or pancreatotoxic drugs (eg, didanosine and/or hydroxyurea); avoid. • Caution with doxorubicin, ribavirin. • Monitor for treatment-associated toxicities with interferon-alpha with or without ribavirin.
tenofovir disoproxil fumarate (TDF)	Viread	• Concomitant adefovir dipivoxil for chronic HBV: not recommended. • Avoid concomitant or recent use of nephrotoxic agents. • Potentiates didanosine levels; monitor closely. • Monitor drugs that reduce renal function or compete for renal tubular secretion (eg, cidofovir, acyclovir, valacyclovir, ganciclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). • Concomitant atazanavir: must give with ritonavir. • Potentiated by concomitant lopinavir/ ritonavir, ritonavir-boosted atazanavir or darunavir, ledipasvir/ sofosbuvir, sofosbuvir/velpatasvir; monitor for toxicity.
zidovudine (ZDV)	Retrovir	• Avoid concomitant stavudine, doxorubicin, nucleoside analogues (eg, ribavirin). • Increased hematologic toxicity with ganciclovir, interferon alpha, ribavirin, other bone marrow suppressants or cytotoxic drugs. • Monitor for treatment-associated toxicities (eg, hepatic decompensation) with interferon alpha with or without ribavirin.
Pharmacokinetic Enhancer
cobicistat	Tybost	• Concomitant alfuzosin, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, colchicine (in renal and/or hepatic impairment), rifampin, irinotecan (with atazanavir only), lurasidone, pimozide, ergots, cisapride, St. John’s wort, lomitapide, lovastatin, simvastatin, drospirenone/ ethinyl estradiol (with atazanavir only), nevirapine (with atazanavir only), sildenafil (as Revatio for PAH), indinavir (with atazanavir only), triazolam, oral midazolam. • Concomitant nephrotoxic agent with cobicistat + tenofovir disoproxil fumarate: not recommended. • Concomitant darunavir 600mg twice daily or darunavir in combination with efavirenz, nevirapine, etravirine; atazanavir in combination with etravirine or efavirenz (in treatment-experienced); more than 1 antiretroviral that requires PK enhancement, other HIV-1 protease inhibitors (eg, fosamprenavir, saquinavir, tipranavir), rivaroxaban, voriconazole, boceprevir, simeprevir, salmeterol, avanafil: not recommended. • Concomitant lopinavir/ ritonavir, other ritonavir- or cobicistat-containing fixed-dose combination tabs or regimens: not recommended. • May need to adjust dose of dasatinib, nilotinib, colchicine, sildenafil, tadalafil, vardenafil, perphenazine, risperidone, thioridazine, buprenorphine, buprenorphine/ naloxone, methadone, tramadol, bosentan, rifabutin, and sedatives/ hypnotics; see full labeling. • May potentiate apixaban (with atazanavir or darunavir); betrixaban, dabigatran, edoxaban (with atazanavir). • Concomitant maraviroc: give maraviroc 150mg twice daily. • Concomitant quetiapine: consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor. • Monitor with antiarrhythmics, digoxin, warfarin, clonazepam, SSRIs, TCAs, trazodone, antifungals, fentanyl, immunosuppressants, other statins (eg, atorvastatin, rosuvastatin), β-blockers, calcium channel blockers. • Concomitant antibacterials (eg, clarithromycin, erythromycin, telithromycin), CYP3A-inducing anticonvulsants that are not contraindicated (eg, eslicarbazepine, oxcarbazepine), corticosteroids (eg, oral dexamethasone, betamethasone): consider alternatives. • Concomitant vincristine, vinblastine: monitor for hematologic or GI adverse effects. • Concomitant hormonal contraceptives: consider additional or alternative (non-hormonal) contraception. • Separate dosing with concomitant H2 receptor antagonists, PPIs (not recommended in treatment-experienced), or antacids (at least 2hrs).
Protease Inhibitors (PIs)
atazanavir sulfate (ATV)	Reyataz	• Concomitant alfuzosin, amiodarone (with ritonavir), rifampin, irinotecan, lurasidone (with ritonavir), pimozide, quinidine (with ritonavir), triazolam, oral midazolam, ergots, cisapride, elbasvir/grazoprevir, glecaprevir/pibrentasvir, St. John’s wort, lomitapide, lovastatin, simvastatin, sildenafil (for PAH), indinavir, nevirapine. • Concomitant other protease inhibitors (excluding ritonavir and saquinavir), sofosbuvir/ velpatasvir/ voxilaprevir, colchicine (in those with renal or hepatic impairment), salmeterol: not recommended. • Avoid atazanavir + ritonavir with boceprevir, fluticasone, rivaroxaban, voriconazole. • Concomitant paclitaxel, repaglinide, carbamazepine, phenytoin, phenobarbital, bosentan, or buprenorphine without ritonavir: not recommended. • Caution with UGT1A1 or CYP3A substrates (eg, IV midazolam, CCBs, statins [eg, atorvastatin, rosuvastatin (max 10mg/day); use lowest dose necessary], PDE5 inhibitors: reduce doses of these to treat ED; max 25mg sildenafil in 48hrs; max 2.5mg vardenafil in 24hrs [atazanavir] or 72hrs [atazanavir + ritonavir]; max 10mg tadalafil in 72hrs; tadalafil to treat PAH [see full labeling]). • May be antagonized by CYP3A inducers. • Consider reducing diltiazem or clarithromycin dose by 50%; rifabutin dose by 75%. • Antagonized by H2-blockers (see full labeling). • Give PPIs 12hrs before atazanavir + ritonavir; avoid in therapy-experienced. • Give 2hrs before or 1hr after antacids, buffered or enteric coated didanosine. • Antagonized by efavirenz, bosentan, tenofovir DF (see dose). • Potentiates saquinavir, tenofovir DF, trazodone (caution), fluticasone, ketoconazole, itraconazole, buprenorphine (reduce dose), quetiapine (if co-administration needed, reduce quetiapine dose to 1/6 of current dose). • Atazanavir + ritonavir may potentiate direct-acting oral anticoagulants (eg, betrixaban, dabigatran, edoxaban). • Caution with oral contraceptives (eg, ethinyl estradiol + norgestimate or norethindrone). • Concomitant other hormonal contraceptives (eg, patches, vaginal rings, injectables, other progestogen-containing products, or <25mcg ethinyl estradiol): use alternative methods. • Monitor with antiarrhythmics, warfarin, tricyclics, rifabutin, apixaban, rivaroxaban, immunosuppressants.
darunavir (DRV)	Prezista	• Concomitant alfuzosin, colchicine (in renal and/or hepatic impairment), dronedarone, ivabradine, ranolazine, rifampin, lurasidone, pimozide, ergots, cisapride, oral midazolam, triazolam, St. John’s wort, elbasvir/ grazoprevir, lomitapide, lovastatin, simvastatin, naloxegol, sildenafil (for PAH). • Concomitant voriconazole, salmeterol, boceprevir, glecaprevir/ pibrentasvir, simeprevir, apixaban (see full labeling), rivaroxaban, rifapentine, everolimus, irinotecan (unless no alternatives), avanafil, ticagrelor, clopidogrel, protease inhibitors (eg, lopinavir/ ritonavir, saquinavir, others): not recommended. • Potentiates carbamazepine, antipsychotics (eg, perphenazine, risperidone, thioridazine), dabigatran, edoxaban, TCAs, trazodone, IV midazolam, rifabutin (reduce dose by 75%), digoxin, HMG-CoA reductase inhibitors (eg, pravastatin, atorvastatin, rosuvastatin; use lowest dose necessary; max atorvastatin dose is 20mg/day), sildenafil, vardenafil, tadalafil (adjust doses), other sedatives/ hypnotics, bosentan (see full labeling), maraviroc (max 150mg twice daily), colchicine (dose adjustments: see full labeling), quetiapine (reduce quetiapine dose by ⅙ or consider alternative antiretrovirals), dasatinib, nilotinib, vinca alkaloids, fesoterodine (max 4mg/day), solifenacin (max 5mg/day), corticosteroids (consider alternatives [eg, beclomethasone, prednisone, prednisolone] for long-term use). • Potentiates, and is potentiated by, indinavir, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), isavuconazole; monitor. • Antagonizes sertraline, paroxetine, phenytoin, phenobarbital (monitor levels), omeprazole (max 40mg/day). • Antagonized by CYP3A-inducing corticosteroids (eg, systemic dexamethasone or others); consider alternatives. • Caution with antimalarials (artemether, lumefantrine). • Monitor carbamazepine, antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine), calcium channel blockers, β-blockers, warfarin, digoxin, clonazepam, immunosuppressants (eg, tacrolimus, sirolimus, cyclosporine), fentanyl, oxycodone, tramadol, buprenorphine, buprenorphine/ naloxone, methadone. • Reduce concomitant clarithromycin dose in renal impairment. • Concomitant hormonal contraceptives (eg, drosperinone): monitor for hyperkalemia; estrogen-containing contraceptives: consider additional or alternative (non-hormonal) contraception. • Separate dosing of didanosine at least 1hr before or 2hrs after.
fosamprenavir calcium (FOS‑APV)	Lexiva	• Concomitant alfuzosin, cisapride, lurasidone, pimozide, ergots, midazolam, triazolam, St. John’s wort, rifampin, lovastatin, simvastatin, delavirdine, sildenafil (as Revatio for PAH). • Concomitant flecainide, or propafenone with ritonavir-boosted fosamprenavir. • Life-threatening arrhythmias possible with amiodarone, lidocaine (systemic), quinidine. • Concomitant salmeterol, boceprevir, simeprevir, ketoconazole or itraconazole (doses >200mg/day), paritaprevir/ ritonavir/ ombitasvir/ dasabuvir, or nevirapine without ritonavir: not recommended. • Reduce rifabutin dose by at least ½ (or by 75% if with ritonavir) and monitor for neutropenia (do weekly CBCs). • Potentiates atorvastatin (max atorvastatin 20mg/day), sildenafil, tadalafil, vardenafil; reduce doses of these. • May potentiate fluticasone (consider alternative therapy), trazodone (reduce trazodone dose). • Monitor antiarrhythmics (eg, amiodarone), anticonvulsants (eg, phenytoin), H₂ blockers, immunosuppressants, tricyclics, warfarin, drugs that affect or are affected by CYP3A4 (eg, azole antifungals, benzodiazepines, calcium channel blockers, NNRTIs, protease inhibitors, statins, steroids). • May antagonize, or be antagonized by hormonal contraceptives (use non-hormonal methods), methadone, paroxetine. • Concomitant dolutegravir (with ritonavir-boosted fosamprenavir): give dolutegravir 50mg twice daily; use alternative if known or suspected integrase inhibitor resistance. • Concomitant bosentan, colchicine, quetiapine, maraviroc (adjust doses; see full labeling).
lopinavir (LPV)/ ritonavir (RTV)	Kaletra	• Concomitant alfuzosin, ranolazine, dronedarone, colchicine (in renal and/or hepatic impairment), lurasidone, pimozide, ergots, cisapride, elbasvir/ grazoprevir, lomitapide, lovastatin, simvastatin, sildenafil [as Revatio for PAH], oral midazolam, triazolam, apalutamide, rifampin, St. John’s wort. • Concomitant salmeterol, boceprevir, simeprevir, glecaprevir/ pibrentasvir, sofosbuvir/ velpatasvir/ voxilaprevir, ombitasvir/ parataprevir/ ritonavir and dasabuvir: not recommended. • Avoid oral soln with metronidazole, disulfiram. • Potentiates statins metabolized by CYP3A; use atorvastatin with caution and at the lowest necessary doses; do not exceed rosuvastatin 10mg daily. • Potentiates sildenafil, vardenafil, tadalafil (reduce dose of these); avanafil (avoid). • Potentiates anticancer agents (eg, abemaciclib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine); avoid or reduce doses (see full labeling). • Potentiates fostamatinib; monitor for toxicities; may require dose reduction. • Concomitant elagolix 200mg twice daily for >1 month: not recommended. • Concomitant colchicine (see full labeling). • Potentiates bosentan (see full labeling). • Increases levels of antiarrhythmics (eg, amiodarone, bepridil, systemic lidocaine, quinidine), dihydropyridine CCBs, immunosuppressants (monitor); ketoconazole, itraconazole (avoid high doses), isavuconazonium sulfate (caution); bedaquiline (use only if benefit outweighs the risk); rifabutin (reduce rifabutin dose and monitor); clarithromycin (reduce clarithromycin dose in renal dysfunction), trazodone (reduce trazodone dose), maraviroc (give max maraviroc 150mg twice daily), quetiapine (reduce dose). • Monitor with other antiretrovirals (eg, tenofovir disoproxil), warfarin. • Avoid concomitant rivaroxaban; increased bleeding risk. • Decrease levels of atovaquone, methadone, bupropion, estrogen-containing oral contraceptives (use alternative method or additional barrier contraception), voriconazole (avoid and use alternatives). • Lopinavir levels decreased by anticonvulsants (eg, carbamazepine, phenobarbital, phenytoin), efavirenz, nevirapine, tipranavir. • Lopinavir levels may be increased by delavirdine, CYP3A inhibitors. • May decrease lamotrigine, valproate, zidovudine or abacavir levels. • Give didanosine 1 hour before or 2 hours after. • Avoid concomitant with other drugs that prolong the QT interval. • Antagonized by corticosteroids (eg, oral dexamethasone, betamethasone, budesonide); consider alternatives.
nelfinavir mesylate (NFV)	Viracept	• CYP3A substrates that may cause serious events if blood levels are elevated (eg, cisapride, pimozide, oral midazolam, triazolam, lovastatin, simvastatin, ergots, amiodarone, quinidine, alfuzosin, rifampin, St. John’s wort, sildenafil [Revatio; when used to treat PAH]). • Salmeterol: not recommended. • Potentiates CYP3A substrates (eg, dihydropyridine calcium channel blockers, cyclosporine, tacrolimus, sirolimus, rifabutin, rosuvastatin, atorvastatin [use lowest dose necessary; max atorvastatin dose is 40mg/day]), PDE5 inhibitors (adjust dose: see literature), phenytoin (monitor). • Potentiates fluticasone (caution and consider alternatives w. long-term use), trazodone (use lower dose), bosentan, colchicine (adjust dose: see literature). • Nelfinavir levels decreased by CYP3A inducers (eg, phenytoin, carbamazepine, phenobarbital) or CYP2C19 inducers. • Nelfinavir levels increased by CYP3A or CYP2C19 inhibitors. • Antagonizes methadone, oral contraceptives (use additional or alternative contraception). • Indinavir, ritonavir, saquinavir increase nelfinavir levels. • Concomitant azithromycin: monitor for azithromycin toxicity (eg, elevated liver enzymes). • Administer didanosine 1hr before or 2hrs after nelfinavir. • Monitor INR with warfarin. • Others: see full labeling.
ritonavir (RTV)	Norvir	• Concomitant alfuzosin, ranolazine, amiodarone, dronedarone, flecainide, quinidine, propafenone, voriconazole (w. ritonavir ≥400mg every 12hrs), colchicine (in renal and/or hepatic impairment), lurasidone, pimozide, ergots, cisapride, lomitapide, lovastatin, simvastatin, sildenafil (as Revatio for PAH), oral midazolam, triazolam, apalutamide, St. John’s Wort. • Concomitant glecaprevir/pibrentasvir, simeprevir, salmeterol, high-dose or long-term meperidine, ketoconazole or itraconazole >200mg/day, elagolix 400mg/day for >1 month: not recommended. • May affect or be affected by CYP3A4, 2D6, 2C9, 1A2, 2C19, 2B6, or glucuronyl transferase substrates. • Potentiates other protease inhibitors, maraviroc, tramadol, propoxyphene, antidepressants (eg, SSRIs, tricyclics, nefazodone, desipramine, trazodone), dronabinol, quinine, bosentan, β-blockers (eg, metoprolol, timolol), CCBs (eg, diltiazem, nifedipine, verapamil), PDE-5 inhibitors (eg, avanafil, sildenafil, tadalafil, vardenafil), antipsychotics (eg, perphenazine, risperidone, thioridazine), sedative/ hypnotics (eg, buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, statins (eg, atorvastatin, rosuvastatin), methamphetamine; may need dose reductions. • Potentiates anticancer agents (eg, abemaciclib, dasatinib, encorafenib, ibrutinib, ivosidenib, neratinib, nilotinib, venetoclax, vinblastine, vincristine); avoid or reduce doses (see full labeling). • Increases levels of disopyramide, lidocaine, mexiletine, carbamazepine, clonazepam, ethosuximide, digoxin, immunosuppressants, glucocorticoids (eg, dexamethasone, betamethasone, fluticasone, budesonide, prednisone; consider alternatives); monitor. • Antagonizes raltegravir, divalproex, lamotrigine, phenytoin, bupropion, atovaquone, theophylline (monitor), methadone (consider dose increase), oral contraceptives (consider alternatives). • Antagonized by rifampin. • Potentiated by delavirdine. • Avoid metronidazole, disulfiram, rivaroxaban (increased bleeding risk). • Reduce rifabutin dose by at least ¾, quetiapine to ⅙ of current dose, clarithromycin dose in renal dysfunction. • Concomitant bedaquiline: use only if benefit outweighs the risk. • Monitor fentanyl, parenteral midazolam, warfarin.
tipranavir (TPV)	Aptivus	• Moderate to severe hepatic impairment (Child-Pugh B−C). • Concomitant potent CYP3A inducers or substrates (eg, alfuzosin, amiodarone, bepridil, flecainide, propafenone, quinidine, rifampin, ergots, cisapride, St. John’s wort, lovastatin, simvastatin, pimozide, lurasidone, sildenafil [as Revatio for PAH], oral midazolam, triazolam). • Concomitant colchicine (in renal or hepatic impairment). • Concomitant etravirine, fosamprenavir, lopinavir, saquinavir, atazanavir, salmeterol, fluticasone, atorvastatin, or fluconazole, ketoconazole, itraconazole >200mg/day: not recommended. • May be potentiated by enfuvirtide. • Antagonized by carbamazepine, phenobarbital, phenytoin, buprenorphine/naloxone. • Potentiates sildenafil, tadalafil, vardenafil, IV midazolam, trazodone, colchicine, desipramine (monitor), SSRIs, clarithromycin (in renal impairment); reduce dose: see full labeling. • Antagonizes abacavir, didanosine, zidovudine, estrogens (as HRT; monitor for deficiency), methadone, meperidine, omeprazole, dolutegravir, raltegravir, valproic acid. • Reduce rifabutin dose by 75%, quetiapine to ⅙ of current dose (if no alternative). • Monitor hypoglycemics, immunosuppressants, CCBs, warfarin. • Increased risk of bleeding with concomitant anticoagulants, antiplatelet agents, high-dose Vit.E. • Separate dosing of didanosine by ≥2hrs. • Bosentan: adjust dose (see full labeling). • Caps: avoid metronidazole, disulfiram. • Oral soln: avoid high-dose Vit.E supplements.
Multiclass Fixed-Dose Combination
abacavir/ dolutegravir/ lamivudine	Triumeq	• *Presence of HLA-B5701 allele. • Previous hypersensitivity reaction to any of the components. • Concomitant dofetilide. • Moderate or severe hepatic impairment.** • Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. • Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. • Concomitant etravirine without atazanavir/ ritonavir, darunavir/ ritonavir, or lopinavir/ ritonavir: not recommended. • Concomitant efavirenz, fosamprenavir/ ritonavir, tipranavir/ ritonavir, carbamazepine, rifampin: give additional dolutegravir 50mg separated by 12hrs from Triumeq. • May potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). • Avoid concomitant sorbitol-containing products. • Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/ calcium supplements (also can give together with a meal): give Triumeq 2hrs before or 6hrs after. • Ethanol may increase abacavir levels. • Abacavir may antagonize methadone. • Potentiates riociguat; may need to reduce riociguat dose.
abacavir/ dolutegravir/ lamivudine	Triumeq PD
atazanavir/ cobicistat	Evotaz	• Concomitant alfuzosin, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, colchicine (in renal/ hepatic impaired), rifampin, irinotecan, lurasidone, pimozide, triazolam, oral midazolam, ergots, cisapride, elbasvir/ grazoprevir, glecaprevir/ pibrentasvir, St. John’s wort, lomitapide, lovastatin, simvastatin, drospirenone/ ethinyl estradiol, nevirapine, sildenafil (for PAH), indinavir. • Separate dosing with concomitant H2 receptor antagonists, PPIs (not recommended in treatment-experienced), antacids, enteric-coated didanosine. • Concomitant tenofovir DF with concomitant or recent nephrotoxic agents, other antiretrovirals that require CYP3A inhibition (eg, HIV protease inhibitors, elvitegravir), ritonavir or ritonavir-containing products, CYP2C8 substrates with narrow therapeutic indices (eg, paclitaxel, repaglinide), H₂ receptor antagonists (in treatment-experienced), efavirenz, etravirine, boceprevir, simeprevir, sofosbuvir/ velpatasvir/ voxilaprevir, apixaban, rivaroxaban, dabigatran etexilate, atorvastatin, avanafil, inhaled/ nasal steroids, salmeterol, voriconazole: not recommended. • May need to adjust dose of insulin, antidiabetics, dasatinib, nilotinib, sildenafil, tadalafil, vardenafil, perphenazine, risperidone, thioridazine, buprenorphine, naloxone, methadone, tramadol, bosentan, rifabutin, sedatives/ hypnotics, rosuvastatin (max 10mg/day); monitor. • Concomitant maraviroc: give maraviroc 150mg twice daily. • Potentiates quetiapine: consider alternative antiretrovirals; if coadministration necessary, reduce quetiapine to ⅙ of current dose and monitor. • Monitor concomitant antiarrhythmics, digoxin, vincristine, vinblastine, warfarin, clonazepam, lamotrigine, SSRIs, TCAs, trazodone, fentanyl, immunosuppressants, other statins, β-blockers, CCBs. • Concomitant clarithromycin, erythromycin, telithromycin, CYP3A-inducing anticonvulsants (eg, eslicarbazepine, oxcarbazepine), systemic corticosteroids (eg, dexamethasone): consider alternatives. • Use alternative non-hormonal methods of contraception.
bictegravir/ emtricitabine/ tenofovir alafenamide	Biktarvy	• Concomitant dofetilide, rifampin. • Concomitant other antiretrovirals: not recommended. • May potentiate concomitant OCT2 and MATE1 substrates (eg, dofetilide). • May be affected by drugs that induce or inhibit CYP3A and UGT1A1. • Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. • May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). • May be antagonized by anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin); consider alternatives. • Concomitant rifabutin, rifapentine, St. John’s wort: not recommended. • Concomitant antacids (containing Al/Mg): give Biktarvy at least 2hrs before or 6hrs after. • Concomitant oral iron/ calcium supplements or antacids: can take together with food. • Routine coadministration (under fasting conditions) with, or 2hrs after, oral iron/ calcium supplements or antacids: not recommended. • May potentiate metformin (refer to metformin labeling).
cabotegravir/rilpivirine	Cabenuva	• Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (more than 1 dose), St. John’s wort. • Concomitant other antiretroviral drugs: not recommended. • Cabotegravir: antagonized by strong UGT1A1 or 1A9 inducers. • Rilpivirine: antagonized by CYP3A inducers or may be potentiated by CYP3A inhibitors. • Concomitant drugs with a known risk for torsade de pointes (eg, azithromycin, clarithromycin, erythromycin); caution; consider alternatives. • Concomitant methadone; monitor; may need dose adjustment.
darunavir/ cobicistat	Prezcobix	• Concomitant alfuzosin, colchicine (in renal/ hepatic impaired), dronedarone, ivabradine, ranolazine, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergots, cisapride, St. John’s wort, elbasvir/ grazoprevir, lomitapide, lovastatin, simvastatin, oral midazolam, triazolam, naloxegol, sildenafil (for PAH). • Concomitant tenofovir DF with concomitant or recent nephrotoxic agents, darunavir- or cobicistat-containing products, ritonavir, or other antiretrovirals that require PK boosting (eg, another protease inhibitor, elvitegravir), efavirenz, etravirine, nevirapine, apixaban (see full labeling), rivaroxaban, voriconazole, rifapentine, glecaprevir/ pibrentasvir, simeprevir, everolimus, irinotecan (unless no alternatives), salmeterol, avanafil, ticagrelor, clopidogrel: not recommended. • May need to adjust dose of dasatinib, nilotinib, colchicine, sildenafil, tadalafil, vardenafil, perphenazine, risperidone, thioridazine, buprenorphine, buprenorphine/ naloxone, methadone, tramadol, bosentan, rifabutin (give 150mg every other day), sedatives/ hypnotics. • Concomitant maraviroc (give 150mg twice daily), fesoterodine (max 4mg/day), solifenacin (max 5mg/day). • Concomitant quetiapine: consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor. • Monitor with antiarrhythmics, digoxin, dabigatran, edoxaban, warfarin, clonazepam, SSRIs, TCAs, trazodone, antimalarials (eg, artemether, lumefantrine), itraconazole (max 200mg/day), ketoconazole (max 200mg/day), isavuconazole, posaconazole, fentanyl, oxycodone, immunosuppressants, β-blockers, calcium channel blockers. • Concomitant other statins (eg, atorvastatin (max 20mg/day), fluvastatin, pitavastatin, pravastatin, rosuvastatin (max 20mg/day): start at low dose, titrate and monitor. • Concomitant antibacterials (eg, clarithromycin, erythromycin, telithromycin), CYP3A-inducing anticonvulsants that are not contraindicated (eg, eslicarbazepine, oxcarbazepine): consider alternatives. • Potentiate corticosteroids; consider alternatives (eg, beclomethasone, prednisone, prednisolone) for long-term use. • Antagonized by CYP3A-inducing corticosteroids (eg, systemic dexamethasone or others); consider alternatives. • Concomitant vincristine, vinblastine: consider temporarily withholding cobicistat-containing regimen if significant hematologic or GI adverse events develop. • Concomitant hormonal contraceptives (eg, drosperinone): monitor for hyperkalemia; estrogen-containing contraceptives: consider additional or alternative (non-hormonal) contraception. • Separate dosing of didanosine at least 1hr before or 2hrs after.
darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide	Symtuza	• Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, colchicine (in renal/ hepatic impairment), rifampin, lurasidone, pimozide, dronedarone, ivabradine, ranolazine, ergots, cisapride, St. John’s wort, elbasvir/ grazoprevir, lomitapide, lovastatin, simvastatin, naloxegol, sildenafil (for PAH), oral midazolam, triazolam. • Concomitant other antiretroviral agents, rivaroxaban, voriconazole, rifabutin (if needed, give 150mg every other day), rifapentine, glecaprevir/ pibrentasvir, everolimus, irinotecan (unless no alternatives), salmeterol, avanafil, ticagrelor, clopidogrel: not recommended. • Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). • Monitor with antiarrhythmics, digoxin, dabigatran, edoxaban, dasatinib, nilotinib (see full labeling), apixaban, clonazepam, SSRIs, TCAs, antimalarials (eg, artemether, lumefantrine), trazodone, itraconazole, ketoconazole, colchicine (see full labeling), antipsychotics, quetiapine (consider alternative antiretrovirals or reduce quetiapine to ⅙ of current dose), β-blockers, calcium channel blockers, fentanyl, oxycodone, immunosuppressants, tramadol (reduce dose), PDE5 inhibitors (see full labeling), sedatives/hypnotics, IV midazolam, fesoterodine (max 4mg/day), solifenacin (max 5mg/day). • Concomitant other statins [eg, atorvastatin (max 20mg/day), fluvastatin, pitavastatin, pravastatin, rosuvastatin (max 20mg/day)]: start at low dose, titrate and monitor. • Concomitant antibacterials (eg, clarithromycin, erythromycin, telithromycin), CYP3A-inducing anticonvulsants that are not contraindicated (eg, eslicarbazepine, oxcarbazepine), CYP3A-inducing corticosteroids (eg, systemic dexamethasone or others): consider alternatives. • Concomitant vincristine, vinblastine: consider temporarily withholding cobicistat-containing regimen if significant hematologic or GI adverse events develop. • Concomitant hormonal contraceptives (eg, drosperinone): monitor for hyperkalemia; other estrogen based contraceptives: consider additional or alternative (non-hormonal) contraception. • Discontinue bosentan ≥36hrs prior to initiation of Symtuza; resume after ≥10 days following initiation. • Concomitant buprenorphine, buprenorphine/ naloxone, methadone; use lowest initial or maintenance dose and titrate. • Monitor INR with warfarin.
dolutegravir/ lamivudine	Dovato	• Concomitant dofetilide. • Concomitant other antiretrovirals: not recommended. • Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. • May potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). • Avoid concomitant oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. • Antagonized by carbamazepine, rifampin: give additional dolutegravir 50mg separated by 12hrs from Dovato. • Avoid concomitant sorbitol-containing products. • Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/ calcium supplements (also can give together with a meal): give Dovato 2hrs before or 6hrs after.
dolutegravir/ rilpivirine	Juluca	• Concomitant dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, systemic dexamethasone (more than a single dose), St. John’s wort, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole. • Concomitant other HIV-1 antiretroviral therapy: not recommended. • May be affected by drugs that induce or inhibit UGT1A1, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. • May be antagonized by CYP3A inducers; potentiated by CYP3A inhibitors. • Concomitant drugs with a known risk of Torsade de pointes: consider alternatives. • Dolutegravir may potentiate drugs eliminated via OCT2 or MATE1 (eg, dofetilide, dalfampridine, metformin). • Drugs that increase gastric pH may result in decreased plasma concentration. • Concomitant antacids, cation-containing products, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give Juluca 4hrs before or 6hrs after. • Separate H2-receptor antagonists by at least 4hrs before or 12hrs after. • Limit concomitant metformin dose to 1000mg/day; adjust metformin dose when starting or stopping Juluca; monitor closely. • May be potentiated by clarithromycin, erythromycin, telithromycin; consider alternatives (eg, azithromycin). • Concomitant methadone; monitor.
doravirine/ lamivudine/ tenofovir disoproxil fumarate	Delstrigo	• Concomitant strong CYP3A inducers (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John’s wort): discontinue for ≥4wks prior to starting Delstrigo. • May be antagonized by CYP3A inducers (see Contraindications). • May be potentiated by CYP3A inhibitors. • Avoid concomitant or recent use of nephrotoxic agents. • Tenofovir levels increased by ledipasvir/ sofosbuvir, sofosbuvir/ velpatasvir; monitor. • Lamivudine levels decreased by sorbitol; avoid if possible. • Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate lamivudine, tenofovir, (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs).
efavirenz (EVF)/ emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF)	Atripla	• Concomitant voriconazole, elbasvir/ grazoprevir. • Concomitant atazanavir ± ritonavir, posaconazole, boceprevir, simeprevir, sofosbuvir/ velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, glecaprevir/ pibrentasvir, atovaquone/ proguanil, other NNRTIs: not recommended. • Additive CNS effects with alcohol, psychoactive drugs. • Potentiates didanosine levels; monitor closely; discontinue or reduce didanosine dose if toxicity develops. • Concomitant ritonavir: monitor liver function and toxicity. • Tenofovir levels increased by lopinavir/ ritonavir, darunavir + ritonavir, ledipasvir/ sofosbuvir; monitor and discontinue if toxicity occurs. • May antagonize or be antagonized by phenobarbital, phenytoin, carbamazepine (consider alternative), rifabutin (increase dose), rifampin (give additional 200mg/day of efavirenz); monitor. • May antagonize indinavir (may be ineffective, even with increased dose), amprenavir, saquinavir, bupropion, CCBs (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), itraconazole (consider alternative), ketoconazole, lopinavir (adjust dose), maraviroc, methadone (monitor), raltegravir, sertraline, statins, progestins (eg, norelgestromin, levonorgestrel), immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus; monitor). • Avoid concomitant or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs). • Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). • Concomitant drugs with a known risk for Torsade de Pointes (eg, clarithromycin, artemether/ lumefantrine); consider alternatives. • Monitor warfarin. • Efavirenz may cause false (+) urine cannabinoid screening assay.
efavirenz/ lamivudine/ tenofovir disoproxil fumarate	Symfi	• Concomitant elbasvir/grazoprevir. • Avoid concomitant other antiretrovirals, adefovir dipivoxil, atovaquone, posaconazole, boceprevir, pibrentasvir/glecaprevir, proguanil, simeprevir, sorbitol, sofosbuvir/velpatasvir, voxilaprevir. • Additive CNS effects with alcohol, psychoactive drugs. • Caution with drugs metabolized by, or that affect activity of CYP3A, CYP2B6, OCT. • Tenofovir levels increased by ledipasvir/sofosbuvir; monitor. • Antagonized by phenobarbital, carbamazepine, phenytoin, rifampin (give additional 200mg/day). • May antagonize bupropion, CCBs (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil), methadone, rifabutin (increase dose), sertraline, statins, ethinyl estradiol/norgestimate, etonogestrel implant, immunosuppressants (eg, cyclosporine, sirolimus, tacrolimus), itraconazole, ketoconazole (consider alternative antifungals). • Closely monitor warfarin, anticonvulsants (decreased levels of phenytoin, phenobarbital, carbamazepine), rifabutin, immunosuppressants, methadone, others. • Avoid concomitant or recent use of nephrotoxic agents. • Monitor drugs that decrease renal function or compete for renal tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs); consider alternatives to NSAIDs. • Concomitant drugs with a known risk for Torsade de Pointes (eg, clarithromycin, artemether/lumefantrine); consider alternatives. • Efavirenz may cause false (+) cannabis screening test.
efavirenz/ lamivudine/ tenofovir disoproxil fumarate	Symfi Lo
emtricitabine (FTC)/ rilpivirine/ tenofovir alafenamide (TAF)	Odefsey	• Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than a single dose), St. John’s wort. • Concomitant other antiretroviral agents, antimycobacterials (eg, rifabutin): not recommended. • May be potentiated by CYP3A, P-gp and BCRP inhibitors, antagonized by CYP3A or P-gp inducers. • Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. • Concomitant drugs with a known risk for Torsade de Pointes; consider alternatives. • May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). • Separate antacids by ≥2hrs before or 4hrs after rilpivirine; or H2-receptor antagonists by ≥12hrs before or ≥4hrs after rilpivirine; drugs that increase gastric pH may decrease rilpivirine plasma levels. • Monitor for breakthrough fungal infections with concomitant azole antifungals. • Concomitant clarithromycin, erythromycin, telithromycin; consider alternative (eg, azithromycin). • Monitor methadone.
emtricitabine (FTC)/ rilpivirine/ tenofovir disoproxil fumarate (TDF)	Complera	• Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, esomeprazole, dexlansoprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, systemic dexamethasone (more than single dose), St. John’s wort. • Concomitant other antiretroviral agents: not recommended. • Rilpivirine: potentiated by CYP3A inhibitors; antagonized by CYP3A inducers, concomitant rifabutin (see Adults). • Emtricitabine/ tenofovir: may be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). • Tenofovir levels increased by concomitant ledipasvir/ sofosbuvir, sofosbuvir/velpatasvir, sofosbuvir/ velpatasvir/ voxilaprevir; monitor for toxicity. • Concomitant drugs with a known risk for Torsade de Pointes; consider alternatives. • Separate antacids by ≥2hrs before or 4hrs after rilpivirine; or H2-receptor antagonists by ≥12hrs before or ≥4hrs after rilpivirine; drugs that increase gastric pH may decrease rilpivirine plasma levels. • Monitor for breakthrough fungal infections with concomitant azole antifungals. • Concomitant clarithromycin, erythromycin, telithromycin; consider alternative (eg, azithromycin). • Monitor methadone.
elvitegravir/ cobicistat/ emtricitabine (FTC)/ tenofovir alafenamide (AF)	Genvoya	• Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergots, cisapride, St. John’s wort, lomitapide, lovastatin, simvastatin, sildenafil (as Revatio for PAH), triazolam, oral midazolam. • Avoid with concurrent or recent use of nephrotoxic agents. • Not recommended with other antiretroviral agents, rifabutin, rifapentine, rivaroxaban, ticagrelor, or clopidogrel. • Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). • Separate dosing of drugs, antacids, or oral supplements containing polyvalent cations by at least 2hrs. • May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), telithromycin, IV midazolam, diazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), voriconazole, beta-blockers, CCBs, atorvastatin (max 20mg/day), immunosuppressants (monitor), PDE5 inhibitors (see full labeling for dose adjustments), other sedatives/ hypnotics or antipsychotics, quetiapine (consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor), direct oral anticoagulants (see full labeling), tramadol (reduce dose). • Antagonized by oxcarbazepine, corticosteroids (eg, oral dexamethasone, betamethasone, budesonide, fluticasone); consider alternatives. • Concomitant colchicine (see full labeling); not recommended in renal or hepatic impairment. • Concomitant buprenorphine/ naloxone, fentanyl; monitor. • Discontinue bosentan ≥36 hours prior to initiation of Genvoya; resume bosentan after ≥10 days following initiation. • Concomitant salmeterol: not recommended; increased risk of cardiovascular events. • Consider additional or alternative non-hormonal methods of contraception (see full labeling). • Monitor INR with warfarin.
elvitegravir/ cobicistat/ emtricitabine (FTC)/ tenofovir disoproxil fumarate (TDF)	Stribild	• Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergots, cisapride, St. John’s wort, lomitapide, lovastatin, simvastatin, sildenafil (as Revatio for PAH), triazolam, oral midazolam. • Not recommended with other antiretroviral agents, rifabutin, rifapentine, ledipasvir/ sofosbuvir, rivaroxaban, salmeterol. • Avoid with concurrent or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs). • Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, gentamicin). • Separate antacids by at least 2hrs. • May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), clonazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), voriconazole, beta-blockers, CCBs, sofosbuvir/ velpatasvir/ voxilaprevir (monitor), atorvastatin, immunosuppressants (monitor), PDE5 inhibitors (see full labeling for dose adjustments), other sedatives/hypnotics or antipsychotics, quetiapine (reduce dose by ⅙ or consider alternative antiretrovirals), direct oral anticoagulants (see full labeling), tramadol (reduce dose). • Concomitant buprenorphine/ naloxone, fentanyl; monitor. • Antagonized by oxcarbazepine, corticosteroids (eg, oral dexamethasone, betamethasone, budesonide, fluticasone); consider alternatives. • Concomitant colchicine (see full labeling); not recommended in renal or hepatic impairment. • Discontinue use of bosentan at least 36hrs prior to initiation of Stribild; after at least 10 days following initiation, resume bosentan. • Concomitant salmeterol: not recommended; increased risk of cardiovascular events. • Use alternative non-hormonal methods of contraception. • Monitor INR with warfarin.
NOTES
Key: Those listed in bold type* are contraindications. Not an inclusive list of medications and/or contraindications and drug interactions. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 6/2023)