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Delstrigo Generic Name & Formulations
Legal Class
Rx
General Description
Doravirine 100mg, lamivudine 300mg, tenofovir disoproxil fumarate 300mg; tabs.
Pharmacological Class
Non-nucleoside reverse transcriptase inhibitor + reverse transcriptase inhibitors (nucleoside + nucleotide analogue).
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Delstrigo Indications
Indications
As a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve patients, or to replace the current antiretroviral regimen in virologically suppressed (HIV-1 RNA <50copies/mL) patients on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Delstrigo.
Delstrigo Dosage and Administration
Adult
Test for HBV infection prior to initiation. ≥18yrs: 1 tab once daily. Concomitant rifabutin: give additional doravirine 100mg approx. 12hrs after Delstrigo dose.
Children
<18yrs: not established.
Delstrigo Contraindications
Contraindications
Concomitant strong CYP3A inducers (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, enzalutamide, rifampin, rifapentine, mitotane, St. John's wort): discontinue for ≥4wks prior to starting Delstrigo.
Delstrigo Boxed Warnings
Boxed Warning
Post-treatment acute exacerbation of hepatitis B.
Delstrigo Warnings/Precautions
Warnings/Precautions
Test for HBV before starting antiretroviral therapy. Discontinuation of lamivudine and/or tenofovir disoproxil may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). New onset or worsening renal impairment. Assess SCr, estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) before initiating and during therapy; discontinue if significant renal dysfunction or Fanconi syndrome develops. History of pathologic fracture or risk factors for osteoporosis or bone loss: consider monitoring bone mineral density (BMD); calcium/vitamin D supplement may be beneficial. Renal impairment (CrCl<50mL/min): not recommended. Severe hepatic impairment (Child-Pugh C): not studied. Elderly. Pregnancy. Nursing mothers: not recommended.
Delstrigo Pharmacokinetics
See Literature
Delstrigo Interactions
Interactions
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).
Delstrigo Adverse Reactions
Adverse Reactions
Dizziness, nausea, abnormal dreams, insomnia, diarrhea, somnolence, rash; decreased BMD, immune reconstitution syndrome.
Delstrigo Clinical Trials
See Literature
Delstrigo Note
Notes
To register pregnant patients to the Antiretroviral Pregnancy Registry, call (800) 258–4263.
Delstrigo Patient Counseling
See Literature
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