HealthDay News — Americans will continue to be able to get free preventive health care services, at least for now.

The US Court of Appeals for the Fifth Circuit in New Orleans temporarily blocked a lower court decision on Monday, pausing a ruling that challenged an Affordable Care Act (ACA) provision that all health plans cover certain care, The New York Times reported.

The earlier ruling in March, by Judge Reed O’Connor of the Federal District Court for the Northern District of Texas, would have immediately eliminated access to a long list of free preventive services mandated under the ACA since 2010. This was one of the most popular provisions of the ACA and includes depression screening for teens and drugs that prevent HIV transmission for about 150 million Americans enrolled in private employer-sponsored health insurance or through the ACA marketplaces, The Times noted.

O’Connor maintained that the US Preventive Services Task Force, which recommends the list of services, was not appointed by Congress. He ruled that the group did not have the constitutional authority to make a decision about health care services. The USPSTF is an independent group of experts that makes evidence-based recommendations on effective ways to prevent disease and prolong life.

This is not O’Connor’s only ruling on ACA provisions. He ruled in 2018 that the ACA was unconstitutional, a ruling that was later overturned by the US Supreme Court. O’Connor also ruled last September that the ACA mandate requiring coverage of an HIV prevention pill violated a company’s religious freedom, according to the news report.

Americans will keep this free preventive health care while the case works its way through the appeals process. It could end up in the Supreme Court.

The New York Times Article

The pediatric approval was based on data from the phase 2 PAINT study (ClinicalTrials.gov Identifier: NCT00799864), which evaluated the pharmacokinetics, safety, tolerability and efficacy of Edurant and Edurant PED weight-adjusted doses administered once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors. 

Cohort 2 included antiretroviral treatment-naïve HIV-1 infected pediatric patients 6 to less than 12 years of age weighing at least 17kg (n=18). At week 48, findings showed 72% (13/18) of patients had HIV-1 RNA less than 50 copies/mL, while 17% (3/18) had HIV-1 RNA of at least 50 copies/mL. 

The safety and efficacy of Edurant and Edurant PED in treatment-naïve pediatric patients 2 to less than 6 years of age were supported by evidence from adult studies with additional population pharmacokinetic data from pediatric patients 6 years and older.

Due to differing pharmacokinetic profiles, Edurant 25mg film-coated tablets and Edurant PED 2.5mg tablets for oral suspension should not be substituted on a mg-per-mg basis. The recommended dosage in pediatric patients is based on body weight. Both formulations should be taken orally once daily with a meal. Edurant PED must be dispersed in drinking water prior to administration; it should not be chewed or swallowed whole. When a pediatric patient reaches a weight of 25kg or more, they should be switched to Edurant tablets.

“Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their treatment journey,” said Penny Heaton, MD, Global Therapeutic Area Head, Infectious Diseases and Vaccines at Johnson & Johnson. “While the population of young children living with HIV is small, additional treatment options remain key to ensuring that each person living with HIV can be matched to a treatment regimen that is right for them.”

Topical gel approved to treat partial thickness wounds in epidermolysis bullosa; Priority Review given to 21-valent pneumococcal conjugate vaccine; sensory and motor stimuli video game for ADHD gains expanded age approval; on-demand HIV prevention for women; multiple food allergy drug accepted for priority review.

Trogarzo, a CD4-directed post-attachment HIV-1 inhibitor, is indicated in combination with other antiretroviral(s) for the treatment of HIV-1 infection, in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen.

The new approval allows for the 2000mg loading dose to be administered as an IV push rather than a 30-minute IV infusion. The maintenance dose (800mg) of Trogarzo may be administered as a diluted 15-minute IV infusion or an undiluted IV push over a 30-second period every 2 weeks.

“The approved updated label further simplifies the administration of Trogarzo for heavily treated people with HIV, allowing them to initiate treatment within their own clinics,” said Christian Marsolais, PhD, Senior Vice President and Chief Medical Officer at Theratechnologies. “This new administration option for the Trogarzo loading dose is the latest innovation in our ongoing efforts to enhance the convenience of non-oral therapy for this important group of people who have limited treatment options and have been taking oral HIV medication for a long time, many for decades.”

The Company is also finalizing its application with the Food and Drug Administration (FDA) for an intramuscular (IM) formulation of Trogarzo. Results from a phase 3 study showed the mean trough concentrations were comparable between IM injection and IV infusion.