Approval of New HIV Treatment Combination by FDA

Overview of the Approval

The FDA has granted approval for the combination of bictegravir and lenacapavir, termed Bixlenvo, aimed at adults with virologically suppressed HIV-1 infection, as announced by Gilead Sciences.

This combination pill, taken once daily, contains 75 mg of bictegravir, an integrase strand transfer inhibitor (INSTI), and 50 mg of lenacapavir, a capsid inhibitor. It is approved for adults maintaining HIV-1 RNA levels below 50 copies per mL who are transitioning from a stable antiretroviral regimen without resistance to these medications.

Significance of the Approval

Chloe Orkin, MBBCH, MSc, from Queen Mary University of London, remarked on the significance of this advancement, stating it enables individuals who can’t benefit from conventional single-tablet regimens—due to issues like existing resistance or tolerability—to access a more tailored treatment option.

Clinical Trials Supporting the Approval

The FDA’s decision was backed by results from two pivotal phase III clinical trials, ARTISTRY-1 and ARTISTRY-2. ARTISTRY-1 included 557 participants with suppressed HIV on complex oral regimens. Among those who switched to the new combination, only 0.8% showed HIV-1 RNA levels above 50 copies per mL after 48 weeks, compared to 1.1% who continued their previous regimen. No resistance was noted for the two drugs in the combination post-treatment, and adverse events were similar in both groups.

In ARTISTRY-2, the bictegravir-lenacapavir pill proved to be noninferior to the established regimen of bictegravir, emtricitabine, and tenofovir alafenamide (Biktarvy). After the same 48 weeks, 1.3% of those switching to bictegravir-lenacapavir had detectable HIV-1 RNA compared to 1.0% who remained on the three-drug regimen. Adverse events were comparable, with no significant drug-related issues recorded.

Dosing Information

The approved regimen commences with a 2-day initiation period involving one tablet of bictegravir-lenacapavir and two 300-mg tablets of lenacapavir (Sunlenca), followed by a maintenance dose of one tablet of bictegravir-lenacapavir daily. The medication can be taken with or without food. Notably, the prescribing information advises against concurrent use with dofetilide or strong CYP3A inducers and other antiretroviral treatments for HIV-1.

Common Side Effects

The most frequently reported adverse reactions include headache, nausea, and diarrhea.

Future Investigations

Oral lenacapavir is being researched as part of other treatment combinations for suppressed HIV. Recent phase III trials presented at the International AIDS Conference in Rio de Janeiro indicate that weekly oral lenacapavir with islatravir matches the efficacy of conventional daily standard-of-care regimens.

Disclaimer: This information is not intended as medical advice and should not replace consultation with a qualified healthcare professional.

Fuente: https://www.medpagetoday.com/infectiousdisease/hivaids/122817

Fuente primaria: Gilead Sciences — FDA approval of Bixlenvo (bictegravir/lenacapavir), based on the ARTISTRY-1 (NCT05502341) and ARTISTRY-2 (NCT06333808) trials