The U.S. Food and Drug Administration (FDA) has approved an updated label for Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include additional data supporting its use in pregnant individuals with HIV-1 (PWH) who have suppressed viral loads. This update is based on results from Study 5310, a clinical trial evaluating the pharmacokinetics, safety, and efficacy of Biktarvy in this population.
Study 5310 Details and Findings
Study 5310 was a Phase 1b, open-label, single-arm, multicenter clinical trial that assessed Biktarvy in pregnant PWH who were virologically suppressed (HIV-1 RNA < 50 copies/mL) and had no known resistance to the components of Biktarvy. Participants received Biktarvy once daily from the second or third trimester through the postpartum period. The study's primary objective was to evaluate the pharmacokinetic profile of Biktarvy during pregnancy compared to postpartum.
Lower plasma exposures of Biktarvy were observed during pregnancy compared to postpartum. However, all 32 participants who completed the study maintained viral suppression during pregnancy, at delivery, and through week 18 postpartum. The median CD4+ cell count at baseline was 558 cells/µL, with a median increase of 159 cells/µL from baseline to week 12 postpartum. All 29 newborn participants had negative or undetectable HIV-1 PCR results at birth and/or at four to eight weeks post-birth.
The study found no new safety or tolerability concerns for individuals using Biktarvy during pregnancy and postpartum. The overall incidence and types of adverse events were consistent with those expected for the studied population.
Clinical Implications and Guidelines
With this label update, Biktarvy becomes the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval for virologically suppressed adults who are pregnant. The U.S. Department of Health and Human Services (DHHS) perinatal guidelines now recognize Biktarvy as an alternative complete regimen for use in pregnancy and for individuals who are trying to conceive. The guidelines also recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
"This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH, an often understudied and most vulnerable community in clinical research," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant."
Biktarvy: Overview and Safety Information
Biktarvy is a complete HIV treatment that combines three medicines: bictegravir, emtricitabine, and tenofovir alafenamide. It is administered as a single-tablet regimen once daily, with or without food. Biktarvy has a high barrier to resistance and limited drug interaction potential.
The Biktarvy label includes a boxed warning regarding post-treatment acute exacerbation of hepatitis B in patients co-infected with HIV-1 and HBV who discontinue products containing emtricitabine and/or tenofovir disoproxil fumarate. The label also advises monitoring hepatic function closely in these patients and considering anti-hepatitis B therapy if appropriate.
Other warnings and precautions include potential drug interactions, immune reconstitution syndrome, new onset or worsening renal impairment, lactic acidosis, and severe hepatomegaly with steatosis. Common adverse reactions include diarrhea, nausea, and headache.
Commitment to HIV Treatment
Gilead Sciences has been a leading innovator in the field of HIV for 35 years, developing 12 HIV medications, including single-tablet regimens, pre-exposure prophylaxis (PrEP), and long-acting injectable treatments. The company remains committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV.
