Biktarvy® Demonstrates High Efficacy for a Broad Range of People Initiating Treatment for HIV, Including Those With HBV Coinfection

Gilead Sciences, Inc. (Nasdaq: GILD) today announced results reinforcing Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a highly efficacious treatment option for a broad range of people with HIV, including individuals with HIV/hepatitis B (HBV) coinfection. Interim data from the ALLIANCE trial evaluating Biktarvy in adults with HIV/HBV coinfection who were initiating therapy show potential suppression of HBV and HIV suppression comparable to an alternative HIV regimen. Additionally, 5-year data from two Phase 3 trials further demonstrated Biktarvy’s sustained efficacy, safety profile and high barrier to resistance in adults with HIV initiating therapy. The data were presented at the 24th International AIDS Conference (AIDS 2022).

Data from the ALLIANCE trial, which is an ongoing Phase 3 trial evaluating Biktarvy versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, demonstrated the efficacy of both antiretroviral regimens, in adults with HIV/HBV co-infection initiating treatment. The Week 48 results show Biktarvy demonstrated superior HBV DNA suppression. Importantly, participants who initiated treatment with Biktarvy versus DTG+F/TDF demonstrated superior HBV DNA suppression (<29 IU/mL) (63% vs. 43%, p=0.0023) and hepatitis B e-antigen (HBeAg) seroconversion (23% vs. 11%, p=0.031). The Week 48 results also showed that participants who initiated treatment with Biktarvy or DTG+F/TDF both had similarly high rates of HIV suppression (HIV-1 RNA <50 copies/ml). Participants who initiated treatment with Biktarvy or DTG+F/TDF both had high rates of HIV suppression at Week 48 (95% vs. 91%; 95% CI – 2.5% to 10.8%, p=0.21) with mean CD4 cell count increases of 200 and 175 cells/μl from baseline, respectively.

HIV/HBV coinfection is a major global public health threat that increases the morbidity and mortality beyond either infection alone. HBV impacts approximately 8% of people with HIV globally, and HIV/HBV coinfection rates can reach 25% in areas where both viruses are endemic, such as Asia. In some parts of Asia, HBV is endemic with a projected 70% of the population showing serologic evidence of current or prior infection. Because each virus affects the other’s natural history and response to therapy, HIV/HBV co-infection requires dedicated research.

“ALLIANCE is a landmark clinical trial, investigating the specific treatment responses of adults with HIV/HBV co-infection,” said Anchalee Avihingsanon, MD, PhD, Senior Researcher, HIV–NAT, Thai Red Cross AIDS Research Center, Thailand. “Emerging HIV epidemics in areas of high HBV rates such as Asia are expanding the number of people with HIV/HBV coinfection. This inclusive and representative study enrolled and treated participants from 11 different geographies with 88% of participants of Asian descent, driving the availability of data from within those communities most impacted.”

About ALLIANCE (NCT03547908)

ALLIANCE is a Phase 3, randomized, double-blind study designed to evaluate the safety and efficacy of Biktarvy or DTG+F/TDF (with placebo) in adults initiating treatment for HIV/hepatitis B (HBV) co-infection. The primary endpoints evaluated the proportion of adults with HIV-1 RNA suppression (<50 copies/mL) and proportion of adults with plasma HBV DNA suppression (<29 IU/mL) at Week 48. Secondary endpoints will include efficacy of Biktarvy versus DTG+F/TDF by achievement of HIV-1 RNA suppression (<50 copies/mL), HBV DNA suppression (< 29 IU/mL), and the safety and tolerability of the two treatment groups at Week 96.

About Studies 1489 and 1490

Study 1489 and Study 1490 are Phase 3, randomized, double-blind, active-controlled studies. For 144 weeks, treatment-naïve participants were blinded to receive either Biktarvy (n=634) or a dolutegravir-containing triple therapy (n=640). The primary endpoint was the proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm. Secondary endpoints included efficacy, safety, and tolerability assessed through Weeks 96 and 144. Beyond week 144, participants were able to receive Biktarvy in an active open-label extension phase for up to 96 weeks.

About Biktarvy

Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines.
About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications, including the first single-tablet regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people impacted by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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