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Gilead's Biktarvy Shows High Efficacy For Broad Range Of People Initiating Treatment For HIV

Gilead Sciences Inc.'s (GILD) Biktarvy demonstrated high efficacy for a broad range of people initiating treatment for HIV, including those with hepatitis B or HBV coinfection, as per ALLIANCE trial results.

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.

Interim data from the ALLIANCE trial evaluating Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in adults with HIV/HBV coinfection who were initiating therapy showed potential suppression of HBV and HIV suppression comparable to an alternative HIV regimen.

In addition, 5-year data from two phase 3 trials also demonstrated Biktarvy's sustained efficacy, safety profile and high barrier to resistance in adults with HIV initiating therapy.

Data from the ALLIANCE trial, which is an ongoing Phase 3 trial evaluating Biktarvy versus dolutegravir 50 mg or 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. Participants who initiated treatment with Biktarvy versus DTG+F/TDF demonstrated superior HBV DNA suppression and hepatitis B e-antigen (HBeAg) seroconversion.

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. Participants who initiated treatment with Biktarvy or DTG+F/TDF both had high rates of HIV suppression at Week 48 with mean CD4 cell count increases of 200 and 175 cells/µl from baseline, respectively.

The ALLIANCE trial will continue in a blinded fashion through Week 96 to determine longer-term safety and efficacy.

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