Gilead HIV drug Biktarvy shows sustained efficacy in long term data
Justin Sullivan

Gilead Sciences (NASDAQ:GILD) reported real-world data from a study called BICSTaR and new five-year data from two phase 3 trials of HIV therapy Biktarvy.
The real-world data was presented from the 24-month BICSTaR follow-up analysis of Biktarvy across nine countries. Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) was generally well tolerated and showed efficacy regardless of prior treatment and comorbidity status in people with HIV, the company said in a press release on Monday
People on Biktarvy experienced high viral suppression. Overall, 97% (104/107) of people of who had not received prior treatment and 95% (497/521) of treatment-experienced participants achieved viral suppression at two years.
Gilead noted that treatment discontinuations (14% overall) were low, and few people (7%) discontinued Biktarvy due to drug-related AEs (DRAEs). The most common DRAEs were weight change (3%) and depression (1%).
Phase 3 trials: (Study 1489 and Study 1490)
The company said data showed long-term safety and efficacy of Biktarvy in those who switch from a dolutegravir-containing regimen. Dolutegravir is developed by ViiV Healthcare, which is majority-owned by GSK (GSK) and counts Pfizer (PFE) and Shionogi Limited (OTCPK:SGIOF) (OTCPK:SGIOY) among its shareholders.
Gilead added that data showed Biktarvy to have high efficacy and sustained safety for people switching to the drug, with a continued high barrier to resistance. These outcomes were seen in people 96 weeks after switching to open-label Biktarvy following 144 weeks of blinded dolutegravir + 2 NRTIs.
At week 240, more than 99% of people in both Study 1489 (217/218; missing=excluded) and Study 1490 (232/234; missing=excluded) achieved viral suppression, according to the company.
In addition, Gilead said that at every visit through 240 weeks, data showed that following the switch to Biktarvy, efficacy was >96% (missing=excluded), suggesting that the medicine may provide sustained viral suppression for people with HIV, even after switching treatments.
Gilead noted that 0.4% (2/519) of switch participants in both studies experienced an AE which led to drug discontinuation in the open-label extension period.