The Food and Drug Administration has approved a combination drug intended to treat HIV-1 infections – bictegravir, emtricitabine, tenofovir alafenamide – in virologically suppressed (HIV-1 RNA less than 50 copies/mL) adults who have no history of antiretroviral treatment or as a replacement for their current antiretroviral regimen.
The approval of the new combination drug () was based on four active, randomized, controlled trials comprising three double-blind studies and one open label study. After 48 weeks of treatment in all trials, CD4+ cell count was evaluated to determine the efficacy of bictegravir, emtricitabine, tenofovir alafenamide, compared with other antiretroviral therapies.
In trial 1489, patients were randomized 1:1 to receive Biktarvy (n = 314) or ABC/DTG/3TC (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) (n = 315). Trial 1490 was similar to trial 1489, with patients randomized 1:1 to receive either Biktarvy (n = 320) or DTG + FTC/TAF (dolutegravir + 50 mg, emtricitabine 200 mg/tenofovir alafenamide fumarate 25 mg) (n = 325). In trial 1489, the mean increase in CD4+ count after 48 weeks was 233 cells per mm3 and 229/mm3 in the Biktarvy and ABC/DTG/3TC groups, respectively. Similarly, counts in trial 1490 CD4+ after 48 weeks were 180/mm3 and 201/mm3 in the Biktarvy and DTG + FTC/TAF groups, respectively.
Trial 1844, another randomized trial, was composed of patients who switched to Biktarvy from their older treatment. Patients were randomized 1:1 to the new treatment (n = 282) or their previous antiretroviral regimen (n = 281).
Over 48 weeks, the mean change in CD4+ cell count was –31 cells per mm3 in subjects who switched to Biktarvy and 4/mm3 in subjects who stayed on ABC/DTG/3TC.
The open-label portion of the study, trial 1878, evaluated the safety and efficacy of switching from other retroviral treatments (n = 287) to Biktarvy (n = 290). The average change in CD4+ count after 48 weeks was 25 cells per mm3 who switched to Biktarvy and 0/mm3 who stayed on their previous regimens.
The new combination has received aregarding the risk of severe acute exacerbations of hepatitis B that have been reported in patients coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of Biktarvy. Such patients should be closely monitored for hepatic function with both clinical and laboratory follow-up for at least several months in patients if they discontinue Biktarvy. If appropriate, antihepatitis B therapy may be warranted.
The approved recommended dosage for bictegravir, emtricitabine, tenofovir alafenamide combination drug is one tablet daily with or without food. More information is available on the.