Date: 2017-02-13
Type of
information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the Conference on Retroviruses and Opportunistic Infections (CROI)
Company: Gilead Sciences (USA - CA)
Product: bictegravir (GS-9883)
Action
mechanism:
- integrase inhibitor. Bictegravir is a HIV-1 integrase strand transfer inhibitor (INSTI).
Disease: HIV-1 Infection
Therapeutic
area: Infectious diseases
Country: USA
Trial
details:
- This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) + emtricitabine/tenofovir alafenamide (FTC/TAF) fixed dose combination (FDC) versus dolutegravir (DTG) + FTC/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also evaluate the pharmacokinetic (PK) profile of BIC, FTC and TAF. (NCT02397694)
Latest
news:
- • On February 13, 2017, Gilead Sciences announced data from a Phase 2 study evaluating the efficacy, safety and tolerability of a combination of bictegravir (75 mg) (BIC) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) versus dolutegravir (50 mg) (DTG) and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) in treatment naïve, HIV-1 infected adults. Results found that the BIC+FTC/TAF and DTG+FTC/TAF regimens both demonstrated high virologic response rates at Week 24 and Week 48. The data are being presented in an oral session (Session O-4) at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.
- In the study, 98 treatment naïve, HIV-infected adults were randomized 2:1 in a blinded fashion to receive either BIC+FTC/TAF (n=65) or DTG+FTC/TAF (n=33). The once-daily treatments were administered without regard for food for 48 weeks. At Week 24, 97 percent (n=63/65) of patients taking BIC+FTC/TAF and 94 percent (n=31/33; 95 percent CI: -8.5 percent to 14.2 percent, p=0.50) of patients taking DTG+FTC/TAF achieved HIV-1 RNA levels less than 50 copies/mL. At Week 48, 97 percent (n=63/65) of patients taking BIC+FTC/TAF and 91 percent (n=30/33; 95 percent CI: -6.0 percent to 18.8 percent, p=0.17) of patients taking DTG+FTC/TAF achieved HIV-1 RNA levels less than 50 copies/mL. No viral resistance was detected in the BIC+FTC/TAF arm. Mean CD4 count increases at Week 48 were 258 cells/µL in the BIC+FTC/TAF arm and 192 cells/µL in the DTG+FTC/TAF arm. One subject in the BIC+FTC/TAF arm discontinued due to an adverse event of urticaria following the Week 24 visit. Median changes in estimated glomerular filtration by Cockcroft-Gault (GFRCG) at Week 48 were -7.0 mL/min for BIC+FTC/TAF and -11.3 mL/min for DTG+FTC/TAF, with no discontinuations due to renal adverse events. There were no treatment-related serious adverse events and no deaths in either arm, and the most commonly reported adverse events were diarrhea and nausea.
Is
general: Yes
