Gilead Presents Phase 2 Data on HIV Treatment - Drug Discovery and Development

HIV-infected H9 T cell. (Credit: NIAID)

Gilead presents new Phase 2 data on bictegravir, an investigational integrase strand transfer inhibitor for the treatment of HIV.

Gilead Sciences, Inc. 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. Bictegravir is a novel investigational once-daily integrase strand transfer inhibitor (INSTI) that is currently in Phase 3 trials as part of a single tablet regimen in combination with FTC/TAF for the treatment of HIV (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). The data are being presented in an oral session (Session O-4) at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

“The high virologic response rates seen in this study show that the pairing of bictegravir with FTC/TAF could potentially offer patients and physicians a new HIV treatment option with pre-clinical data supporting few drug interactions and a high barrier to resistance,” said Paul Sax, M.D., clinical director of infectious diseases at Brigham and Women’s Hospital, professor of medicine at Harvard Medical School and the lead study investigator.

In the study, 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.

“We are pleased with these positive Phase 2 data, which we believe demonstrate that bictegravir in combination with the FTC/TAF backbone potentially represents a potent new treatment option and an important evolution in HIV therapy,” said Norbert Bischofberger, Ph.D., executive vice president, research and development and chief scientific officer, Gilead Sciences. “Based on the data observed in this study, we rapidly advanced the combination of bictegravir and FTC/TAF into four Phase 3 clinical trials. The studies are fully enrolled and we look forward to the availability of these data later this year.”

Bictegravir, including in combination with FTC/TAF as a single tablet regimen, is an investigational treatment that has not been determined to be safe or efficacious.

Further information about the clinical study can be found at www.clinicaltrials.gov.

(Source: Business Wire)