FOSTER CITY (dpa-AFX) - Gilead Sciences, Inc. (GILD) announced 48 week results from a Phase 2 study evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide TAF for the treatment of HIV-1 infection.
The company said that at 48 weeks, a regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg was found to be similar to Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) based on the percentage of patients with HIV RNA levels less than 50 copies/mL, and was associated with more favorable renal and bone safety markers.
'These results suggest that TAF has the potential to be an important advance for people living with HIV,' said Paul Sax, MD, Clinical Director of the Division of Infectious Diseases at Brigham and Women's Hospital, Boston, Professor of Medicine at Harvard Medical School, and an investigator for Study 102.
The company noted that in Study 102, 170 HIV-positive treatment-naïve adult patients were randomized to receive the investigational TAF-based regimen or Stribild. At 48 weeks, 88.4 percent of patients taking TAF and 87.9 percent of patients taking Stribild achieved HIV RNA less than 50 copies/mL, based on the FDA snapshot algorithm. No drug resistance was observed in patients receiving the TAF-based regimen.
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