Singapore Health Sciences Authority Approves Biktarvy(R) (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection
In Clinical Trials, Biktarvy Demonstrated High Efficacy and Zero Resistance Through 48 Weeks
SINGAPORE, Feb. 14, 2019 /PRNewswire/ -- Gilead Sciences, Inc. today announced that the Singapore Health Sciences Authority has approved Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults*.
The triple-combination, single tablet regimen combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone - Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF). BIC/FTC/TAF has convenient once-daily dosing, does not require testing for HLA-B 5701, and has no restrictions relative to food, baseline viral load or CD4 count.
The approval was based on data from four studies: Studies 1489 and 1490 in HIV-1 infected adults with no antiretroviral treatment history, and Studies 1844 and 1878 in HIV-1 virologically-suppressed adults who switched to Biktarvy. The trials are comprised of a population of 2,414 participants, and BIC/FTC/TAF met its primary efficacy objective at 48 weeks in all four studies. No participants in the four BIC/FTC/TAF studies developed treatment-emergent virologic resistance. No patients discontinued due to creatinine increases, proximal renal tubulopathy or Fanconi syndrome in the BIC/FTC/TAF arms at 48 weeks. The most common adverse reactions in patients taking BIC/FTC/TAF were diarrhoea, nausea and headache.
"The approval of Biktarvy in Singapore demonstrates Gilead's continued commitment of bringing safe and effective HIV treatments to Asia," said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. "This treatment provides the reassurance of therapy that takes into account long-term health, which can be a concern among patients living with HIV in Singapore."
According to data released by the Ministry of Health, there were 434 new cases of HIV reported among Singaporean residents in 2017. Of these, 71 percent were between the ages of 20-49. Additional ongoing studies not included in the marketing authorization application involve dedicated studies in women, adolescents and children.
BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018, the European Commission on June 21, 2018 and the Hong Kong Department of Health on September 26, 2018.
* BIC/FTC/TAF is a once-daily single tablet regimen (STR) indicated for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
About Gilead Sciences, Inc.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with global headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians may not see the benefits of prescribing BIC/FTC/TAF for the treatment of HIV-1 infection and the possibility of unfavourable results from additional clinical trials involving BIC/FTC/TAF. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, or follow Gilead on Twitter (@GileadSciences).
SOURCE Gilead Sciences, Inc.