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Singapore HSA Approves HIV-1 Infection Treatment for Adults

In clinical trials, biktarvy demonstrated high efficacy and zero resistance through 48 weeks.

The Singapore Health Sciences Authority has approved Gilead Sciences’ Biktarvy, a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults.

It is a triple combination regimen, combining bictegravir 50mg, emtricitabine 200 mg and tenofovir alafenamide 25 mg; BIC/FTC/TAF. It is 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.

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.

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 to 49.

BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on 7 February 2018, the European Commission on 21 June 2018 and the Hong Kong Department of Health on 6 September 2018. [APBN]