Approval of HIV medication by Taiwan National Health Insurance Administration sets Taiwan on track for the 90-90-90 targets set by UNAIDS.
Biktarvy® is a once-daily single table regiment or the treatment of HIV-1 infection in adults. It is a combination of 3 HIV medications, 50 milligrams of bictegravir, 200 milligrams of emtricitabine and 25 milligrams of tenofovir alafenamide.
According to the Centers for Disease Control, there are more than 39,000 people living with HIV in Taiwan as of August 2019. Taiwan is on track to achieve the UNAIDS 90-90-90 goals to help end the HIV epidemic — 90 percent of all people living with HIV will know their HIV status; 90 percent of all people with diagnosed HIV infection will receive sustained antiretroviral therapy; and 90 percent of all people receiving antiretroviral therapy will have viral suppression.
“Taiwan has made significant progress toward the 90-90-90 targets set by UNAIDS,” said Pongo Peng, General Manager, Gilead Taiwan. “The reimbursement of Biktarvy will expand patient access to an innovative treatment for a broad range of patients, and support Taiwan’s goal of treating the disease and helping to end HIV epidemic in Taiwan by 2030.”
Biktarvy® was approved by the Taiwan Food and Drug Administration in January 2019 for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to integrase inhibitor class, emtricitabine or tenofovir. The approval was based on data from four pivotal 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 Biktarvy® met its primary efficacy objective at 48 weeks in all four studies, with no participants in any of the four Biktarvy® studies developing treatment-emergent virologic resistance. There were no cases of renal discontinuation, proximal renal tubulopathy or Fanconi syndrome in the Biktarvy® arms at 48 weeks. The most common adverse reactions in patients taking Biktarvy® were diarrhoea, nausea, and headache.
Biktarvy® received marketing approval from the U.S. Food and Drug Administration (FDA) in 2018. [APBN]