HONG KONG – Taiwan's National Health Insurance Administration has added Gilead Sciences Inc.'s Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide), a once-daily single tablet for the treatment of adults with HIV-1, to its list of reimbursed medicines.

Pongo Peng, general manager for Gilead Taiwan, told BioWorld the move "not only means that treatment is able to reach more patients" but will also enable rapid or same day treatment initiation, helping the nation achieve goals set by the Joint United Nations Programme on HIV and AIDS to help end the HIV epidemic. Those goals are aimed at getting 90% of all people living with HIV to be aware of their HIV status; 90% of all people with diagnosed HIV infection to receive sustained antiretroviral therapy; and 90% of all people receiving antiretroviral therapy to a point of viral suppression.

According to the Taiwan Centers for Disease Control (CDC), there is still some 39,000-people living with HIV in Taiwan, with about 1,992 cases newly diagnosed in 2018. In alignment with the World Health Organization's global goal, the Taiwanese government has set a target to end the HIV epidemic there by 2030. To that end, it has invested in programs that enhance HIV control, including anonymous screening, rapid initiation of treatment and prevention.

Earlier this year, the Taiwan CDC launched "one-stop" rapid HIV testing service together with 12 hospitals. That enables more people to get tested, have their results within an hour and be placed on treatment quickly, if needed.

Peng said Gilead hopes to continuously work with local health authorities, patients, health care professionals and community groups to accelerate progress toward ending the AIDS epidemic.

In addition to Taiwan, Biktarvy is now approved for reimbursement in South Korea, Singapore and Australia. Biktarvy is registered in 53 countries worldwide, including Hong Kong, Singapore, Taiwan and South Korea in Asia.

Based on data from four pivotal studies, it 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 an integrase inhibitor, emtricitabine or tenofovir. In the U.S., it received marketing approval from the FDA in 2018.

"Two of the three drug components, emtricitabine and tenofovir alafenamide, are already part of other first-line therapy regimens recommended by international guidelines, and are known to be safe and well-tolerated by most patients," David Lin, medical affairs director for Gilead Taiwan, told BioWorld. But it is the only single-tablet regimen that contains a novel integrase inhibitor, bictegravir.

According to Lin, clinical studies have shown that Biktarvy has "a high barrier to resistance, few drug-to-drug interactions, and is a once-daily formulation with no food intake requirements." He said those advantages have allowed Biktarvy to quickly become a regimen of choice among HIV health care providers.

"Taiwan's more supportive social and friendlier legislative environment – unlike many in Asia – allows for people who are living with HIV in Taiwan to be more open in getting tested and receiving treatment. The recent legalization of same-sex marriages is a watershed, monumental moment for gay rights and the impact it has for the long-term health care of those within the LGBTQ community affected by HIV," said Peng.

And that open-mindedness is reflected in Taiwan's biotech industry. "A collaborative ecosystem means that getting much-needed therapies or health care to people in need also drives access," he said.

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