Gilead Sciences’ Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets) has been approved by the US Food and Drug Administration (FDA) for expanded human immunodeficiency virus (HIV) use.
The drug is now authorised to treat HIV in patients with an antiretroviral treatment history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor class, emtricitabine or tenofovir.
An estimated 1.2 million people in the US are currently living with HIV, a virus that weakens the immune system and increases the risk of serious illness.
Taken orally once daily, Biktarvy is a complete HIV treatment that combines three medicines in a single pill and reduces the amount of HIV in the blood to undetectable levels. It is already approved for a range of HIV-1 patient populations.
The new indication will help address a “critical unmet need”, Gilead said, as currently only 65% of HIV patients are estimated to be virally suppressed at any point in time, and many interrupt and later need to restart treatment.
The FDA’s latest decision was supported by the “strength of evidence” for Biktarvy from two treatment naïve studies, the company outlined.
The drug was associated with rapid and durable viral suppression, and demonstrated an established long-term safety and tolerability profile, and zero cases of treatment-emergent resistance to Biktarvy over five years.
Jared Baeten, senior vice president, virology therapeutic area head, Gilead, said: “Continuous scientific discoveries and person-centric advances in HIV care have helped transform the treatment landscape. At the same time, not everyone is achieving long-term HIV treatment success, especially when someone experiences an interruption in their HIV care.
“With this new indication, Biktarvy can now support an even broader range of people with HIV in reaching their long-term treatment goals, including those who are not virologically suppressed and who are restarting treatment.”
HIV is a key focus area for Gilead, with the authorisation coming less than two months after the company’s twice-yearly injectable pre-exposure prophylaxis (PrEP) drug received FDA approval to prevent HIV.
Yeztugo (lenacapavir), which was authorised to reduce the risk of sexually-acquired HIV in adults and adolescents weighing at least 35kg, is now the first PrEP option in the US that offers six months of protection against the virus.