FDA Clears Gilead’s Bixlenvo as Once-Daily HIV Treatment With $4,595 Price Tag
Synopsis
Gilead Sciences said the FDA approved its oral combination pill Bixlenvo for adults with suppressed HIV, bringing bictegravir and lenacapavir into a once-daily treatment; the drug will carry a $4,595 wholesale cost for a 30-day supply.
The US FDA has approved Gilead Sciences’ once-daily oral combination pill Bixlenvo for adults with HIV whose infection is already suppressed to very low levels, the company said on Thursday.
Bixlenvo combines two of Gilead’s HIV medicines, bictegravir and lenacapavir. The pill is designed to offer a simpler treatment option for patients who may otherwise require more complex drug regimens.
The company expects the treatment to become available within days of the approval.
The pill has a wholesale acquisition cost of $4,595 for a 30-day supply, according to a Gilead spokesperson.
New Option for Patients with Treatment Complexity
Bictegravir is the key component of Gilead’s widely used Biktarvy treatment and is known for having a high barrier to HIV drug resistance. Lenacapavir, meanwhile, is a capsid inhibitor that targets the protective shell surrounding HIV and interferes with the virus’s ability to multiply.
Patients beginning Bixlenvo must first receive an initial two-day dose of Sunlenca before moving to the once-daily pill.
Monika Shah, an infectious disease specialist at Memorial Sloan Kettering Cancer Center, said the combination could reduce the pill burden for patients who have a history of drug-resistant HIV and currently rely on more complicated treatment regimens.
The FDA approval was supported by two late-stage studies. In those trials, Bixlenvo was shown to be as effective as complex multi-pill regimens or Biktarvy at maintaining viral suppression after 48 weeks.
Gilead Expands HIV Drug Portfolio
Gilead is positioning lenacapavir as a central component of its longer-term HIV strategy. The drug is already marketed as Sunlenca for HIV treatment and as Yeztugo for HIV prevention.
According to Jared Baeten, Gilead’s head of clinical development for virology, around 5% of people living with HIV in the US take treatment regimens requiring more than one tablet a day.
Bixlenvo enters an increasingly competitive HIV treatment market. Merck’s Idvynso, another once-daily two-drug pill, was approved in April for certain adults whose HIV-1 infection is already suppressed.
HIV attacks the immune system and can progress to AIDS without treatment. While there is currently no cure, effective medicines can suppress the virus and help people live longer, healthier lives.
Source: Reuters
Vishal is an experienced Editor at Inspirepreneur Magazine with key interests in artificial intelligence, eCommerce, entrepreneurship, lifestyle and startup sector. Prior to joining Inspirepreneur, he was a Content Writer cum Correspondent at Siliconindia Magazine, where he worked on Company Profiles, Cover Stories, Executive Profiles, Feature Articles and Thought Leadership content.
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