GSKs long-acting HIV shot approved for preventive use

The Food and Drug Administration has, for the first time, approved a long-acting, injectable medicine to protect against HIV in adults and adolescents considered at risk of contracting the virus. Developed by ViiV Healthcare, Apretude is initially given as two shots one month apart, and then every two months thereafter. It contains cabotegravir, an antiviral agent and the active ingredient in Cabenuva and Vocabria, which are, respectively, injectable and oral drugs used to keep existing HIV infections in check. British pharmaceutical giant GlaxoSmithKline is the majority owner of ViiV, and records sales of its marketed products. In a statement, Debra Birnkrant, director of the antivirals division in the FDA's main drug review office, called Apretude an "important tool in the effort to end the HIV epidemic." While the use of pre-exposure prophylaxis, or PrEP, has grown, many people at high risk of HIV infection still don't receive it. In the U.S., just about 25% of the 1.2 million people whom PrEP is recommended for were prescribed it last year, according to the Centers for Disease Control and Prevention.Great strides have been in the treatment of HIV and AIDS. Twenty years ago, patients needed fistfuls of medications to keep their infections under control. Now, a single daily pill can be just as effective. HIV is still an epidemic, though, and no cure yet exists for the disease. In 2019 alone there were at least 36,000 new diagnoses in the U.S. and its territories, pushing the total number of patients to nearly 1.2 million. Among that population, the CDC estimates about 87% knew they had HIV. Preventive treatments have proven essential in the ongoing fight against the disease. In 2012, Gilead's once-daily pill Truvada became the first drug approved by the FDA to reduce the risk of sexually acquired HIV in unaffected adults. The agency then cleared a second drug, Gilead's Descovy, as a PrEP treatment in late 2019. Apretude now provides HIV patients in the U.S. a third and, importantly, long-acting option. Healthcare experts note that many patients have a difficult time adhering to daily PrEP regimens. "This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option," Birnkrant of the FDA said in the agency's Monday statement announcing Apretude's approval. But adherence is just one of the challenges facing HIV patients. For many, accessing treatment continues to be difficult due to a combination of drug costs, insurance policies, stigma and lack of awareness about the disease. Access has especially limited in Black and Latino populations, two groups unevenly affected by HIV. ViiV's CEO Deborah Waterhouse notes that Apretude was studied in "one of the most diverse and comprehensive HIV prevention trial programs to date," with "some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial." With approval in hand, Waterhouse said the hope is that ViiV's shot can be a valuable option for these populations. "People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills," she said in a statement. A spokesperson for GSK confirmed that the WAC, or wholesale acquisition cost, for Apretude is $3,700. Given that Apretude is mostly dosed every two months, its cost would be almost the same as or less than the monthly WACs of branded, oral PrEP drugs that are used daily, according to the spokesperson The FDA's decision to approve Apretude was based on two large clinical trials. One tested the drug against Truvada in nearly 4,600 cisgender men and transgender women who have sex with men, and found that patients on Apretude were 69% less likely to be infected with HIV. The other trial evaluated more than 3,200 cisgender women, and found the risk of HIV infection was 90% less in those given Apretude versus a Truvada regimen.

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