A New, Long-Acting HIV Prevention Drug Just Got FDA Approval

The Food and Drug Administration has approved a brand new type of pre-exposure prophylaxis (PReP) for stopping circumstances of HIV. The remedy known as Apretude, and it’s the primary PREP medicine to be taken through injection as a substitute as a once-daily tablet. Apretude will solely should be taken as soon as a month initially, then each two months, probably offering a extra handy possibility for many individuals.

The first PReP remedy, Truvada, was permitted by the FDA in 2012. In 2019, Descovy became the second PReP remedy to be permitted. Both had been developed by Gilead Sciences and depend on a two-drug mixture of present antivirals generally used to deal with HIV. When taken as prescribed, PReP is very efficient at stopping sexually transmitted HIV infections (round 99% efficient), although it’s much less efficient (74%) at stopping infection contracted from sharing contaminated needles.

The rising use of PReP has likely contributed to declining charges of recent HIV infections seen just lately within the U.S., however its implementation has run into stumbles. The brand-name medicine have been comparatively costly, costing over $1,500 per 30 days with out insurance coverage. Until just lately, even PReP customers with insurance coverage nonetheless often faced excessive out-of-pocket prices. And it’s solely this 12 months, following prolonged resistance by Gilead, that different drug producers had been allowed to extensively produce a generic equal to Truvada, which has led to a pointy value drop for the remedy.

Outside of value, the once-daily dosage for PReP introduced a problem, since many individuals eligible for the remedy will not be in a position or keen to take care of their routine. So Apretude might present extra alternatives for PReP for use.

The drug is an extended-release injectable suspension of the HIV antiviral cabotegravir, developed by ViiV Healthcare. It’s been permitted for teenagers and adults who’re thought of to be at larger threat for contracting HIV-1, the first subtype of the virus within the U.S. People beginning on Apretude will take it as soon as a month for the primary two months, after which each two months afterward. Those contemplating Apretude may first take the oral model of cabotegravir for a month, to evaluate its tolerability.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” stated Debra Birnkrant, director of the Division of Antivirals within the FDA’s Center for Drug Evaluation and Research, within the FDA’s announcement of the approval. “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.”

Though Apretude might symbolize an essential step ahead for HIV prevention, it is not going to come cheaply. The listing value of the drug is expected to run round $3,700 per dose, in line with NBC News. Over a 12 months’s time on a six-dose schedule, the drug will value round $22,000 a 12 months, or roughly the identical quantity that Truvada did yearly. Starting this 12 months, nonetheless, many well being protection plans can be required to pay your complete prices of PReP, with none out-of-pocket prices for customers. But excessive listing costs can nonetheless restrict the supply and affordability of a drug, notably for uninsured individuals.