FDA Approves First HIV Prevention Injection

(PatrioticPost.com)- The FDA has approved the first injectable HIV pre-exposure prophylaxis that will help at-risk individuals avoid sexually-transmitted HIV without having to take a daily pill.

The new drug, Apretude is an injectable given every two months and is an alternative to HIV pre-exposure prophylaxis pills, like Truvada and Descovy, which have been shown to reduce the risk of HIV by 99 percent when taken daily.

Two trials for Apretude, conducted in thirteen countries show that the injectable was more effective at preventing HIV infection than the pill Truvada. In one trial, participants were 69 percent less at risk of getting infected with HIV than those taking the oral medication. In the other study, participants taking Apretude and cabotegravir were 90 percent less at risk than those taking Travuda.

Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research said the approval of Apretude provides an important tool in the ongoing effort to end the HIV epidemic by providing the first pre-exposure prophylaxis that does not require taking a daily dose.

Since the injection only needs to be administered every two months, the FDA is hopeful the option of an injectable drug will improve uptake among those in high-risk groups, such as younger gay men who are less likely to keep up with taking a daily pill.

According to the Centers for Disease Control and Prevention, gay men still make up the majority of new HIV cases. Last year, only one-quarter of the 1.2 million people eligible for pre-exposure prophylaxis pills received prescriptions.

In July, the federal government announced that almost all health insurance providers must cover the full cost of the two FDA-approved pre-exposure prophylaxis pills as well as the lab tests and clinic visits required while taking the medication. At present, insurers are not required to cover all costs for Apretude which is listed at $3,700 per dose.

GlaxoSmithKline’s ViiV Healthcare will begin shipping Apretude to US distributors early next year. So far, the United States is the only jurisdiction to have approved Apretude.