Apretude becomes first FDA approved injectable pre-exposure prophylaxis (PrEP) medication for HIV prevention.
On Monday, December 20th, the U.S. Food and Drug Administration (FDA) gave its approval to Apretude for HIV prevention. The cabotegravir extended-release injectable suspension is meant to be an alternative to daily oral pills for pre-exposure prophylaxis (PrEP). FDA’s approval will make the medication available to adults and adolescents weighing at least 35kg, and at risk of sexually acquiring HIV. According to FDA’s statement, two initiation injections, a month apart, are first administered. Then, a single injection is given every two months.
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.
Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research
Cabotegravir is an integrase strand transfer inhibitor (INSTI). It prevents viral DNA from integrating into the genetic material of T-cells; thus, inhibiting viral replication. This is an important step in HIV replication and is also responsible for the development of chronic diseases in patients. Prior to starting the medication and prior to each injection, one must test negative for HIV. Moreover, if patients need to see how well they tolerate the injections, they can take oral cabotegravir pills (Vocabria) daily for four weeks.
Injectable Better Than Oral
FDA’s approval is based on results from two trials that compared the effectiveness of Apretude to a once-daily oral pill, Truvada. The first trial included 4,600 cisgender men and transgender women who have sex with men. Those who took the injectable medication had a 69% lower risk of contracting HIV than those on the oral pills.
Another trial recruited 3,200 cisgender women at risk of HIV infection. According to the results, women in the injectable group had an 89% lower risk of HIV infection than those who took Truvada. Furthermore, the oral pill group reported greater side effects such as fever, muscle pain, rash, back pain, and reaction at the injection site.
Pre-exposure prophylaxis medications are important in preventing HIV. However, adherence to daily medication is significantly low in certain high-risk individuals and groups. External factors such as poverty and depression further impact one’s adherence. Therefore, FDA hopes that the availability of an injectable HIV prevention option will increase compliance among people. Moreover, it can help decrease the incidence of HIV in the United States.
Due to the risk of drug-resistant HIV variants, people are only advised Apretude on a negative HIV test. However, if they become infected while on the injection then they must switch to an HIV treatment regimen,
Source: FDA
