The first "injectable" HIV prevention drug approved by the US FDA can reduce AIDS infection by 69% in men and 90% in women.
U.S. FDA announces approval of first injectable drug to prevent HIV infection
The U.S. Food and Drug Administration (FDA) announced on December 20 that it has approved the launch of the injectable drug “Apreude” used to reduce HIV infection. This is currently the world’s first long-acting injectable drug to prevent HIV infection. It is the first new dosage form of pre-exposure prophylaxis (PrEP) besides oral administration.
The FDA statement stated that Apreude is to be used by injection once every month for two consecutive months, and then once every two months. The FDA claims that long-acting injections of pre-exposure prophylaxis will help high-risk groups increase compliance with preventive medication and reduce the risk of HIV infection.
Debra Birnkrant, director of the Division of Antiviral Drugs in the U.S. FDA’s Center for Drug Evaluation, said in a statement that pre-exposure prophylaxis, which is administered once every two months, will be an important weapon in the fight against the HIV epidemic. Particularly for certain at-risk individuals or groups, requiring daily medication compliance is too difficult, and prevention options other than oral medications must be provided.
The current pre-exposure prophylactic medication-PrEP mainly consists of two oral medications (Truvada and Descovy), both of which must be taken every day to achieve the best preventive effect. According to 2020 statistics, about 25% of the U.S. population uses PrEP as a prescription to prevent HIV infection, which is a significant improvement from 3% of the population in 2015. The U.S. government’s goal is to end HIV infection by 2030, and about 50% of the population can obtain significant preventive benefits from PrEP.
90% more effective in preventing the risk of HIV infection. Injectable form has more side effects
Apreude is developed by “ViiV Healthcare”, a subsidiary jointly established by Pfizer and GlaxoSmithKline. Clinical trials in cisgender men (including transgender women) have shown that Apreude is more effective in reducing the risk of HIV infection than taking daily oral pills, with an average risk reduction of 69%. A trial on 3,200 cisgender women found that the injectable form was 90% more effective in preventing HIV than oral medications, and the effect was significant.
However, participants who received Apreude’s preventive drug did experience more side effects than those who took the oral drug, including headaches, fever, fatigue, back pain, muscle pain, rash, and discomfort at the injection site.
It is necessary to confirm that HIV is negative before injection. It is suitable for high-risk groups with poor medication compliance.
The U.S. FDA pointed out that Apreude is currently approved for use in high-risk groups and adolescents weighing more than 35 kilograms. You may choose to start with the oral formulation four weeks before starting injections to see how you tolerate the drug. At the same time, an HIV test must be conducted and confirmed to be negative before injection can be given. And you need to test negative for HIV before each injection to avoid the risk of drug resistance.
Richard Elion, research director of the Washington Institute of Health Research, pointed out that HIV remains a global public crisis, with an estimated 38 million people infected worldwide and 1.7 million new cases every year. PrEP is an important tool to protect people from contracting HIV. In addition to daily oral medications, long-acting injectable medications are now available, which can provide more protective tools for high-risk groups with poor medication compliance.
Pre-exposure prophylaxis is a public health trend for HIV prevention. Since July 2021, the United States has required most domestic insurance companies to cover the cost of oral PrEP drugs. However, Apreude is currently priced at $3,700 per dose and is not yet included in Medicare benefits.
Source: FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention
