FDA Approves Twice-Yearly HIV Prevention Injection

New drug offers significant protection against HIV transmission, but at a high cost

The Food and Drug Administration has greenlit a groundbreaking injectable medication to ward off HIV, marking a potential turning point in combating the virus. This innovative preventative measure, administered twice a year, offers a new option for those seeking to protect themselves against HIV.

Groundbreaking Prevention

The FDA has approved a twice-yearly injection from Gilead Sciences to prevent HIV, according to reports. This breakthrough, as described by the company, represents a major advancement in the fight against this sexually transmitted virus that causes AIDS. The medication, named YEZTUGO, was developed by a scientific team led by the Czech virologist and biochemist Tomáš Cihlář.

YEZTUGO lowers the risk of HIV transmission for adults and adolescents by over 99.9 percent. It’s engineered to function much like a very effective vaccine, reports noted. Gilead Sciences conducted two large-scale clinical trials. The initial study, involving more than 2,000 women in Sub-Saharan Africa, resulted in a complete reduction in infections, outperforming the daily Truvada pill. The second study, including over 2,000 men and individuals with diverse gender identities, recorded only two cases of infection. This equates to a prevention rate of 99.9 percent, again surpassing Truvada.

The side effects include reactions at the injection site, headaches, and nausea.

The Cost Factor

Despite the impressive results, the drug’s high price may deter some. In the US, the annual cost will reach $28,218. According to reports, advocates are urging Gilead Sciences to lower the price significantly. We are working to make YEZTUGO available to anyone who needs or wants it, and we expect wide insurance coverage, a company spokeswoman stated.

Pre-exposure prophylaxis (PrEP) drugs have been available for over ten years. These drugs, usually requiring daily tablet use, have not drastically impacted the global infection rate. However, there is concern that the cost of the drug will prevent it from being used broadly. The World Health Organization estimates that, in 2022, 1.3 million people were newly infected with HIV worldwide (Source).

Ending the Pandemic

Worldwide, about 39.9 million people are infected with HIV, according to the WHO. The WHO and affiliated organizations aim to end the virus pandemic by 2030, which includes improving access to preventative drugs such as PrEP.