FDA Approves Descovy For Use As PrEP Drug

October 14, 2019
by John Kelly, MD
FDA Approves Descovy For Use As PrEP Drug

The U.S. Food and Drug Administration recently approved the drug Descovy for use in at-risk teenagers and adults for HIV-1 pre-exposure prophylaxis in the hopes of decreasing the chance of becoming infected with HIV-1 infection through sexual contact.

The drawback? The FDA has not approved the drug for people who have vaginal sex, as studies have not been conducted to determine the effectiveness.

According to the FDA’s Center for Drug Evaluation and Research Deputy Director of Division of Antiviral Products Dr. Jeffrey Murray, the approval offers more prevention choices for some patients who may be at risk for catching HIV. It also helps increase the U.S. Department of Health and Human Services and FDA to further the development of both HIV prevention and treatment in the hopes of reducing HIV infections.

In 2017, the CDC said nearly 39,000 people were told they had HIV, and to combat the issue, President Donald Trump announced the “Ending the HIV Epidemic: A Plan for America” initiative during the State of the Union address Feb. 5, 2019.

The chance to alleviate any chance for new U.S. HIV infections means giving the hardest-hit communities the latest resources, technologies and expertise that will address it. The goal is to decrease the rate of new infections by 75 percent within five years and 90 percent within the next 10 years. By doing so, it would mean 250,000 new HIV infections would not take place.

PrEP (pre-exposure prophylaxis) is the one HIV prevention method people without HIV can take every day to decrease their chances of catching the virus that causes AIDS if exposed to it. Descovy use for PrEP needs to be added to an already broad strategy, such as practicing safe sex and adhering to the daily use.

Descovy for PrEP was reviewed for safety and efficiency in a random multinational trial of nearly 5,400 HIV negative men and transgender women having sex with men and at a heightened risk of getting HIV-1. The trial looked at once-daily Descovy to Truvada, which also helps to reduce the rate of HIV-1 infection. The drug trial participants were followed up to 96 weeks.

At the end of the trial, Descovy’s rate of infection prevention was nearly identical to Truvada, but the most common side effect for Descovy was diarrhea.

People with hepatitis B and use Descovy should be mindful that not using tenofovir disproxil fumarate or emtricitabine to treat HBV problems could cause them to worsen. Descovy should only be given to those individuals who have tested negative for HIV the last three months.

The FDA approved Descovy’s use in 2016 for use with other antiretroviral drugs in the treatment of HIV-1 infection in both pediatric and adult patients.


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