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FDA approves drug for preventing HIV, but not in women

Early in the 1980s, the epidemic of HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immunodeficiency Syndrome) started with reports of young, previously healthy U.S. adults having severe illnesses and death from AIDS. The cause of AIDS had yet to be discovered. Within the next four years, the previously unknown virus, HIV, was discovered and announced as the cause of AIDS. Since the discovery of HIV, there have been strides in research toward treating those infected. Antiretroviral drugs have been created, which allow those with HIV to live long and healthy lives. Though there still is no cure for the disease, the antiretroviral drugs showed an immediate reduction in hospitalization and death rates by 60-80% once they were brought into the HIV treatment plan.
 
Without a curative treatment for HIV infection, it is important to prevent it from spreading in order to eventually eradicate, or get rid of, the disease entirely. However, there still are tens of thousands of people in the U.S. diagnosed with HIV every year. For that reason, President Trump announced an initiative in February 2019, “Ending the HIV Epidemic: A Plan for America”. This plan aims to eliminate new HIV infections, especially in those communities affected most. One of the goals is to decrease new infections by 90% in the next ten-years.
 
Preventing HIV infection in those who are not already infected by taking a daily medication is called pre-exposure prophylaxis (PrEP). In 2012, the FDA (Food and Drug Administration) approved Truvada® as the first PrEP for HIV-negative people to prevent sexual transmission of HIV. The drug trials leading to the approval of Truvada® showed a 42-62% decrease in the risk of getting HIV while using PrEP. Until now, Truvada® was the only available product approved for PrEP. Early in October 2019, the FDA approved a second drug for PrEP, called Descovy®. This second medication for PrEP was studied in a large trial of men and transgender women who have sex with men. Everyone in the trial was at risk of HIV infection.

The study showed Descovy ® was similar to Truvada® in reducing the risk of getting HIV. Unlike Truvada®, Descovy® was not studied in those who have receptive vaginal sex. Therefore, Descovy® is not indicated for those at risk of HIV infection from receptive vaginal sex. The most common side effect in people taking Descovy® was diarrhea. See our blog about What To Do If Medications Are Causing Diarrhea

There are certain warnings to taking the medicine, as with all drugs, particularly for those who also have hepatitis B virus and stop the medication. Both Truvada® and Descovy® are easy to use and require taking only one tablet by mouth once a day with or without food. Your doctor should confirm that you are HIV negative prior to starting PrEP and every three months after starting the medication. He or she also may check a few other lab values before starting the medication.
 
The approval of a second medication for PrEP is very important for increasing access to preventative medications and reaching the goals for decreasing the number new HIV diagnoses. If cost is a concern, there are cost saving coupon cards through the drug manufacturers that can reduce co-pays to as low as $0. In addition to PrEP, those who are at risk of HIV-infection should also adopt safe sex practices, including condoms, to help reduce the risk of sexually acquired infections. If you, or someone you know, is at risk for HIV infection and might benefit from PrEP, talk to your doctor and encourage others to start the discussion.
 
Resources:


1) https://www.fda.gov/news-events/press-announcements/fda-approves-second-drug-prevent-hiv-infection-part-ongoing-efforts-end-hiv-epidemic
2) https://www.hiv.gov/hiv-basics/overview/history/hiv-and-aids-timeline
3) https://www.avert.org/professionals/history-hiv-aids/overview
4) https://www.cdc.gov/hiv/statistics/overview/ataglance.html
5) https://www.fda.gov/files/science%20&%20research/published/HIV-PrEP-drug-can-be-part-of-strategy-to-prevent-infection-in-at-risk-adolescents.pdf
6) Truvada cost assistance: https://www.truvada.com/how-to-get-truvada-for-prep/truvada-cost
7) Descovy cost assistance: https://www.descovy.com/co-pay-assistance

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