FDA Approves 2nd Only HIV Prevention Drug, But It’s NOT for Women

Health Wellness

HIV, more properly known as Human Immunodeficiency Virus, is the virus that causes AIDS – Acquired Immune Deficiency Syndrome. Basically, it means that one’s immune system is so weakened that they are susceptible to many normally non-fatal diseases which could be fatal for a person with AIDS.

According to the CDC:

In 2017, 38,739 people received an HIV diagnosis in the United States and dependent areas. The annual number of new diagnoses declined 9% from 2010 to 2016 in the 50 states and the District of Columbia.

a American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, the Republic of Palau, and the US Virgin Islands…

An estimated 1.1 million people in the United States had HIV at the end of 2016, the most recent year for which this information is available. Of those people, about 14%, or 1 in 7, did not know they had HIV…

In 2017, gay and bisexual men accounted for 66% of all HIV diagnoses in the United States and 6 dependent areas. In the same year, individuals who got HIV infection through heterosexual sex made up 24% of all HIV diagnoses.

On July 16, 2012, the FDA approved the drug Emtricitabine/tenofovir, better known as Truvada. It was approved for both treatment and prevention of HIV and AIDS. Like so many other drugs on the market today, Truvada came with its side effects, which include diarrhea, dizziness, headaches, back pain, trouble sleeping and changing the color of the skin on the soles of the feet and palms of the hands. In some cases, Truvada has caused a patient’s immune system to go from being inactive to being overactive, causing a host of severe side effects.

However, being faced with the consequences of HIV/AIDS, the risk to many is worth it.

Now there may be a second choice, but not for women. What is it and why is it not approved for women?

The Food and Drug Administration on Thursday approved a new drug, Descovy, for prevention of infection with H.I.V., only the second drug approved for this purpose.

The first, Truvada, has become a mainstay of government efforts to turn back the H.I.V. epidemic. But the F.D.A. approved Descovy for use only in men and transgender women, because its maker, Gilead Sciences, tested it only in those groups.

The approval explicitly excludes women, and does not outline a plan for making the drug available to them. Some activists and scientists said the approval sets a dangerous precedent by allowing companies to dodge the expensive trials needed to test medicines in women.

Women, before you begin to protest, be assured that the FDA is planning to require Gilead to test Descovy in women. The question is whether or not the drug will react differently in vaginal tissue than it does in rectal tissue, something Gilead had yet to test.

Oh yeah. In case you’re interested, Gilead is also the manufacturer of Truvada, giving them a corner on the market, at least for now.

 

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