Gilead Sciences Inc. just won approval for a second drug used for HIV prevention. On Oct. 3, the U.S. Food and Drug Administration (FDA) announced the approval of Descovy for pre-exposure prophylaxis (PrEP).
Descovy contains tenofovir alafenamide, or TAF, an active ingredient that helps treat HIV without the damaging side effects to kidneys and bones that some people experience with Gilead’s other HIV drugs containing tenofovir disoproxil (TDF).
“PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” Dr. Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.”
The new Descovy indication only applies to men and transgender women because the drug was not tested in women.
The exclusion of women in clinical trials “should be unacceptable in these days and times,” Dr. Rochelle Walensky, chief of infectious diseases at Massachusetts General Hospital, told the New York Times.
The Times reported the FDA will require Gilead test Descovy for PrEP in women and is apparently considering a clinical trial in Africa.
Descovy was originally approved in 2016 in combination with other antiretroviral drugs to treat HIV in adults and adolescents 12 years of age and older.
The new indication for PrEP represents an important milestone in the government’s effort to combat the HIV epidemic. In his February 2019 State of the Union Address, President Donald Trump presented an initiative to fight the epidemic and end new cases of HIV/AIDS in the United States.
The exclusion of women in the new indication, however, means a portion of at-risk people do not have the same access to potentially life-saving medications.
Another barrier to access is the high cost of these drugs. The price of the only other PrEP drug on the market comes in at around $20,000 a year. According to an emailed statement from the company, Gilead plans to sell Doscovy at around the same price as Truvada.
The patent for Truvada is set to run out and lower cost generic versions of the drug are expected to come out next year. However, the drug is linked to serious side effects in some patients, especially when taken long-term.
Truvada has been linked to dangerous kidney issues, including decreased kidney function and kidney failure. It is also linked to bone issues, including bone and tooth loss, a potential symptom of decreased kidney function.
Hundreds of lawsuits are currently pending in state and federal courts related to Gilead’s TDF-containing drugs, including Truvada, Viread, Atripla, Complera, and Stribild. The lawsuits accuse Gilead of negligently designing a drug it knew could cause serious side effects and that the company had a viable and safer alternative at its disposal when it sought approval for its TDF drugs.
At the same time Gilead was researching and developing TDF drugs, it was also researching TAF, which was just as effective and less damaging to the kidneys and bones. Gilead decided only to seek approval of TAF when it was close to losing its patent exclusivity on blockbuster TDF drugs—roughly a decade after the FDA approved the first TDF drug.
If you took a TDF drug, including Truvada, Viread, Atripla, Complera, or Stribild, and experienced kidney or bone problems, you may be entitled to financial compensation. Call 800-631-5656 for a free, no-obligation consultation or visit our website to fill out a free claims form and see if you qualify for a Truvada lawsuit today.