Gilead Sciences continues to dominate the HIV market as an updated version of Tenofovir – an active ingredient in Truvada – prepares to go head to head with it’s predecessor. Will Descovy be the next pre-exposure prophylaxis (aka PrEP) pill to ask your doctor about?
via POZ Magazine:
Following promising results from animal research, Gilead has begun planning a Phase III, randomized, double-blind trial comparing Descovy and Truvada’s efficacy in preventing HIV among an expected 5,000 transgender women and cisgender men who have sex with men who are at risk of contracting HIV.
The trial, called DISCOVER, will be conducted at numerous sites throughout the United States as well as in Canada and various Western European nations. Several U.S. sites have already started screening potential participants.
To be eligible, individuals must: be 18 years old or older; be HIV negative; report condomless anal sex with at least two partners in the past 12 weeks who are either HIV-positive or of an unknown HIV status; have been diagnosed with syphilis in the past 24 weeks or have been diagnosed with rectal gonorrhea or chlamydia in the past 24 weeks; have no known active or serious infections; have adequate kidney and liver function; have no evidence of viral hepatitis or acute hepatitis B virus (HBV) infection; have no evidence of or known history of hepatitis C virus (HCV) infection; have no evidence of osteoporosis or fractures related to bone fragility; and have no grade 3 or 4 protein or sugar in their urine that is unexplained or not manageable with treatment.
Gilead is also planning to conduct a trial of Descovy as PrEP among people with reduced kidney function.
The participants will be randomized to receive either Descovy or Truvada with instructions to take it daily. Neither the participants nor the trial investigators will know which medication the participants have received.
The participants will be followed for at least 96 weeks. Once all of them have been in the trial for at least that long, the investigators will unblind the study, revealing who was taking which tablet. At that time, the participants will be offered the opportunity to participate in an open-label extension phase of the trial, in which they will be offered unblinded Descovy.
Once everyone has been in the trial for at least 48 weeks and at least half of them have completed 96 weeks of follow-up, the researchers will determine how well each drug protected against HIV. Gilead estimates that this point will occur in February 2019 and that the study will reach its completion in September 2020.
CONTINUE READING: Gilead Begins Major Clinical Trial of Descovy vs. Truvada as PrEP
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