Mexico City. The Federal Commission for the Protection against Health Risks (Cofepris) authorized an innovative clinical trial to evaluate the interaction between gender affirmation therapy and treatments against the human immunodeficiency virus (HIV).
The research protocol will examine how estradiol (female sex hormone) relates to three therapeutic combinations for HIV: bictegravir/tenofovir/emtricitabine; dolutegravir/tenofovir/emtricitabine (or lamivudine) and any regimen that includes darunavir and cobicistat, with the aim of generating evidence to define the most effective and safe approach to HIV treatment in trans women.
Gender affirmation therapy is important because it contributes to improving the quality of life and facilitates adherence to HIV treatments in trans women, Cofepris said.
Evaluating this interaction will help strengthen therapeutic options and enhance the well-being of this group of patients living with the virus.
The clinical trial is part of 11 authorized by Cofepris in the first half of July. Among the new registered supplies are 20 drugs and 157 devices, of which 47 are specifically designed for medical care, such as endograft and implant systems for tibial fractures, intravascular infusion ports and aortic valves.
In addition, it has approved 68 diagnostic devices, including a cartridge for quantifying hepatitis C RNA.
Forty-two items of medical equipment were also recorded, including vital signs monitors, imaging catheters, duodenoscopes, ophthalmic lasers, and arm blood pressure monitors, among others.
Cofepris authorized these supplies after demonstrating, through exhaustive evaluation processes, that they meet the highest standards of safety, quality and efficacy.
The preparation and publication of the biweekly Therapeutic Expansion Report is an exercise in transparency by Cofepris towards regulated industries and patients, which demonstrates its commitment to health and equity in access to safe and effective medical treatments for the entire population.
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– 2024-08-14 07:30:12
