Research scientists have suspended a drug trial looking at the efficacy of using powerful antiretroviral medications to prevent HIV infections.
The study, called FEM- PrEP, was being conducted by FHI, a global research firm. It was designed to determine if the use of pre-exposure prophylaxis (PrEP) can prevent HIV infection in women. PrEP was recently determined to be effective in preventing infections in men who have sex with men. That study, called iPrEx, was released late last year and found that in the study participants who took the study medication, Truvada, daily as prescribed had a 90 percent reduction in HIV infections. The overall study proved a 44 percent efficacy.
That was not the case in the FEM PrEP study. A statement on the FHI website said the study should be concluded because it “will be highly unlikely to be able to demonstrate the effectiveness of Truvada [emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)] in preventing HIV infection in the study population.”
The site went on to note the possible reasons for the failure of the study:
“There are a number of possible reasons for the study findings, including low adherence to study regimen, a true lack of effect of the product among women (versus men who have sex with men), or other factors still to be determined. FHI will be conducting further analyses and will share additional findings in the coming months. The IDMC commended the trial team on a study conducted to a high standard with good follow-up and careful attention to good clinical practice and ethical standards.”
Scientists continue to work on other forms of prevention including microbicides. A study released last summer found an ointment of antiretroviral medications applied to the vagina prior to sex was successful in preventing HIV infection.