Later this month, leading scientists and cutting-edge thinkers will gather at the International AIDS Society’s 9th IAS Conference on HIV Science in Paris to discuss the latest scientific discoveries in HIV prevention, care and treatment. These discoveries hold the potential to accelerate progress toward the global 90-90-90 targets set forth by the Joint United Nations Programme on HIV/AIDS (UNAIDS). And, they are especially important for key populations — including men who have sex with men, sex workers, transgender people and people who inject drugs — who shoulder a disproportionate burden of HIV. UNAIDS estimates that 45 percent of all new HIV infections among adults worldwide occur among these key populations and their sex partners. Reaching these groups with new technologies and approaches is essential to ending the epidemic.
Final results from two research studies presented at IAS 2015 yesterday demonstrated clear scientific evidence on the benefits of early initiation of antiretroviral therapy (ART). Building on early results of HPTN 052 released in May 2011 that then showed a 96 percent reduction in HIV transmission, the study results presented yesterday provide conclusive evidence that ART should be provided to all HIV-positive people as soon as they are diagnosed for the benefit of both themselves and their sexual partners.
Jens Lundgren of the University of Copenhagen presented the initial results of the Strategic Timing of AntiRetroviral Treatment (START) study, a randomized trial looking at whether starting ART in people with CD4+ cell counts above 500 cells/mm3, rather than waiting for CD4+ cell counts to drop below 350 cells/mm3, reduces the occurrence of serious morbidity and mortality. START was recently unblinded by the international Data & Safety Monitoring Board (DSMB) 18 months early due to data that showed very clear benefits of immediate treatment versus delayed treatment. Previous studies and guidance from the World Health Organization (WHO) suggested that ART should not be given to patients unless they had symptomatic HIV and/or CD4+ counts that were below 350 cells/mm3. The interim results from START show that ART is safe and effective for all HIV-infected persons regardless of CD4+ count.
Now that the U.S. Food and Drug Administration has approved the use of the antiretroviral drug combination of tenofovir disoproxil fumarate and emtricitabine (Truvada®) for HIV prevention, its success will depend on user adherence to the daily drug regimen.
Several trials of Truvada as pre-exposure prophylaxis (PrEP) showed it is most effective when adherence is high. Two trials, VOICE and FEM-PrEP, were unable to determine whether Truvada worked, likely because most participants did not take the study pills daily as directed.
One explanation for low adherence to PrEP is that study participants might have thought they were not at risk of HIV infection.
A study from FHI 360’s Preventive Technologies Agreement (PTA) explored this possibility. Our analysis of data from a randomly assigned cohort of 150 participants who received Truvada in the FEM-PrEP trial yielded some intriguing results, presented in a late-breaker poster this week at the International AIDS Society conference (IAS 2013) in Kuala Lumpur, Malaysia.