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PrEP in Europe: New research under way
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GLASGOW — Despite major advances in HIV therapy, the number of new HIV infections in Europe remains high, and new prevention strategies must be assessed to curb the incidence of HIV infection, Jean-Michel Molina, MD, of Saint-Louis Hospital and University of Paris, said here at the HIV11 Congress .
In the wake of the recent FDA approval of the first combination pill (emtricitabine plus tenofovir disproxil fumarate; Truvada, Gilead) for pre-exposure prophylaxis (PrEP) in the United States, Molina discussed issues that must be addressed before approval and rollout of PrEP in Europe.
Lack of awareness
Only 30% of men who have sex with men in France reported ever hearing about PrEP, and just 12% reported feeling well informed, according to results of a July online survey. Of 1,000 MSM surveyed, 18% were ready to use PrEP if it was proved to be 50% effective. Most would prefer on-demand over daily PrEP (62.8% vs. 24.6%). Of concern, Molina said, is the 40% of respondents who said they might reduce condom use if PrEP were available and the 27% who said they may completely stop condom use.
“These results show that more information about PrEP is needed, particularly in the [MSM] community in Europe,” Molina said.
Available data
Although significant data from CAPRISA 004, FEM-PrEP, iPrEx, Partners PrEP, TDF2 and VOICE trials are now available, results have generally yielded encouraging but inconsistent results, Molina said. Efficacy of PrEP in these trials has ranged from ineffective in the VOICE trial to a 39% reduction in HIV incidence in CAPRISA 004, to a 67% to 75% reduction in Partners PrEP.
“These results have generated a lot of controversy about the implementation of PrEP. Some think the data are good enough to rollout PrEP in key populations at higher risk [in Europe]; others think more research is needed before PrEP is implemented because of concerns around safety, emerging resistance, cost and change in sexual behavior that might offset the benefit of PrEP,” Molina said.
Current, upcoming trials
Researchers are conducting new research to address these issues and to assess PrEP regimens in open-label extension studies (iPrEx-OLE in MSM), intermittent PrEP regimens to improve adherence, new ART classes and new modalities of drug delivery, according to Molina.
“There are still a number of unanswered questions,” he said. “We need to evaluate and develop a PrEP regimen with better efficacy.”
The multicenter, open-label, randomized PROUD trial will include high-risk HIV-negative MSM in the United Kingdom. Participants will be randomly assigned to immediate or delayed oral emtricitabine-tenofovir, plus a risk-reduction package. Primary endpoint is time to accrual of more than 500 patients; other endpoints will include safety, adherence and risk compensation. This is a feasibility study to assess whether a larger trial looking at clinical effectiveness can be developed, Molina said.
The phase 3 French National Agency for Research on AIDS and Viral Hepatitis (ANRS) IPERGAY trial will examine the efficacy of on-demand PrEP in MSM in Europe who have condomless anal sex with at least two partners. The randomized, double blind, placebo-controlled trial was launched in France in early 2012 and will expand to Canada and other European countries, said Molina, who is a researcher for the trial. Participants will be assigned full prevention services or placebo before and after sex. Target enrollment is 2,000 participants.
Regarding the future of PrEP in Europe, Molina said: “Oral PrEP should be seen as an additional, not an alternative, prevention tool. PrEP will remain controversial, but will contribute to putting HIV prevention at the top of the agenda.”
For more information:
Molina JM. Pre-exposure prophylaxis: Where are we in Europe? Presented at: HIV11 Congress; Nov. 11-15, 2012; Glasgow.