Inadequate adherence may have affected FEM-PrEP trial outcome
SEATTLE — The ability to assess the efficacy of tenofovir disoproxil fumerate plus emtricitabine in 2,056 African women may have been challenged by non-adherence among participants included in the FEM-PrEP trial, according to Lut Van Damme, MD.
As previously reported in Infectious Disease News, in April 2011, the FEM-PrEP trial was halted early as data did not demonstrate a protective effect of tenofovir disoproxil fumerate plus emtricitabine (TDF/FTC) combo.
The number of newly acquired HIV infections were similar between those assigned TDF/FTC (n=33) vs. placebo (n=35). The estimated HR for infection was 0.94 (95% CI, 0.59-1.52).
Additional data from a pre-specified sensitivity analysis that assessed women on the final day they may have taken TDF/FTC were also nonsignificant (HR=0.82; P=0.44). Adverse events, including vomiting and nausea were significantly higher among women in the TDF/FTC group.
Resistance to FTC was observed in five participants; TDF/FTC was detected in plasma of less than 50% of participants with and without HIV.
“We do have the ability to follow these participants and we will be able to see how the drug works over time,” Van Damme said during a press conference here.
For more information:
- Van Damme L. #32LB. Presented at:19th Conference on Retroviruses and Opportunistic Infections; March 3-8, 2012; Seattle.
Disclosures: The researchers report no relevant financial disclosures.
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