Assessing Benefits of Pre-Exposure Prophylaxis Relative to Risks of Drug Resistance

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"Resistant infections during PrEP should be weighed against the numbers of infections averted," stated renowned HIV prevention and PrEP (pre-exposure prophylaxis) researcher Robert Grant, M.D., M.P.H., of the Gladstone Institute for Virology and Immunology in a PrEP-focused session at AIDS 2016 in Durban, South Africa. "Each of which will require lifelong therapy and the attendant annual risk of virologic treatment failure with drug resistance," he noted.
The analysis comprised results from six clinical trials and one demonstration project. All trials included in the review used rapid antibody tests prior to PrEP initiation and retrospectively tested baseline specimens for HIV RNA among those who became HIV positive. Resistance in all the trials was measured using clinical genotypic tests, which can detect drug resistance present in 20% or more of the virus population, according to Grant; further, four of the trials used sensitive genotypic assays that are able to detect resistant viral variants present in low abundance (greater than about 1% of the virus population).

The absolute risk of excess drug resistance associated with incident or emergent infection in all six trials was 0.05% -- low risk, in other words. Grant added that PrEP would need to be provided to roughly 1,844 people (known as the "number needed to harm," or NNH) to get one drug-resistant infection. Conversely, the number of people who would need to get PrEP in order to prevent one HIV infection is -- depending on the study and adherence results therein -- between 13 and 60 individuals.
"The benefit of PrEP in this overall analysis far exceeds the risk of drug resistance," Grant stated, "and the risk of drug resistance is rare."