by Jeffrey T. Kirchner, DO, AAHIVS, AAHIVM Chief Medical Officer
March 31, 2020
Gantner, P. et al. Elvitegravir-Cobicistat-Emtricitabine-Tenofovir Alafenamide Single-tablet Regimen for Human Immunodeficiency Virus Postexposure Prophylaxis. Clin Infect Dis 2020;70(5):943-46. DOI:10.1093/cid/ciz577
The most recent U.S. guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or non-occupational exposure to HIV include several multi-drug regimens. Although these are likely effective they have 28-day completion rates of only 56% to 78%. Several studies done outside the U.S. have evaluated single-tablet regimens (STR) for PEP and found higher completion rates. This open-label, single-arm trial from France included persons > 18 years with potential HIV exposure in the previous 48 hours who were subsequently treated with elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide (E/C/F/TAF). The primary end point was PEP completion at day 28. Additional end points included adherence, quality of life, safety and efficacy. Elvitegravir concentrations at day 14 were measured as a marker of adherence. The study initially enrolled 98 individuals of whom 78% were male with a median age of 31 years. Eight reported possible occupational and 87 possible sexual exposure to HIV. Seventy-eight (82%) ultimately completed the full 28-day PEP course. Most failures were due to lack of follow-up. There were no significant changes from baseline in quality of life scores however 68% reported at least one adverse event. These most common were weakness, GI upset, and headache however there were no discontinuations of PEP due to these symptoms. There were also no renal or hepatic lab abnormalities noted. At the end of the study, day 120, there were no HIV seroconversions. Although there was high-rate of subjects lost to follow-up, the authors believe these data support the uses of E/C/F/TAF for PEP.
This is one of several studies that support the use of STRs for HIV PEP. The most recent U.S. guidelines were last published in April 2016 and specifically recommend tenofovir DF/emtricitabine taken with raltegravir 400 mg bid or dolutegravir 50 qd for PEP. Based on available data it would be very reasonable to consider a STR for PEP if based on HIV-risk exposure, medical therapy was clinically indicated. Hopefully updates of the U.S. guidelines will be forthcoming.
The author has no conflicts of interest to disclose.
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