by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

August 15, 2023

Featured Literature:

Inciarte A, Ugarte A, Martínez-Rebollar M, et. al for the DORAVIPEP Study Group.  Doravirine/lamivudine/tenofovir disoproxil fumarate for nonoccupational HIV-1 postexposure prophylaxis: a prospective open-label trial (DORAVIPEP).  Open Forum Infect Dis.  2023 Jul 19; 10(8):ofad374.  doi: 10.1093/ofid/ofad374.  PMID: 37539061    

DORAVIPEP evaluated the use of co-formulated DOR/3TC/TDF as nonoccupational post-exposure prophylaxis (PEP).  This was a single-center, open-label, single-arm trial which included 399 non-pregnant adults (91% male and 84% MSM) seeking emergency department care after consensual, potential exposure to HIV between September 2019 and March 2022.  Participants received a complete 28-day prescription, with the first dose initiated immediately on day 0.  34.6% reported prior PEP use and 6% had initiated pre-exposure prophylaxis (PrEP) prior to the study.  During the follow-up period, 29% discontinued PEP early; median time reported for PEP duration was 8 days.  The most common reason for non-completion was loss to follow-up, followed by intolerance and adverse events.  In multivariable analysis, PEP non-completion was associated with younger age; among individuals who attended at least 1 post-enrollment visit, both younger age and any AE emergence was associated with PEP non-completion.  The most common AE types were gastrointestinal (35%), neurological (21%), and musculoskeletal (9%).  No clinically significant laboratory value changes were observed, and laboratory abnormalities were not the reason for PEP non-completion in any participant.  Self-reported adherence in assessed participants was 336/350 (96%) and 281/285 (99%) at day 7 and week 4, respectively.  No cases of seroconversion were identified.

Author’s Commentary:

Results of this single-arm trial suggest that co-formulated DOR/3TC/TDF is a very reasonable option for use as non-occupational post-exposure prophylaxis.  Although the study didn’t include a direct comparison with standard, INSTI-inclusive regimens, no significant safety concerns emerged.  Overall, the tolerability of (and adherence to) DOR/3TC/TDF observed among this study’s population are fairly similar to results from other contemporary PEP studies.  Additionally, this trial’s results highlight opportunities to revisit and refine laboratory (e.g., chemistry panel and hematologic) monitoring recommendations/practices as well as substance use/harm reduction and PrEP counseling integration into PEP programming.     

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