Doravirine plus lamivudine and tenofovir disoproxil fumarate (DOR/3TC/TDF) is a well-tolerated option for nonoccupational HIV postexposure prophylaxis (PEP), according to results of a study published in Open Forum Infectious Diseases.
Researchers conducted a prospective, open-label, single-arm phase 4 trial between September 2019 and March 2022 to evaluate a single-tablet regimen comprising DOR/3TC/TDF for nonoccupational HIV PEP. Eligible patients were adults in Spain who were admitted to an emergency department following potential HIV exposure. Patients initiated PEP at enrollment and continued treatment for 28 days. The primary endpoint was the number of patients reporting nonadherence to the 28-day PEP regimen. Factors associated with PEP discontinuation were determined via multivariable logistic regression.
A total of 399 patients were included in the analysis, of whom the median age was 30 (IQR, 27-36) years, 91% were men, 60% were European, and 82% were men who have sex with men (MSM). In addition, 138 patients reported prior PEP use, and 126 reported prior sexually transmitted infections.
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At day 28, 29% of the study population prematurely discontinued PEP. The median duration of PEP use until discontinuation was 8 (IQR, 0-14) days. The most common reason for discontinuation was loss of follow-up (91%), followed by treatment intolerance or adverse events (AEs; 7%), and withdrawal of consent (2%).
The researchers also performed a modified intention-to-treat analysis (n=356), comprising patients who attended at least 1 follow-up visit. Among this population, the rate of premature PEP discontinuation at day 28 was 20%, and the follow-up rate was 89% on day 7, 72% at week 4, and 63% at week 12.
In the multivariable logistic regression analysis, younger age was independently associated with premature PEP discontinuation (odds ratio [OR], 0.94; 95% CI, 0.91-0.97; P <.001). The emergence of any AE during treatment was also independently associated with premature discontinuation (OR, 1.96; 95% CI, 1.13-3.38; P =.016), but only when the analysis was restricted to patients who attended at least 1 follow-up visit.
There were 183 AEs reported among 123 (31%) patients (incidence rate, 60.09 per 100 person-months; 95% CI, 51.98-69.45), most of which were of mild severity (82%).
Overall, 88% of patients were evaluated for treatment adherence on day 7, and 71% were re-evaluated on day 28. Of 350 patients who self-reported PEP adherence, adherence rates were 96% and 99% at day 7 and week 4, respectively.
Study limitations include the lack of comparator arm, the open-label design, and the predominance of MSM. The researchers also noted that the COVID-19 pandemic may have contributed to the low follow-up rate.
According to the researchers, “Our study sheds light on PEP use in MSM populations, predominantly observed in larger cities within affluent nations.”
Disclosure: This research was supported by Merck Sharp & Dohme. Please see the original reference for a full list of disclosures.
Reference
Inciarte A, Ugarte A, Martínez-Rebollar M, et al; and 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. Published online July 19, 2023. doi:10.1093/ofid/ofad374
This article originally appeared on Infectious Disease Advisor
