Comparison of two HIV postexposure prophylaxis regimens among men who have sex with men in Amsterdam: adverse effects do not influence compliance.
ABSTRACT To compare 2 regimens for HIV postexposure prophylaxis (PEP) as to safety, adherence, outcome, and follow-up in men who have sex with men (MSM) in Amsterdam.
Since 2000, all MSM starting HIV PEP in Amsterdam have been followed in 1 location. The regimen was comprised of zidovudine or lamivudine and nelfinavir (regimen 1) until 2005, when nelfinavir was replaced by atazanavir (regimen 2). All patient data, including data on PEP side effects and testing for alanine aminotransferase (ALT), were systematically recorded and compared between the 2 regimens from 2000 to 2007.
HIV PEP was prescribed 309 times to MSM. Of the 261 who were followed up, 237 (91%) completed their 28-day course. Although fewer patients had diarrhea on regimen 2 than on regimen 1 (P = 0.00), the proportion completing either course was the same: 98 of 110 (89%) and 139 of 151 (92%), respectively (P = 0.42). Only 1 patient with severely elevated ALT was advised to stop PEP, he also had serious illness. MSM at least 30 years of age and MSM who had sex with a partner known to be HIV-positive completed their course significantly more often than those under 30 and those who had sex with a partner of unknown HIV status (P < 0.005). Of MSM who completed PEP, 5 seroconverted for HIV despite good adherence to PEP. None of their viruses were resistant to the PEP regimen used.
No difference in adherence was found between the 2 regimens, even though fewer adverse effects were reported on regimen 2. ALT need not be routinely tested to monitor adverse effects. The 5 seroconversions were not likely caused by PEP failure, but rather by ongoing HIV exposures.
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ABSTRACT: The National HIV/AIDS Strategy proposes to scale-up post-exposure prophylaxis (PEP). Intensive risk reduction and adherence counseling appear to be effective but are resource intensive. Identifying simpler interventions that maximize the HIV prevention potential of PEP is critical. A randomized noninferiority study comparing 2 (standard) or 5 (enhanced) risk reduction counseling sessions was performed. Adherence counseling was provided in the enhanced arm. We measured changes in unprotected sexual intercourse acts at 12 months, compared with baseline; HIV acquisition; and PEP adherence. Outcomes were stratified by degree of baseline risk. We enrolled 457 individuals reporting unprotected intercourse within 72 h with an HIV-infected or at-risk partner. Participants were 96% male and 71% white. There were 1.8 and 2.3 fewer unprotected sex acts in the standard and enhanced groups. The maximum potential risk difference, reflected by the upper bound of the 95% confidence interval, was 3.9 acts. The difference in the riskier subset may have been as many as 19.6 acts. The incidence of HIV seroconversion was 2.9% and 2.6% among persons randomized to standard and enhanced counseling, respectively, with a maximum potential difference of 3.4%. The absolute and maximal HIV seroconversion incidence was 9.9% and 20.4% greater in the riskier group randomized to standard, compared with enhanced, counseling. Adherence outcomes were similar, with noninferiority in the lower risk group and concerning differences among the higher-risk group. Risk assessment is critical at PEP initiation. Standard counseling is only noninferior for individuals with lower baseline risk; thus, enhanced counseling should be targeted to individuals at higher risk.Clinical Infectious Diseases 07/2011; 53(1):76-83. DOI:10.1093/cid/cir333 · 9.42 Impact Factor