The Miriam Hospital Institutional Review Board approved the study in October 2007. Recruitment and enrollment began in November 2007 and participant follow-up lasted for 9 months. In 28 recruitment weeks, 194 persons were screened and 58 enrolled. Participants were primarily college-educated MSM with history of STI other than HIV, with 88% of the male sample reporting only other male partners and 9% being bisexual (). The two women who met entry criteria did so because of unprotected anal intercourse, and the male participant who had sex only with women met criteria because he reported intranasal drug use and unprotected anal intercourse. For MSM mean age was 42 (range, 21–58 years) with 65% older than 40, while overall mean age was 42 (range, 21–65 years) with 66% older than 40.
Baseline Characteristics (at Enrollment) of 58 HIV-Infected Acute Hepatitis C Virus Study Participants
Among MSM, at baseline, most reported that in the prior 3 months they had engaged in high-risk sexual transmission behaviors, including unprotected anal intercourse, participation in group sex, meeting a sex partner via the Internet, and/or having sex with multiple partners. Stimulant and club drug use via the oral or intranasal route in the prior 3 months were common, while heroin and IDU were rare. Unprotected sex often occurred under the influence of drugs or alcohol. Despite these risks, over half (54%) of the MSM rated their HCV risk as not high.
Self-reported HCV risk and participation in several risk behaviors declined during the study (), including the odds of participating in unprotected receptive or insertive anal intercourse and engaging in unprotected sex while high on drugs or alcohol. The number of sexual partners decreased with each successive study visit. No differences were found for changes in other risk factors. Changes in two outcomes—unprotected fisting and seeing blood during sex—were not evaluated further due to their low baseline prevalence (less than 20%). Although participation in several risk behaviors declined during the study, these behaviors continued to occur at the third follow-up visit. For example, 31% of participants were still engaging in unprotected receptive anal intercourse, 17% in unprotected insertive intercourse, and 17% in group sex. Baseline reported recent use of erectile dysfunction medications was found to be significantly associated with recent participation in group sex (odds ratio [OR]=4.98, 95% CI 1.20 to 20.60) and marginally associated with the number of sexual partners (OR=1.45 for each successive higher ordinal partner group, 95% CI 0.99 to 2.12, p=0.06) and age group (OR=2.41 for each higher age group, 95% CI 0.85, 6.80, p=0.10). Engaging in insertive anal intercourse was not found to be significantly associated with the use of erectile dysfunction medications (OR=2.10, 95% CI 0.52, 8.53, p=0.29).
Estimated Change in Risk Behavior and Perceived Risk of HCV for Each Successive Study Visit in the Men Who Have Sex with Men Cohort
At baseline, eight participants had a recent syphilis diagnosis. These patients were either being treated or had recently completed treatment for syphilis. Four of these eight participants were reinfected with syphilis during the study period. One additional participant without a recent syphilis history was newly infected with syphilis during the study follow-up period. One participant acquired chlamydia during the study period.
There was one newly diagnosed case of acute HCV over a screening period of 50 person–years. The annual incidence of acute HCV in the study cohort was estimated to be 2.0% per year (95% CI 0.05% to 11.1%). The case was a 56-year-old MSM who was not sexually active. He was injecting heroin and cocaine while being prescribed buprenorphine, with a recent change in injection practices with a period of syringe sharing. He was a binge alcohol user. HCV antibody was negative upon entry into HIV care 7 years prior, with several subsequent negative antibody tests including at study entry. For 7 years, his ALT had been within normal limits. At baseline, in November 2007, his ALT was 144
IU/mL and his HCV RNA 529,000
IU/mL. The peak ALT was 336
IU/mL with HCV seroconversion 4 weeks later. ALT declined to 21
IU/mL 8 weeks after RNA detection. At acute HCV diagnosis, his CD4+
cell count was 579 cells/μL, with undetectable HIV RNA on tenofovir, emtricitabine, darunavir, ritonavir, and raltegravir. His elevated ALT and total bilirubin (8.0
mg/dL) were attributed to HAART-induced hepatotoxicity despite hospitalization with an injection-related abscess and jaundice, until it was appreciated that he was an acute HCV study participant and that his study HCV RNA was detectable. The participant declined therapy for acute HCV genotype 2 infection despite recommendation to accept treatment, and developed chronic HCV. However, the participant discontinued alcohol use, and began attending a coinfection support group and HCV clinic visits.
For the whole study sample, ALTs were collected at 164 study visits, 71% of total projected ALTs. Of 58 participants, 88% had at least 1 ALT during the 9-month follow-up period. Seventeen had blood drawn and ALT data collected for all 4 study visits (29%), 21 participants completed 3 study visits (36%), 13 completed 2 study visits (23%), and 7 attended the baseline visit only (12%). In all 170 of 232 (73%) BRQs were completed and 64% of possible follow-up BRQs were completed.
During 106 follow-up visits, there were 7 instances (6.6%) in which a rise in ALT prompted HCV RNA testing. Pooling was utilized for 5 of these 7 while 2 participants had individual samples tested. A total of 47 individual samples were pooled and a total of 21 pooled tests were performed. Different study visits (baseline and months 3, 6 and 9) were represented in each pool. Per protocol, all participants had HCV RNA testing at entry; 34 participants utilized pooling at baseline.