Abstract
Background: There are limited studies on the medication regimen of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in China. This study compared the effectiveness of and adherence to two prophylactic HIV medication regimens, which provided evidence and guidance for the application and promotion of the PrEP strategy in the MSM population in China. Methods: We conducted an open, non-randomized, multicenter, parallel, controlled clinical intervention study in western China. Subjects were recruited by convenience sampling at research centers in Chongqing, Guangxi, Xinjiang and Sichuan, China from April 2013 to March 2015, and they were categorized into the daily PrEP, event-driven and blank control groups. Tenofovir disoproxil fumarate (TDF; 300 mg/dose) was administered to subjects in the daily PrEP and event-driven groups, and all subjects were followed up every 12 weeks for 96 weeks. Demographic, behavioral, psychological characteristics and AIDS-related attitudes were assessed using self-completed questionnaires. TDF serum concentrations in subjects in Chongqing and Sichuan were quantified after systematic sampling. Results: Of the 2422 enrolled MSM, 856 were eligible for statistical analysis (PrEP group: 385 and event-driven group: 471); 30 and 32 subjects in daily PrEP and event-driven groups, respectively, were HIV-positive; the incidence of HIV infection was as follows: daily PrEP group, 6.60 cases/100 person-years and event-driven group, 5.57 cases/100 person-years (relative risk (RR) 95% confidence interval (CI) was 0.844 (0.492–1.449)); HIV incidence did not differ significantly when stratified by medication adherence or sites. When the medication adherence rate was ≥80%, the median TDF serum concentrations were 0.458 mg/L, and 0.429 mg/L in the daily PrEP, and event-driven groups, respectively (not significant; p > 0.05); Subjects who were in the event-driven PrEP group (OR = 2.152, 95% CI: 1.566–2.957), had fewer male sexual partners in the last two weeks (OR = 0.685, 95% CI: 0.563–0.834), were one year older on average (OR = 1.022, 95% CI: 1.002–1.043), considered that medication kept them safe, were less worried about others knowing they took medicine and were more likely to have high adherence. Conclusions: The efficacies of daily TDF and event-driven TDF use were not significantly different in preventing new infections among HIV-negative MSM. Event-driven TDF use is economical and effective and is worth popularizing. Our results provide evidence for the application and promotion of the PrEP strategy in the MSM population in China.
Highlights
Acquired immunodeficiency syndrome (AIDS) is an important global public health problem.By the end of 2017, 36.9 million people were living with human immunodeficiency virus (HIV)infection worldwide, with 1.8 million new infections and 940,000 AIDS-related deaths each year [1].In China, among the newly reported HIV/AIDS cases, the proportion of men who have sex with men (MSM) has been increasing yearly.The proportion of HIV infections transmitted through MSM increased from 3.4% in 2007 to 28% in 2017, and currently, HIV infection is spreading extremely rapidly among MSM in China [2]
The pre-exposure prophylaxis (PrEP) regimen mainly includes the use of tenofovir disoproxil fumarate (TDF) monotherapy or a combination of TDF and emtricitabine (FTC)
Recruitment was performed using the following methods: first, through non-governmental organizations (NGOs) which were established voluntarily by the MSM population, they were mainly responsible for recruitment and cohort maintenance; second, through peer introduction, and by the dissemination of information through announcements at public places and at places of entertainment frequented by the MSM population; third, through voluntary counseling and testing for AIDS (VCT) clinics; fourth, through the Internet
Summary
Acquired immunodeficiency syndrome (AIDS) is an important global public health problem.By the end of 2017, 36.9 million people were living with human immunodeficiency virus (HIV)infection worldwide, with 1.8 million new infections and 940,000 AIDS-related deaths each year [1].In China, among the newly reported HIV/AIDS cases, the proportion of MSM has been increasing yearly.The proportion of HIV infections transmitted through MSM increased from 3.4% in 2007 to 28% in 2017, and currently, HIV infection is spreading extremely rapidly among MSM in China [2]. In China, among the newly reported HIV/AIDS cases, the proportion of MSM has been increasing yearly. The HIV infection situation is serious in this population and needs effective intervention and control Behavioral intervention such as condom use has been proved effective in preventing new HIV infections, the effectiveness of single behavioral intervention is not obvious, and needs the combined biomedical interventions such as PrEP. Pre-exposure prophylaxis (PrEP) is an important biological prevention strategy among MSM. There are limited studies on the medication regimen of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in China. This study compared the effectiveness of and adherence to two prophylactic HIV medication regimens, which provided evidence and guidance for the application and promotion of the PrEP strategy in the MSM population in China. Demographic, behavioral, psychological characteristics and AIDS-related attitudes were assessed using self-completed questionnaires
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