Comparison between daily and on-demand PrEP (pre-exposure prophylaxis) regimen in covering condomless anal intercourse for men who have sex with men in Hong Kong: A randomized, controlled, open-label, crossover trial.
TL;DR: In this paper, a randomized, controlled, open-label, crossover trial was conducted in a teaching hospital in Hong Kong and participants were randomly assigned in a 1:1 ratio with a block size of four to either daily-first or on-demand-first arm based on the IPERGAY study, for receiving PrEP for 16 weeks, then crossed-over to the alternative regimen for another 16 weeks.
Abstract: INTRODUCTION Both daily and on-demand regimens have been proven effective for pre-exposure prophylaxis (PrEP) against HIV in men who have sex with men (MSM). We aimed to compare the two regimens on their coverage of condomless anal intercourse (CLAI) in MSM. METHODS A randomized, controlled, open-label, crossover trial was conducted in a teaching hospital in Hong Kong. Participants were sexually active HIV-negative MSM aged 18 years or above with normal renal function and without chronic hepatitis B infection. Oral tenofovir disoproxil fumarate 300 mg/emtricitabine 200 mg (TDF/FTC) tablets were prescribed for PrEP. After a 2-week lead-in with daily TDF/FTC for treatment-naive MSM for tolerance assessment, participants were randomly assigned in a 1:1 ratio with a block size of four to either daily-first or on-demand-first arm based on the IPERGAY study, for receiving PrEP for 16 weeks, then crossed-over to the alternative regimen for another 16 weeks. The primary outcome was the proportion of days with PrEP-covered CLAI by intention-to-treat analysis. The trial is registered with the CCRB Clinical Trials Registry, CUHK, CUHK_CCRB00606, and is closed to accrual. RESULTS Between 25 August 2018 and 23 March 2019, 119 eligible participants were assigned to daily-first arm (n = 59) and on-demand-first arm (n = 60) with an 87% overall completion rate (n = 103). With 96% and 54% of days on PrEP during daily and on-demand periods, respectively, the proportion of days with PrEP-covered CLAI between two arms were not statistically different (92% vs. 92%, p = 0.93). About half (47%) were diagnosed with at least one episode of incident sexually transmitted infection. Mild and time-limited adverse events, including diarrhoea, headache, nausea and dizziness, were reported in 37 (31%) and 10 (8%) during the daily and on-demand periods, respectively. At the end of the study, a similar proportion favoured daily or on-demand regimen. CONCLUSIONS High prevention-effective adherence, as reflected from the coverage of CLAI, was achievable by either daily or on-demand PrEP among MSM, albeit a higher number of tablets taken for daily PrEP. As both regimens were well accepted, a flexible approach adopting either or both regimens with possible switching is warranted in order to suit individual health needs.
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TL;DR: In this article , a study aimed to pilot-test internet-based HIV and STI testing with self-sampling to enhance engagement of MSM with regular testing, as defined by having made at least 3 visits over a 6-12 months' follow-up period, compared with partial engagement in the bivariable logistic regression model.
Abstract: Background Regular HIV and sexually transmitted infection (STI) testing for men who have sex with men (MSM) is an important means of infection prevention, the adoption of which remains suboptimal in the community. Objective On the hypothesis that engagement plays an important role in sexual health monitoring, this study aimed to pilot-test internet-based HIV and STI testing with self-sampling to enhance engagement of MSM with regular testing. Methods This 1-year cohort study was conducted on HIV-negative MSM aged 18 years or older. A designated website was set up to enable participants to make appointments for baseline and follow-up visits at 3-monthly intervals. On-site blood sampling was performed for HIV and syphilis tests, along with self-collection of pharyngeal swabs, rectal swabs, and urine samples for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing. Full engagement, as defined by having made at least 3 visits over a 6-12 months’ follow-up period, was compared with partial engagement in the bivariable logistic regression model. Results Between August 2019 and October 2020, 204 MSM were recruited, after the exclusion of 2 baseline HIV-positive MSM. The majority (189/204, 92.7%) were Chinese, the median age was 31 (IQR 26-39) years, and 58.0% (116/200) had experience with pre-exposure prophylaxis (PrEP) at baseline. Full engagement (146/204, 71.6%) was associated with incident STI during the follow-ups (odds ratio [OR] 4.23, 95% CI 1.63-10.94), seeking a medical referral after STI detection (OR 10.25, 95% CI 3.25-29.79), and a synchronized schedule of HIV and STI testing with PrEP visits (OR 51.85, 95% CI 19.30-139.34). No incident HIV was detected in the follow-up period. At baseline, the overall STI (CT, NG, or syphilis) prevalence was 30%, with CT at 18%, NG at 13%, and syphilis at 5%. During follow-up, the incidences were 59.08/100 person-years (py) for any STI, 33.05/100 py for CT, 29.86/100 py for NG, and 10.4/100 py for syphilis. The detection rates of CT and NG in urine samples were lower than with pharyngeal swabs and rectal swabs. The scores for convenience, confidence of correct sampling, and accuracy of self-sampling were high (7 to 8 out of 10). Conclusions Both baseline prevalence and incidence of STI were high among MSM engaged in regular testing. A high degree of engagement in regular STI and HIV testing was positively associated with incident STI, history of health-seeking behaviors, and perceived convenience of self-sampling. Self-sampling could be introduced as a means of enhancing engagement in regular HIV and STI testing.
4 citations
TL;DR: Investigating reasons for PrEP disengagement among men who have sex with men attending a sexual health clinic at a large urban academic medical center in New York City found many people lost to follow up still desired PrEP, underscoring the importance of outreach, benefits navigators, and expansion of PrEP into primary care settings.
Abstract: Pre-exposure prophylaxis (PrEP) prevents HIV, but low rates of retention in care limit its effectiveness. We conducted a prospective survey-based study to investigate reasons for PrEP disengagement among men who have sex with men attending a sexual health clinic at a large urban academic medical center in New York City who were lost to follow up; surveys asked about current PrEP status, reasons for disengagement, attitudes toward PrEP, substance use, sexual practices, and behavioral/social determinants of health. Outreach attempts were made to 634 patients; majority of eligible participants were unable to be contacted (59%). Among those who agreed to participate (n = 175), 21% asked to re-establish care. Among those who completed the questionnaire (n = 86), 36% were taking PrEP. The most common reasons for PrEP discontinuation were cost/lack of insurance coverage (31%), decreased HIV risk perception (29%), and side effects (16%). Among those with decreased perception of risk, 62% were less sexually active, 38% were no longer engaging in anal sex, and 31% were using condoms for prevention. Participants reported that free medication (60%), having a sexual partner recommend PrEP (13%), and being able to receive PrEP from a primary care provider (13%) would encourage restarting PrEP. Findings were limited by low response rate (12% of eligible subjects completed the survey) and lack of Spanish-language questionnaires. Understanding reasons for loss-to-PrEP follow-up is essential for HIV prevention. Many people lost to follow up still desired PrEP, underscoring the importance of outreach, benefits navigators, and expansion of PrEP into primary care settings.
4 citations
TL;DR: The qualitative assessment of MSM’s preference for PrEP service delivery has yielded important information on the many facets of a desirable service model.
Abstract: Background Pre-exposure prophylaxis (PrEP) is an effective means of HIV prevention for men who have sex with men (MSM), a key population whose engagement is crucial for achieving effective public health outcomes. An optimal service model would be important in planning the implementation of PrEP in places where such service has not been established. Methods A qualitative study was conducted to delineate the attributes of an optimal PrEP service model for MSM in Hong Kong, a city where no formal PrEP programs existed. Twenty purposively sampled MSM who were enrollees of two pilot PrEP projects participated in the semi-structured interviews promoting story-telling. The coded data were thematically analyzed following Grounded Theory approach, focusing on uncovering a typology of the essential attributes of an optimal PrEP service model, and the reasons for such preferences. Results Participating MSM were all ethnic Chinese and aged 26 to 52 years. All had received PrEP from pilot projects in conjunction with periodic screening of sexually transmitted infections (STI), HIV antibody, and plasma creatinine. Four major themes emerged as regards the attributes of a preferred PrEP service: (i) comprehensiveness of HIV/STI and safety monitoring; (ii) convenient unitary service; (iii) stigma-free PrEP access and protecting confidentiality; and (iv) affordable price. Whereas regular provision of PrEP was acceptable to MSM, unaffordability and related stigma were the anticipated challenges for potential service providers. Conclusions The qualitative assessment of MSM’s preference for PrEP service delivery has yielded important information on the many facets of a desirable service model.
3 citations
TL;DR: In this paper , the effectiveness, safety, adherence, sexually transmitted infections (STIs) dynamics, and frequency of anal dysplasia among a real-life cohort of PrEP users in Northwest Spain were assessed.
Abstract: Introduction Pre-exposure prophylaxis (PrEP) has become a useful tool to reduce the transmission of human immunodeficiency virus (HIV) in key populations. In this article we assessed the effectiveness, safety, adherence, sexually transmitted infections (STIs) dynamics, and frequency of anal dysplasia among a real-life cohort of PrEP users in Northwest Spain. Methods A retrospective cohort study was undertaken in the Alvaro-Cunqueiro Hospital, Vigo which included every individual who started daily emtricitabine/tenofovir-disoproxil-fumarate (FTC/TDF) between November-2019 and October-2021. Clinical and epidemiological data were obtained from the patient's medical records. The effectiveness and safety of FTC/TDF were assessed by HIV serology and renal function monitoring every 3 months. Anal, urethral, and oropharyngeal exudates were collected quarterly after the baseline visit. Results A total of 126 individuals were considered eligible, most of the participants had previously been diagnosed with a STI (60.3%), 22% had consumed recreational drugs in the year prior, and 13% had engaged in chemsex. At the end of the follow-up, no cases of HIV infection were detected; 3 patients had discontinued FTC/TDF because of side effects but none of them had presented renal toxicity. In addition, the diagnosis of STIs during the follow-up was common (100 cases in 54 patients). Moreover, engagement in chemsex was more common within this latter group (22 vs. 6%, p = 0.013). Among the study population included in the anal screening programme, the frequency of dysplasia was 9%. Conclusions FTC/TDF was effective, safe, and tolerable in a real-life cohort; adherence remained high throughout the study period (79%). However, a high number of STIs were diagnosed, especially among patients who engaged in chemsex.
1 citations
TL;DR: In this paper , an individual-based stochastic model of HIV risk in two synthetic MSM populations with parameters separately estimated using data from Harlem, US, and Bangkok, Thailand was created.
1 citations
References
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University of Colorado Denver1, University of California, San Francisco2, Asociación Civil Impacta Salud y Educación3, Oswaldo Cruz Foundation4, Chiang Mai University5, Federal University of Rio de Janeiro6, University of Cape Town7, Brown University8, University of São Paulo9, National Institutes of Health10
TL;DR: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects and Detectable blood levels strongly correlated with the prophylactic effect.
Abstract: The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at en rollment, and 100 became infected during follow-up (36 in the FTC–TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P = 0.005). In the FTC–TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC–TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P = 0.57). Conclusions Oral FTC–TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foun dation; ClinicalTrials.gov number, NCT00458393.)
4,247 citations
TL;DR: The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men, and the treatment was associated with increased rates of gastrointestinal and renal adverse events.
Abstract: Background Antiretroviral preexposure prophylaxis has been shown to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection in some studies, but conflicting results have been reported among studies, probably due to challenges of adherence to a daily regimen.
Methods
We conducted a double-blind, randomized trial of antiretroviral therapy for preexposure HIV-1 prophylaxis among men who have unprotected anal sex with men. Participants were randomly assigned to take a combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or placebo before and after sexual activity. All participants received risk-reduction counseling and condoms and were regularly tested for HIV-1 and HIV-2 and other sexually transmitted infections.
Results
Of the 414 participants who underwent randomization, 400 who did not have HIV infection were enrolled (199 in the TDF-FTC group and 201 in the placebo group). All participants were followed for a median of 9.3 months (interquartile range, 4.9 to 20.6). A total of 16 HIV-1 infections occurred during follow-up, 2 in the TDF-FTC group (incidence, 0.91 per 100 person-years) and 14 in the placebo group (incidence, 6.60 per 100 person-years), a relative reduction in the TDF-FTC group of 86% (95% confidence interval, 40 to 98; P=0.002). Participants took a median of 15 pills of TDF-FTC or placebo per month (P=0.57). The rates of serious adverse events were similar in the two study groups. In the TDF-FTC group, as compared with the placebo group, there were higher rates of gastrointestinal adverse events (14% vs. 5%, P=0.002) and renal adverse events (18% vs. 10%, P=0.03).
Conclusions
The use of TDF-FTC before and after sexual activity provided protection against HIV-1 infection in men who have sex with men. The treatment was associated with increased rates of gastrointestinal and renal adverse events. (Funded by the National Agency of Research on AIDS and Viral Hepatitis [
ANRS] and others; ClinicalTrials.gov number, NCT01473472.)
1,226 citations
TL;DR: PrEP using oral FTC-TDF tablets is a robust intervention for preventing HIV acquisition among men who have sex with men, and specific drug concentrations associated with protection from HIV-1 acquisition in the iPrEx trial are estimated.
Abstract: Drug concentrations associated with protection from HIV-1 acquisition have not been determined. We evaluated drug concentrations among men who have sex with men in a substudy of the iPrEx trial (1). In this randomized placebo-controlled trial, daily oral doses of emtricitabine/tenofovir disoproxil fumarate were used as pre-exposure prophylaxis (PrEP) in men who have sex with men. Drug was detected less frequently in blood plasma and in viable cryopreserved peripheral blood mononuclear cells (PBMCs) in HIV-infected cases at the visit when HIV was first discovered compared with controls at the matched time point of the study (8% versus 44%; P < 0.001) and in the 90 days before that visit (11% versus 51%; P < 0.001). An intracellular concentration of the active form of tenofovir, tenofovir-diphosphate (TFV-DP), of 16 fmol per million PBMCs was associated with a 90% reduction in HIV acquisition relative to the placebo arm. Directly observed dosing in a separate study, the STRAND trial, yielded TFV-DP concentrations that, when analyzed according to the iPrEx model, corresponded to an HIV-1 risk reduction of 76% for two doses per week, 96% for four doses per week, and 99% for seven doses per week. Prophylactic benefits were observed over a range of doses and drug concentrations, suggesting ways to optimize PrEP regimens for this population.
800 citations
TL;DR: Across populations and PrEP regimens, PrEP significantly reduced the risk of HIV acquisition compared with placebo, and there is no evidence of behavioral risk compensation.
Abstract: Objective:
Preexposure prophylaxis (PrEP) offers a promising new approach to HIV prevention. This systematic review and meta-analysis evaluated the evidence for use of oral PrEP containing tenofovir disoproxil fumarate as an additional HIV prevention strategy in populations at substantial risk for HIV based on HIV acquisition, adverse events, drug resistance, sexual behavior, and reproductive health outcomes.
679 citations
TL;DR: On-demand oral PrEP is highly effective at preventing HIV infection among high-risk men who have sex with men and therefore represents an alternative to daily PrEP, expanding choices for HIV prevention.
348 citations