ABSTRACT
This guideline offers recommendations on the diagnosis, treatment and health promotion principles needed for the effective management of human papillomavirus (HPV)-related warts at anogenital sites including the external genitals, vagina, cervix, urethra, perianus and anal canal. The guideline is aimed primarily at patients aged 16 years or older presenting to healthcare professionals working in level 3 sexual health services in the United Kingdom. However, the principles of the recommendations may be applied in other care settings, including in primary care, using locally adapted care pathways where appropriate. The management of HPV-related anogenital dysplasia or warts at other extragenital sites is outside the scope of this guideline.
Subject(s)
Condylomata Acuminata , Sexual Health , Adolescent , Adult , Female , Humans , Male , Condylomata Acuminata/therapy , Condylomata Acuminata/diagnosis , Papillomavirus Infections/diagnosis , Papillomavirus Infections/therapy , Practice Guidelines as Topic , United KingdomSubject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Sexual Health , Sexual and Gender Minorities , Humans , Male , London , HIV Infections/diagnosis , HIV Infections/prevention & control , HIV Infections/drug therapy , Homosexuality, Male , HIV Testing , Sexual Behavior , Anti-HIV Agents/therapeutic useABSTRACT
Oral PrEP's effectiveness relies on adequate adherence during periods of substantial HIV risk. Since most PrEP users will miss doses, understanding predictors within participants can help to explain adherence. We used a cross-sectional, within-participant design with 67 gay, bisexual, and other men who have sex with men taking PrEP daily. Using a questionnaire, informed by the Information Motivation Behavioral Skills Model, participants were asked about an adherent and a non-adherent episode. PrEP non-adherence was associated with non-normality of the day (p < .001), being out of the home (p < .001), weekend days (p = .01), having company (p = .02), using substances (p = 0.02), not using reminders (p = .03), lower PrEP information (p = .04), lower behavioural skills (p < .001) and less positive affect (p = .002). PrEP adherence assessment could focus on situational variations, supporting the construction of alternative strategies to facilitate adherence in these situations.
Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Male , Humans , Homosexuality, Male/psychology , HIV Infections/psychology , Cross-Sectional Studies , Medication AdherenceABSTRACT
OBJECTIVE: We present findings from a large cohort of individuals treated during primary HIV infection (PHI) and examine the impact of time from HIV-1 acquisition to antiretroviral therapy (ART) initiation on clinical outcomes. We also examine the temporal changes in the demographics of individuals presenting with PHI to inform HIV-1 prevention strategies. METHODS: Individuals who fulfilled the criteria of PHI and started ART within 3 months of confirmed HIV-1 diagnosis were enrolled between 2009 and 2020. Baseline demographics of those diagnosed between 2009 and 2015 (before preexposure prophylaxis (PrEP) and universal ART availability) and 2015-2020 (post-PrEP and universal ART availability) were compared. We examined the factors associated with immune recovery and time to viral suppression. RESULTS: Two hundred four individuals enrolled, 144 from 2009 to 2015 and 90 from 2015 to 2020; median follow-up was 33âmonths. At PHI, the median age was 33âyears; 4% were women, 39% were UK-born, and 84% were MSM. The proportion of UK-born individuals was 47% in 2009-2015, compared with 29% in 2015-2020. There was an association between earlier ART initiation after PHI diagnosis and increased immune recovery; each day that ART was delayed was associated with a lower likelihood of achieving a CD4 + cell count more than 900âcells/µl [hazard ratio 0.99 (95% confidence interval, 95% CI 0.98-0.99), P â=â0.02) and CD4/CD8 more than 1.0 (hazard ratio 0.98 (95% CI 0.97-0.99). CONCLUSION: Early initiation of ART at PHI diagnosis is associated with enhanced immune recovery, providing further evidence to support immediate ART in the context of PHI. Non-UK-born MSM accounts for an increasing proportion of those with primary infection; UK HIV-1 prevention strategies should better target this group.
Subject(s)
Anti-HIV Agents , HIV Infections , HIV Seropositivity , HIV-1 , Sexual and Gender Minorities , Male , Humans , Female , Adult , HIV Infections/drug therapy , Homosexuality, Male , CD4 Lymphocyte Count , HIV Seropositivity/drug therapy , Anti-HIV Agents/therapeutic use , Antiretroviral Therapy, Highly ActiveABSTRACT
BACKGROUND: Chemsex (the use of psychoactive drugs in sexual contexts) has been associated with HIV acquisition and other STIs, so there is benefit in identifying those most likely to start chemsex to offer risk reduction interventions such as pre-exposure prophylaxis (PrEP). To date, there have been no data from a longitudinal study analysing factors most associated with starting and stopping chemsex. METHODS: The prospective cohort study, Attitudes to and Understanding Risk of Acquisition of HIV over Time (AURAH2), collected 4 monthly and annual online questionnaire data from men who have sex with men (MSM) from 2015 to 2018. We investigate the association of sociodemographic factors, sexual behaviours and drug use with starting and stopping chemsex among 622 men who completed at least one follow-up questionnaire. Poisson models with generalised estimating equations were used to produce risk ratios (RRs) accounting for multiple starting or stopping episodes from the same individual. Multivariable analysis was adjusted for age group, ethnicity, sexual identity and university education. FINDINGS: In the multivariable analysis, the under 40 age group was significantly more likely to start chemsex by the next assessment (RR 1.79, 95% CI 1.12 to 2.86). Other factors which showed significant association with starting chemsex were unemployment (RR 2.10, 95% CI 1.02 to 4.35), smoking (RR 2.49, 95% CI 1.63 to 3.79), recent condomless sex (CLS), recent STI and postexposure prophylaxis (PEP) use in the past year (RR 2.10, 95% CI 1.33 to 3.30). Age over 40 (RR 0.71, 95% CI 0.51 to 0.99), CLS, and use of PEP (RR 0.64, 95% CI 0.47 to 0.86) and PrEP (RR 0.47, 95% CI 0.29 to 0.78) were associated with lower likelihood of stopping chemsex by the next assessment. INTERPRETATION: Knowledge of these results allows us to identify men most likely to start chemsex, thus providing an opportunity for sexual health services to intervene with a package of risk mitigation measures, especially PrEP use.
Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Sexually Transmitted Diseases , Male , Humans , Homosexuality, Male , Prospective Studies , HIV Infections/prevention & control , Longitudinal Studies , Sexual Behavior , Sexually Transmitted Diseases/epidemiology , Sexually Transmitted Diseases/prevention & control , England/epidemiology , Surveys and Questionnaires , Pre-Exposure Prophylaxis/methodsABSTRACT
INTRODUCTION: A key part of the response to the mpox (monkeypox) epidemic has been the vaccination campaign targeted at gay, bisexual and other men who have sex with men (GBM), including people living with HIV (PLWH). METHODS: We undertook a single-site, retrospective analysis of individuals who received a single dose of modified vaccinia Ankara (MVA-BN) prior to the onset of mpox symptoms. Demographics, clinical characteristics and patient management were analysed. RESULTS: Of 10 068 individuals who received a first dose of the MVA-BN vaccination, 15 (0.15%) developed mpox subsequently. All individuals identified were GBM with 12/15 (80%) on Pre-exposure prophylaxis (PrEP) and 3/15 (20%) PLWH. Median time from MVA-BN inoculum to mpox symptoms was 4 days (IQR 3-9), systemic symptoms and supportive medical treatment required were common (11/15 patients, 73%) and all had localising skin lesions. One individual required hospitalisation. CONCLUSIONS: Although clinical presentation was similar to unvaccinated cohorts, we observed low numbers of mpox cases following a first dose of MVA-BN vaccination. Larger, multicentric studies are needed to further evaluate vaccination failure and immunity duration.
Subject(s)
Mpox (monkeypox) , Sexual and Gender Minorities , Vaccinia , Male , Humans , Vaccinia/prevention & control , Homosexuality, Male , Retrospective Studies , Vaccinia virus , Vaccination , ImmunizationABSTRACT
We describe 2 cases of infectious proctitis secondary to human monkeypox in patients presenting with rectal pain. These cases highlight the importance of multidisciplinary management of monkeypox and in expanding case definitions and enabling clinical recognition in patients presenting without skin rash.
Subject(s)
Exanthema , Intraabdominal Infections , Mpox (monkeypox) , Proctitis , Humans , Proctitis/diagnosis , Proctitis/drug therapy , PainABSTRACT
OBJECTIVES: Outbreaks of bacterial enteric pathogens (BEPs) in men who have sex with men (MSM) associated with antimicrobial resistance are a public health concern. We investigated the prevalence and risk factors of BEPs in MSM to inform infection control. METHODS: We conducted a cross-sectional study at a London sexual health clinic between 20/12/2017 and 06/02/2018. Residual rectal swabs from MSM attending for sexually transmitted infection (STI) testing were anonymously tested for a range of BEPs using real-time PCR. A sub-set of samples were tested for the mphA gene (a marker of azithromycin resistance). Results were linked to electronic health records. RESULTS: BEPs were detected in 207 of 2116 participants, giving an overall prevalence of 9.8% (95% CI 8.5%-11.1%) ranging from 0.8% (0.4%-1.2%) for Shigella to 4.9% (4.0%-5.9%) for Enteroaggregative E. coli. MSM with BEPs were more likely to have a history of bacterial STIs (p = 0.010), to report more sexual partners (p<0.001), and among HIV-negative MSM, to report current HIV pre-exposure prophylaxis use (p<0.001). Gastrointestinal symptoms were rare (1.7%) and not associated with BEPs. 41.3% of MSM with BEPs and 14.1% of those without BEPs carried mphA (p<0.001). Among the former, this was associated with a history of bacterial STIs (51.5% vs 31.1%, p = 0.003). CONCLUSIONS: One in ten MSM had a BEP detected and most did not report symptoms. MphA carriage was common, particularly among those with BEPs. Bacterial STI treatment might contribute to selection of resistant gut organisms, emphasising the need for better antimicrobial stewardship.
Subject(s)
HIV Infections , Sexual and Gender Minorities , Sexually Transmitted Diseases , Male , Humans , Homosexuality, Male , Cross-Sectional Studies , Sexual Behavior , HIV Infections/complications , Escherichia coli , Prevalence , Sexually Transmitted Diseases/epidemiology , Risk Factors , Sexual Partners , London/epidemiology , Health ServicesABSTRACT
BACKGROUND: Historically, human monkeypox virus cases in the UK have been limited to imported infections from west Africa. Currently, the UK and several other countries are reporting a rapid increase in monkeypox cases among individuals attending sexual health clinics, with no apparent epidemiological links to endemic areas. We describe demographic and clinical characteristics of patients diagnosed with human monkeypox virus attending a sexual health centre. METHODS: In this observational analysis, we considered patients with confirmed monkeypox virus infection via PCR detection attending open-access sexual health clinics in London, UK, between May 14 and May 25, 2022. We report hospital admissions and concurrent sexually transmitted infection (STI) proportions, and describe our local response within the first 2 weeks of the outbreak. FINDINGS: Monkeypox virus infection was confirmed in 54 individuals, all identifying as men who have sex with men (MSM), with a median age of 41 years (IQR 34-45). 38 (70%) of 54 individuals were White, 26 (48%) were born in the UK, and 13 (24%) were living with HIV. 36 (67%) of 54 individuals reported fatigue or lethargy, 31 (57%) reported fever, and ten (18%) had no prodromal symptoms. All patients presented with skin lesions, of which 51 (94%) were anogenital. 37 (89%) of 54 individuals had skin lesions affecting more than one anatomical site and four (7%) had oropharyngeal lesions. 30 (55%) of 54 individuals had lymphadenopathy. One in four patients had a concurrent STI. Five (9%) of 54 individuals required admission to hospital, mainly due to pain or localised bacterial cellulitis requiring antibiotic intervention or analgesia. We recorded no fatal outcomes. INTERPRETATION: Autochthonous community monkeypox virus transmission is currently observed among MSM in the UK. We found a high proportion of concomitant STIs and frequent anogenital symptoms, suggesting transmissibility through local inoculation during close skin-to-skin or mucosal contact, during sexual activity. Additional resources are required to support sexual health and other specialist services in managing this condition. A review of the case definition and better understanding of viral transmission routes are needed to shape infection control policies, education and prevention strategies, and contact tracing. FUNDING: None.
Subject(s)
Mpox (monkeypox) , Sexual Health , Sexual and Gender Minorities , Sexually Transmitted Diseases , Adult , Demography , Homosexuality, Male , Humans , London , Male , Middle Aged , Monkeypox virus , Observational Studies as Topic , Sexual BehaviorABSTRACT
OBJECTIVES: Disruption to sexual health services during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2; coronavirus disease 2019 [COVID-19]) pandemic may have adversely affected the provision of HIV post-exposure prophylaxis (PEP), possibly leading to increased HIV transmission. Globally, services have reported a reduction in the number of PEP prescriptions dispensed during lockdowns, although it is unclear why. Our primary objective was to describe the temporal change in weekly HIV PEP dispensed at six English sexual health clinics in 2020. METHODS: We performed a cross-sectional review of PEP prescriptions from six English centres during 2020. RESULTS: During 2020, 2884 PEP prescriptions were dispensed across the six centres studied, a fall of 34.5% from the 4403 PEP prescriptions in 2019. Before the COVID-related lockdown in 2020, the PEP dispensed was stable at 82.5 per week. Following the first lockdown, this fell to a nadir of 13 in week 14 (Figure 1). Prescriptions rose to a peak of 79 in week 37 and then declined to 32 prescriptions in the last week of 2020. There was no difference in the following characteristics of PEP recipients before and during the first lockdown: age, ethnicity, country of birth or the service the recipient attended. CONCLUSION: Whatever the reason for the fall in PEP seen in England over 2020, it is essential that HIV testing and access to HIV prevention is maintained for those in need.
Subject(s)
COVID-19 , HIV Infections , Sexual Health , COVID-19/prevention & control , Communicable Disease Control , Cross-Sectional Studies , HIV Infections/drug therapy , HIV Infections/prevention & control , Humans , Post-Exposure Prophylaxis , SARS-CoV-2ABSTRACT
OBJECTIVES: In January 2021, 56 Dean Street, a London sexual health clinic, changed clinic policy so that all those attending for post-exposure prophylaxis (PEP) were offered quick-start opt-out pre-exposure prophylaxis (PrEP) following completion of the 28-day PEP course. We assessed the uptake of this quick-start PrEP in service users attending for PEP. METHODS: We undertook a case note review of those who received PEP during the 2-week period from 17 February to 1 March 2021, assessing the data and comparing them to those from the same period in 2020 (15 February-28 February 2020) before quick-start opt-out PrEP was introduced. RESULTS: The number of service users receiving PEP was 82 in 2020 and 42 in 2021, of which an unmet PrEP need was demonstrated in 81.7% (67/82) in 2020 and 78.6% (33/42) in 2021 (p = 0.8106). Of those with an unmet need, a higher proportion (97.0% [32/33]) were offered PrEP in 2021 following the introduction of opt-out PrEP compared with the 85.1% (57/67) in 2020 (p = 0.0953). Of those eligible for PrEP who were offered it during their PEP consultation, 53.1% (17/32) in 2021 were dispensed PrEP compared with 17.5% (10/57) in 2020 (p = 0.0007). CONCLUSION: Since the introduction of quick-start opt-out PrEP, uptake in eligible candidates increased from 17.5% to 53.1%. This suggests that this strategy was acceptable to service users.
Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Ambulatory Care Facilities , Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/prevention & control , Homosexuality, Male , Humans , Male , Post-Exposure ProphylaxisABSTRACT
INTRODUCTION: HIV-1 pre-exposure prophylaxis (PrEP) has been available in England since March 2020 on the National Health Service using generic emtricitabine and tenofovir disoproxil. 56 Dean Street (56DS) provided PrEP through (1) additional private care from September 2015, estimated to be providing 11% of England's PrEP in 2019; and (2) the IMPACT trial, as well as monitoring those self-sourcing PrEP. Providing PrEP at scale through a nurse-led service required a safety net for complex individuals. 56DS introduced a consultant-led PrEP outpatient service, the PrEP review clinic, in January 2018 and we report the outcomes of this service. METHODS: We present a retrospective case note review of the PrEP review clinic with descriptive outcomes from 26 January 2018 to 20 December 2019. Reason for referral, demographics, PrEP management and PrEP discontinuations were recorded. RESULTS: 13 980 unique users accessed PrEP from 56DS during the two year evaluation period. 220 individuals were seen in the PrEP review clinic. Majority of patients were referred for renal issues (114 of 220, 51.8%), followed by side effects (59 of 220, 26.8%) and comorbidities (38 of 220, 17.2%). Of those with renal issues, 89 (out of 114, 78.1%) users were referred for an abnormal estimated glomerular filtration rate (eGFR). 35 (out of 114, 30.7%) PrEP users had an eGFR between 45 and 59 mL/min/1.73 m2, of whom 2 (5.7%) discontinued PrEP. Majority of users were advised to stop supplements±switch to event-based dosing (24 of 35, 68.6%). Ten PrEP users were referred with an eGFR between 30 and 44 mL/min/1.73 m2; 4 (40%) stopped or did not start PrEP and 6 (60%) were asked to stop supplements±switch to event-based dosing. DISCUSSION: A small proportion of PrEP users have complex PrEP issues. Methods to manage renal dysfunction with PrEP included stopping supplements and switching to event-based dosing. Those with side effects were managed with an array of options, with only modest effectiveness. Other PrEP options are needed to support those with toxicities or intolerances.
Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Humans , Retrospective Studies , Consultants , State Medicine , HIV Infections/prevention & control , HIV Infections/drug therapy , Pre-Exposure Prophylaxis/methodsABSTRACT
INTRODUCTION: Preexposure prophylaxis (PrEP) is contributing to achieve a reduction in HIV diagnoses in men having sex with men (MSM). Albeit infrequent, HIV infections in the context of recent PrEP exposure represent a clinical challenge. METHODS: Data on recent PrEP use and possible reasons leading to HIV infection were analysed in individuals newly diagnosed with HIV at 56 Dean Street clinic in 2016-2020. Demographics, immune-virological parameters, genotypic resistance test results and treatment management in this group were compared with those not reporting recent PrEP exposure using Mann-Whitney U test and Fisher's exact test. RESULTS: Fifty-two of 1030 (5%) individuals reported recent PrEP exposure at HIV diagnosis; 98% were MSM, median age 34âyears (interquartile range [IQR] 28-42), 65% of white ethnicity, 65% non-UK-born. 35% reported PrEP intake the day before testing HIV positive, 46% reported sub-optimal PrEP adherence since their last negative HIV test result. Thirty-three of 52 (63%) were self-sourcing PrEP and 9/52 (17%) reported issues with its supply. Recent PrEP use was associated to lower HIV viral load and higher CD4+ cell count at baseline than in counterparts non-recently exposed to PrEP (Pâ<â0.01). M184V mutation was harboured more commonly in the recent PrEP use group (30% vs. 1%, Pâ<â0.01). The proportion of individuals recently exposed to PrEP among those diagnosed with HIV rose sharply, reaching 21% in the first semester of 2020. Viral suppression was achieved by all patients intensified from PrEP to antiretroviral treatment (ART) who remained in care at week 24. DISCUSSION: Rapid PrEP intensification to ART allowed to achieve high rates of HIV viral suppression despite significant rates of M184V mutation harboured in those newly diagnosed with HIV and reporting recent PrEP exposure.
Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Adult , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , HIV Infections/drug therapy , HIV Infections/prevention & control , Homosexuality, Male , Humans , Male , Pre-Exposure Prophylaxis/methods , Treatment OutcomeABSTRACT
BACKGROUND: Primary syphilis is characterised by the appearance of an ulcerated lesion (chancre) on the anogenital or oral mucosa from which Treponema pallidum DNA may be detectable by PCR. Serological tests for syphilis may be non-reactive in early infection, even after the appearance of a chancre. We reviewed the use of a multiplex-PCR (M-PCR) test to determine the added value of T. pallidum DNA detection in the management of individuals presenting with mucocutaneous ulceration at a sexual health service in central London. METHODS: We performed a cross-sectional analysis of all individuals with detectable T. pallidum DNA from September 2019 to April 2020. Electronic patient records were reviewed and concomitant results for treponemal serology and/or rapid plasma reagin (RPR) extracted, along with demographic data, history of syphilis and indices of sexual behaviour including number of sexual partners contacted. Any subsequent treponemal serology and RPR results were also reviewed. RESULTS: M-PCR swab specimens were performed in 450 individuals, of whom 63 (14%) had detectable T. pallidum DNA; 60 of 63 (95%) were gay or bisexual men and 11 of 63 (17%) were living with HIV. A history of treated syphilis was present in 17 of 63 (27%). Same-day treponemal serology/RPR testing was performed in 58 of 63 (92%) patients. Of the 58 who had same-day syphilis serology/RPR, 9 (16%) had their syphilis infection confirmed by treponemal DNA PCR alone. A total of 165 partners were traced as contacts of infection, of whom 25 (15%) were contacts of individuals diagnosed by M-PCR testing alone. CONCLUSION: In individuals with T. pallidum PCR-positive lesions, around one in six in our cohort were negative on standard diagnostic serological tests for syphilis. Treponemal DNA testing is an important addition to serological assays in individuals with mucocutaneous ulceration who are at risk of recent syphilis infection and facilitates early diagnosis and contact tracing.
Subject(s)
Chancre , Skin Diseases , Syphilis , Cross-Sectional Studies , Humans , Male , Polymerase Chain Reaction/methods , Syphilis/complications , Syphilis Serodiagnosis/methods , Treponema pallidum/genetics , Ulcer/complications , Ulcer/diagnosisABSTRACT
INTRODUCTION: Chemsex in a European context is the use of any of the following drugs to facilitate sex: crystal methamphetamine, mephedrone and gamma-hydroxybutyrate (GHB)/gamma-butyrolactone (GBL) and, to a lesser extent, cocaine and ketamine. This study describes the prevalence of self-reported recreational drug use and chemsex in HIV-positive men who have sex with men (MSM) accessing HIV services in four countries. It also examines the problematic impacts and harms of chemsex and access to chemsex-related services. METHODS: This is a cross-sectional multi-centre questionnaire study of HIV-positive MSM accessing nine HIV services in the UK, Spain, Greece and Italy. RESULTS: In all, 1589 HIV-positive MSM attending HIV services in four countries completed the questionnaire. The median age of participants was 38 years (interquartile range: 32-46 years) and 1525 (96.0%) were taking antiretroviral therapy (ART). In the previous 12 months, 709 (44.6%) had used recreational drugs, 382 (24.0%) reported chemsex and 104 (6.5%) reported injection of chemsex-associated drugs ('slamsex'). Of the 382 engaging in chemsex, 155 (40.6%) reported unwanted side effects as a result of chemsex and 81 (21.2%) as a result of withdrawal from chemsex. The reported negative impacts from chemsex were on work (25.1%, 96), friends/family (24.3%, 93) and relationships (28.3%, 108). Fifty-seven (14.9%) accessed chemsex-related services in the past year, 38 of whom (67%) felt the service met their needs. DISCUSSION: A quarter of participants self-reported chemsex in the past 12 months. There were high rates of harms from chemsex across all countries, including negative impacts on work, friends/family and relationships. Although a minority of those engaging in chemsex accessed support, most found this useful.
Subject(s)
HIV Infections , Illicit Drugs , Sexual and Gender Minorities , Substance-Related Disorders , Adult , Cross-Sectional Studies , HIV Infections/drug therapy , HIV Infections/epidemiology , Homosexuality, Male , Humans , Illicit Drugs/adverse effects , Male , Middle Aged , Sexual Behavior , Substance-Related Disorders/epidemiologyABSTRACT
The 56 Dean Street combination prevention model, a strong engagement with the LGBTQI community and flexible services adapted to users' changing needs led to an 80% drop in HIV diagnoses in gay, bisexual and other men who have sex with men (GBMSM) from 2015 to 2017. We describe the service changes at 56 Dean Street since 2012 which resulted in an increase in the frequency of HIV testing, the introduction of pre-exposure prophylaxis, earlier HIV diagnosis and a shorter time to viral suppression in those living with HIV. This model could be adapted to deliver similar results in those settings of high HIV prevalence among GBMSM and where access to technological innovation in healthcare and engagement with the community can be achieved.
Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Bisexuality , HIV Infections/drug therapy , Homosexuality, Male , Humans , Male , Pre-Exposure Prophylaxis/methodsABSTRACT
BACKGROUND: In DISCOVER, a multinational, randomised controlled trial, emtricitabine and tenofovir alafenamide compared with emtricitabine and tenofovir disoproxil fumarate showed non-inferior efficacy for HIV prevention and improved bone mineral density and renal safety biomarkers at week 48. We report outcomes analysed after all participants had completed 96 weeks of follow-up. METHODS: This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in Europe and North America. Adult cisgender men and transgender women who have sex with men, both with a high risk of acquiring HIV as determined by self-reported sexual behaviour or recent sexually transmitted infections, were randomly assigned (1:1) to receive either emtricitabine and tenofovir alafenamide (200/25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine and tenofovir disoproxil fumarate (200/300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). The primary efficacy outcome was incident HIV infection. Incidence of HIV-1 infection per 100 person-years was assessed when the last participant had completed 96 weeks of follow-up. This trial is registered with ClinicalTrials.gov, number NCT02842086. FINDINGS: Between Sept 13, 2016, and June 30, 2017, 5387 participants were randomly assigned to receive emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693), contributing 10 081 person-years of follow-up. At 96 weeks of follow-up, there were eight HIV infections in participants who had received emtricitabine and tenofovir alafenamide (0·16 infections per 100 person-years [95% CI 0·07-0·31]) and 15 in participants who had received emtricitabine and tenofovir disoproxil fumarate (0·30 infections per 100 person-years [0·17-0·49]). Emtricitabine and tenofovir alafenamide maintained its non-inferiority to emtricitabine and tenofovir disoproxil fumarate for HIV prevention (IRR 0·54 [95% CI 0·23-1·26]). Approximately 78-82% of participants reported taking study medication more than 95% of the time across all study visits. Rates of sexually transmitted infections remained high and similar across groups (21 cases per 100 person-years for rectal gonorrhoea and 28 cases per 100 person-years for rectal chlamydia). Emtricitabine and tenofovir alafenamide continued to show superiority over emtricitabine and tenofovir disoproxil fumarate in all but one of the six prespecified bone mineral density and renal biomarkers. There was more weight gain among participants who had received emtricitabine and tenofovir alafenamide (median weight gain 1·7 kg vs 0·5 kg, p<0·0001). INTERPRETATION: Emtricitabine and tenofovir alafenamide is safe and effective for longer-term pre-exposure prophylaxis in cisgender men and transgender women who have sex with men. FUNDING: Gilead Sciences.
Subject(s)
Adenine/analogs & derivatives , Alanine/therapeutic use , Anti-HIV Agents/therapeutic use , Emtricitabine/therapeutic use , HIV Infections/prevention & control , Organophosphonates/therapeutic use , Tenofovir/therapeutic use , Adenine/adverse effects , Adenine/therapeutic use , Adult , Aged , Alanine/adverse effects , Anti-HIV Agents/adverse effects , Double-Blind Method , Drug Therapy, Combination/adverse effects , Emtricitabine/adverse effects , Female , Follow-Up Studies , HIV Infections/virology , HIV-1/drug effects , HIV-1/physiology , Humans , Male , Middle Aged , Organophosphonates/adverse effects , Pre-Exposure Prophylaxis , Tenofovir/adverse effects , Treatment Outcome , Young AdultSubject(s)
Chlamydia Infections/epidemiology , Gonorrhea/epidemiology , HIV Infections/epidemiology , Pre-Exposure Prophylaxis/statistics & numerical data , Syphilis/epidemiology , Adult , Chlamydia Infections/prevention & control , Chlamydia Infections/psychology , Chlamydia Infections/transmission , Gonorrhea/prevention & control , Gonorrhea/psychology , Gonorrhea/transmission , HIV Infections/prevention & control , HIV Infections/psychology , HIV Infections/transmission , Homosexuality, Male/psychology , Humans , London/epidemiology , Male , Rectum/microbiology , Rectum/virology , Retrospective Studies , Risk Factors , Syphilis/prevention & control , Syphilis/psychology , Syphilis/transmissionABSTRACT
OBJECTIVES: Penicillin-based antibiotic treatment for syphilis infection with CNS involvement (early neurosyphilis) is not always a suitable treatment option. We compared outcomes of patients diagnosed with early neurosyphilis and treated with doxycycline or procaine G penicillin. METHODS: Serological and clinical outcomes were analysed in patients diagnosed with early neurosyphilis between January 2015 and October 2019 at 56 Dean Street, a combined sexual health and HIV service based in London, UK. Acute onset of CNS, ocular and/or otic symptomatology and a documented seroconverting syphilis serology or a >4-fold increase in rapid plasma reagin ('RPR)' test titre within the previous 12 months were criteria used to define a case. Mann-Whitney U-test and χ2 tests were used to test distributions between baseline characteristics and outcomes according to treatment administered. RESULTS: Eighty-seven patients were included: median age = 35 years (IQR = 31-45), 98% MSM, 79% white ethnicity, 53% HIV-1 positive and 40% previously diagnosed with syphilis at any stage. They were treated exclusively with either intramuscular (IM) procaine G penicillin (71%) or oral doxycycline (18%). Patients received doxycycline treatment over a penicillin-based regimen due to IM treatment declined (31%), inability to attend for IM injections (31%) or penicillin allergy (19%). Serological response was achieved by all patients; 91% reported full symptom resolution at 30 days from end of treatment. Similar rates of clinical and serological response and seroreversion were observed in the groups treated with procaine G penicillin versus doxycycline. CONCLUSIONS: The clinical and serological outcomes seen with penicillin-based versus doxycycline treatments were similar. A randomized controlled trial is needed to establish the effectiveness of doxycycline in the treatment of early neurosyphilis.