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Background Direct-acting antiviral (DAA) therapy for hepatitis C virus (HCV) is well tolerated, cost-effective, and yields high sustained virologic response rates, yet it has remained financially inaccessible to many patients. Methods Participants of the Women's Interagency HIV Study (an observational US cohort) with human immunodeficiency virus (HIV) and HCV (RNA+) reporting no prior hepatitis C treatment were followed for DAA initiation (2015–2019). We estimated risk ratios (RRs) of the relationship between time-varying health insurance status and DAA initiation, adjusting for confounders with stabilized inverse probability weights. We also estimated weighted cumulative incidences of DAA initiation by health insurance status. Results A total of 139 women (74% Black) were included; at baseline, the median age was 55 years and 86% were insured. Most had annual household incomes ≤$18 000 (85%); advanced liver fibrosis (21%), alcohol use (45%), and recreational drug use (35%) were common. Across 439 subsequent semiannual visits, 88 women (63%) reported DAA initiation. Compared with no health insurance, health insurance increased the likelihood of reporting DAA initiation at a given visit (RR, 4.94; 95% confidence limit [CL], 1.92 to 12.8). At 2 years, the weighted cumulative incidence of DAA initiation was higher among the insured (51.2%; 95% CL, 43.3% to 60.6%) than the uninsured (3.5%; 95% CL, 0.8% to 14.6%). Conclusions Accounting for clinical, behavioral, and sociodemographic factors over time, health insurance had a substantial positive effect on DAA initiation. Interventions to increase insurance coverage should be prioritized to increase HCV curative therapy uptake for persons with HIV.

In preparation for the 2021 Centers for Disease Control and Prevention (CDC) sexually transmitted infections (STIs) treatment guidelines, the CDC convened an advisory group in 2019 to examine recent literature addressing updates in the epidemiology, diagnosis, and management of STIs. This article summarizes recent data in each of these key topic areas as they pertain to bacterial vaginosis (BV), the most common cause of vaginal discharge. The evidence reviewed primarily focused on updates in the global epidemiology of BV, risk factors for BV, data supportive of sexual transmission of BV-associated bacteria, BV molecular diagnostic tests, and novel treatment regimens. Additionally, recent literature on alcohol abstinence in the setting of 5-nitroimidazole use was reviewed.

Background Disseminated gonococcal infections (DGIs) are thought to be uncommon; surveillance is limited, and case reports are analyzed retrospectively or in case clusters. We describe the population-level burden of culture-confirmed DGIs through the Active Bacterial Core surveillance (ABCs) system. Methods During 2015–2016, retrospective surveillance was conducted among residents in 2 ABCs areas and prospectively in 3 ABCs areas during 2017–2019. A DGI case was defined as isolation of Neisseria gonorrhoeae from a normally sterile site. A case report form was completed for each case and antimicrobial susceptibility testing (AST) was performed on available isolates. Results During 2015–2019, 77 DGI cases were identified (a rate of 0.13 cases per 100 000 population) and accounted for 0.06% of all reported gonorrhea cases in the 3 surveillance areas. Most DGI cases were male (64%), non-Hispanic Black (68%), and ranged from 16 to 67 years of age; blood (55%) and joint (40%) were the most common sterile sites. Among 29 isolates with AST results during 2017–2019, all were susceptible to ceftriaxone. Conclusions DGI is an infrequent complication of N gonorrhoeae; because it can quickly develop antimicrobial resistance, continued DGI surveillance, including monitoring trends in antimicrobial susceptibility, could help inform DGI treatment recommendations.

Otosyphilis can be challenging to diagnose, but, if left unrecognized, it may cause irreversible damage. An immunologic interplay between syphilis and human immunodeficiency virus (HIV) makes coinfection likely and may predispose people with HIV to neurosyphilis. In this study, we present a case of a man in his 50s with hearing loss and vertigo diagnosed with otosyphilis as well as a new diagnosis of HIV. This case and corresponding discussion serve to inform the noninfectious disease-trained clinician of the symptoms, diagnostics, and treatment options for otosyphilis as well as to discuss the relationship between HIV and syphilis and demonstrate the importance of disease recognition.

Background Treponema pallidum (T. pallidum) is transmitted from person to person by direct contact with widespread dissemination early after acquisition. Current syphilis diagnostic testing is limited to darkfield microscopy from visible lesions and serologic antibody detection. T. pallidum molecular diagnostics are urgently needed. Methods As part of a multicenter US syphilis treatment trial that completed enrollment in March 2022 (NCT 3637660), we randomized 249 adults with early syphilis infection to 1 vs 3 weekly doses of benzathine penicillin G to compare treatment response at 6 months. In a small substudy (n=32) presented here, consenting participants at the University of Alabama at Birmingham (UAB) and Emory University had pre-treatment oral (buccal mucosa and posterior pharynx) and lesion swab samples collected. Following DNA extraction, T. pallidum burden in samples was quantified by targeting the tp0574 gene. Syphilis was staged by experienced providers according to physical examination and serology. Results Study participants were men (100%) and most were living with HIV (91%) with mean CD4 count 477 cells/mm3. Syphilis stage was categorized as primary in 6 (19%), secondary in 18 (56%) and early latent in 8 (25%). Oral swab qPCR positivity rates were 17% in primary disease, 44% in secondary disease, and 63% in early latent disease (see Figure). Lesion PCR positivity was similar in primary and secondary syphilis (40% and 38.5%). Mean treponemal burden was highest on oral swabs of participants with early latent syphilis (13,128,969) and lesion swabs of participants with secondary syphilis (2,033,309). Conclusion Among adult males, many living with HIV, data suggest a role for oral and lesion swabs for the molecular detection of T. pallidum. Widespread availability of PCR, the relative ease of oral specimen collection, and the opportunity to directly demonstrate T. pallidum in persons with early latent syphilis suggest the opportunity for PCR testing to enhance and refine syphilis diagnostic testing. The elevated proportion of positive oral samples and significant organism burden in secondary and early latent syphilis is consistent with potential for transmission. Disclosures All Authors: No reported disclosures.

Summary 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 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.

Among 865 adults with early syphilis considered for a multicenter treatment trial, 234 (27%) were excluded before enrollment because of bacterial sexually transmitted infection coinfection. Coinfection with Neisseria gonorrhoeae (29%), Chlamydia trachomatis (22%), or both (23%) was common. Study findings highlight the need for comprehensive bacterial sexually transmitted infection screening in patients with syphilis.

Background Enteric pathogens are often associated with exposure to food, water, animals, and feces from infected individuals. However, in sexual networks of men who have sex with men (MSM), transmission of enteric pathogens may occur during direct or indirect oral–anal contact. Methods We performed a scoping review of the literature for studies prior to July 2019 with key terms for gastrointestinal syndromes (“proctitis,” “enteritis,” “proctocolitis”), enteric pathogens or sexually transmitted infections (STIs), and outbreaks using multiple electronic databases. Results We identified 5861 records through database searches, bibliography reviews, and keyword searches, of which 117 references were included in the pathogen-specific reviews. Conclusions The strength of observational data describing enteric pathogens in MSM and possible sexual transmission of enteric pathogens varies by pathogen; however, a robust body of literature describes the sexual transmission of Campylobacter, Giardia lamblia, and Shigella (particularly antimicrobial-resistant strains) in sexual networks of MSM. Providers are encouraged to consider enteritis or proctocolitis in MSM as possibly having been sexually transmitted and encourage targeted STI testing. Risk/harm reduction and prevention messages should also be incorporated, though there is an acknowledged paucity of evidence with regards to effective strategies. Further research is needed to understand the transmission and prevention of enteric pathogens in MSM.

National guidelines for the care of human immunodeficiency virus (HIV)-infected persons recommend asymptomatic routine screening for sexually transmitted diseases (STDs). Our objective was to determine whether providers who care for HIV-infected men who have sex with men (MSM) followed these guidelines.We abstracted medical records to evaluate STD screening at 8 large HIV clinics in 6 US cities. We estimated the number of men who had at least one test for syphilis, chlamydia (urethral and/or rectal), or gonorrhea (urethral, rectal, and/or pharyngeal) in 2004, 2005, and 2006. Urethral testing included nucleic acid amplification tests of both urethral swabs and urine. We also calculated the positivity of syphilis, chlamydia, and gonorrhea among screened men.Medical records were abstracted for 1334 HIV-infected MSM who made 14,659 visits from 2004-2006. The annual screening rate for syphilis ranged from 66.0% to 75.8% during 2004-2006. Rectal chlamydia and rectal and pharyngeal gonorrhea annual screening rates ranged from 2.3% to 8.5% despite moderate to high positivity among specimens from asymptomatic patients (3.0%-9.8%) during this period. Annual urethral chlamydia and gonorrhea screening rates were higher than rates for nonurethral sites, but were suboptimal, and ranged from 13.8% to 18.3%.Most asymptomatic HIV-infected MSM were screened for syphilis, indicating good provider adherence to this screening guideline. Low screening rates for gonorrhea and chlamydia, especially at rectal and pharyngeal sites, suggest that substantial barriers exist for complying with these guidelines. The moderate to high prevalence of asymptomatic chlamydial and gonococcal infections underscores the importance of screening. A range of clinical quality improvement interventions are needed to increase screening, including increasing the awareness of nucleic acid amplification tests for nonurethral screening.

Musculoskeletal infections constitute an unusual clinical manifestation in patients with human immunodeficiency virus (HIV) infection. Available information about patients' characteristics and their clinical course has been obtained mainly from case reports and small retrospective studies. Our retrospective study is the largest in the literature providing detailed information about the clinical and laboratory characteristics of HIV-infected patients with different musculoskeletal infections. We identified 30 patients with various infections of the musculoskeletal system during a 5-year period among a cohort of 3,000-4,000 HIV-infected patients, and we describe them along with all cases of musculoskeletal infections in patients with HIV reported in the literature since 1985. Septic arthritis was the most commonly reported infection of the musculoskeletal system. It usually affects young men with a median CD4 count of 241. The exact contribution of a previous history of intravenous drug abuse in the pathogenesis of septic arthritis is unclear from the present and previous studies. Staphylococcus aureus was the most commonly isolated agent (31.3%). Numerous atypical pathogens were also identified as causes of septic arthritis. Approximately 90% of patients recovered with appropriate antibiotic treatment. Osteomyelitis was a more serious infection which also affected young individuals but with lower CD4 counts (median, 41). Half the cases were due to atypical mycobacteria. The mortality rate in the previously reported cases and in our series was high (20%). Pyomyositis is an increasingly recognized infection of the striated muscles in HIV-infected patients. It affects almost exclusively males with advanced HIV infection (median CD4 count, 24). Most cases are due to Staphylococcus aureus (67%). Drainage of the involved muscle(s) accompanied by proper antibiotic treatment resulted in resolution of the infection in the majority of patients (90%). Although the incidence of musculoskeletal infections in patients with HIV from this and previous studies appears to be low (0.3%-3.5%), these infections add a significant morbidity and mortality in the affected individuals. Better understanding of their pathogenesis and clinical course would aid the proper diagnosis and management of these infections.

A comprehensive medical evaluation to identify persistent and untreated tropical infections among members of the Sudanese group “Lost Boys of Sudan” living in Atlanta, GA, was initiated. Medical examinations and laboratory testing including blood cell counts, liver function tests, stool studies for parasites, hepatitis B serologies, and serologic testing for Schistosoma spp., Strongyloides, and filariae were performed. Preliminary results showed a high prevalence of untreated active schistosomiasis and strongyloidiasis infections in this group, 5 years after their resettlement in the United States. In addition, we found that many of them were infected with onchocerciasis and hepatitis B. We suggest that based on these preliminary results, pre-departure presumptive treatment and/or testing algorithms need to address some of these persistent tropical infections.