Cabotegravir for HIV Prevention in Cisgender Men and Transgender Women.

BACKGROUND: Safe and effective long-acting injectable agents for preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection are needed to increase the options for preventing HIV infection. METHODS: We conducted a randomized, double-blind, double-dummy, noninferiority trial to compare long-acting injectable cabotegravir (CAB-LA, an integrase strand-transfer inhibitor [INSTI]) at a dose of 600 mg, given intramuscularly every 8 weeks, with daily oral tenofovir disoproxil fumarate-emtricitabine (TDF-FTC) for the prevention of HIV infection in at-risk cisgender men who have sex with men (MSM) and in at-risk transgender women who have sex with men. Participants were randomly assigned (1:1) to receive one of the two regimens and were followed for 153 weeks. HIV testing and safety evaluations were performed. The primary end point was incident HIV infection. RESULTS: The intention-to-treat population included 4566 participants who underwent randomization; 570 (12.5%) identified as transgender women, and the median age was 26 years (interquartile range, 22 to 32). The trial was stopped early for efficacy on review of the results of the first preplanned interim end-point analysis. Among 1698 participants from the United States, 845 (49.8%) identified as Black. Incident HIV infection occurred in 52 participants: 13 in the cabotegravir group (incidence, 0.41 per 100 person-years) and 39 in the TDF-FTC group (incidence, 1.22 per 100 person-years) (hazard ratio, 0.34; 95% confidence interval, 0.18 to 0.62). The effect was consistent across prespecified subgroups. Injection-site reactions were reported in 81.4% of the participants in the cabotegravir group and in 31.3% of those in the TDF-FTC group. In the participants in whom HIV infection was diagnosed after exposure to CAB-LA, INSTI resistance and delays in the detection of HIV infection were noted. No safety concerns were identified. CONCLUSIONS: CAB-LA was superior to daily oral TDF-FTC in preventing HIV infection among MSM and transgender women. Strategies are needed to prevent INSTI resistance in cases of CAB-LA PrEP failure. (Funded by the National Institute of Allergy and Infectious Diseases and others; HPTN 083 ClinicalTrials.gov number, NCT02720094.).

Epidemiology of Mpox Cases, and Tecovirimat and JYNNEOS Utilization, Alameda County, California, June-October 2022.

CONTEXT: The 2022 United States mpox outbreak disproportionately affected racial and ethnic minority gay, bisexual, and other men who have sex with men. PROGRAM: We utilized surveillance data and vaccination registries to determine whether populations most impacted by mpox in Alameda County received JYNNEOS vaccines and tecovirimat (TPOXX) during June 1-October 31, 2022. IMPLEMENTATION: Alameda County Public Health Department responded to the mpox epidemic through partnerships with local health care providers who serve communities disproportionately affected by mpox. EVALUATION: During June 1-October 31, 2022, a total of 242 mpox cases were identified in Alameda County. Mpox incidence rates per 100 000 were highest among Black/African American (35.7; 95% confidence interval [CI], 26.8-46.5) and Hispanic/Latinx (25.1; CI, 20.1-30.9) residents, compared to Asian (3.8; CI, 2.3-5.9) and White (10.5; CI, 7.7-13.9) residents. Most confirmed cases were identified as gay, lesbian, or same-gender-loving (134, 67.3%) and bisexual (31, 15.6%); 226 (93.8%) cases were male. Sixty-nine (28.5%) mpox patients received TPOXX. There were no statistically significant differences in demographic and clinical characteristics of mpox cases when compared by TPOXX receipt status. JYNNEOS vaccine was received by 8277 Alameda County residents. The largest proportion of vaccinees were White residents (40.2%). Administration rates per 100 000 men who have sex with men were lowest among Asian and Hispanic/Latinx individuals, at 8779 (CI, 8283-9296) and 14 953 (CI, 14 156-15 784), respectively. Black/African American and Hispanic/Latinx males had the lowest vaccination-to-case ratios at 16.7 and 14.8, respectively. DISCUSSION: Mpox disproportionately affected Black/African American and Hispanic/Latinx men who have sex with men in Alameda County. Strong partnerships with local health care providers ensured that persons with mpox received TPOXX treatment when indicated. However, higher JYNNEOS vaccine uptake in Black and Latinx communities needs improvement through ongoing and meaningful engagement with Black/African American and Hispanic/Latinx gay, bisexual, and transgender communities.

Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026).

This study describes the acceptability of a rectal microbicide gel formulation using dapivirine (DPV) among men and women from two countries (United States and Thailand) participating in the Microbicide Trials Network-026 trial. We evaluated participants' acceptability of a rectal DPV/placebo gel as part of a Phase I trial (N = 26; 18 male, 8 female). Participants reported favorable acceptability of the study gel, with most participants reporting that they liked the gel the same (n = 14; 53.8%) or more (n = 11; 42.4%) than when they started the trial. Over half of participants noted that they would prefer the gel over condoms (n = 13; 50%) or that they liked condoms and the gel equally (n = 8; 30.8%). Side effects across products included leakage (n = 8; 30.8%), diarrhea (n = 4; 15.4%), or soiling (n = 1; 3.8%). The high acceptability of a rectal gel underscores its promise as a short-acting biomedical prevention, warranting future research for HIV prevention.Trial Registration: NCT03239483.

RESUMEN: Este estudio describe la aceptabilidad de un microbicida rectal (RM) con dapivirina (DPV) formulado como un gel por hombres y mujeres de dos países (Estados Unidos y Tailandia) que participaron como parte del Microbicide Trials Network (MTN)-026. Evaluamos la aceptabilidad de un gel rectal de DPV y un placebo como parte de un estudio de Fase I (N = 26; 18 hombres, 8 mujeres). Los participants informaron una aceptabilidad favorable sobre el gel del estudio; la mayoría de los participantes informaron que les gustó el gel igual (n = 14; 53.8%) o más (n = 11; 42.4%) que cuando comenzaron el estudio. Más de la mitad de los participantes señalaron que preferirían el gel sobre los condones (n = 13; 50%) o que les gustaban los condones y el gel por igual (n = 8; 30,8%). Los efectos de los productos incluyeron fugas (n = 8; 30,8%), diarrea (n = 4; 15,4%) o ensuciamiento (n = 1; 3,8%). La alta aceptabilidad de un gel rectal enfatiza su promesa para la prevención biomédica de acción corta y justifica futuras investigaciones para la prevención del VIH.

HIV and syphilis prevalence among transgender women and men who have sex with men, Silom Community Clinic, Bangkok, Thailand, 2017-2019.

We assessed HIV and syphilis infection among MSM and TGW attending Silom Community Clinic from 2017 to 2019. Walk-in and referral clients completed a registration application including a question on gender identity. We compared the prevalence of HIV, syphilis, and HIV and syphilis coinfection among TGW and MSM. In a total of 1050 clients, 276 (26.3%) were TGW and 774 (74.7%) were MSM. Among TGW clients, HIV prevalence was 29.8%, syphilis prevalence was 38.4%, and coinfection prevalence was 18.5%. Comparing prevalence among TGW to MSM, the adjusted prevalence ratio (aPR) for HIV was 1.8 (95% CI:1.4-2.3), for syphilis was 1.2 (95% CI:1.0-1.4), and for HIV and syphilis coinfection was 2.1 (95% CI:1.4-2.9). The prevalence of syphilis was higher than HIV among TGW, with a PR of 1.3 (95% CI:1.1-1.6), and among MSM, with a PR of 1.4 (95% CI:1.2-1.7). TGW age 15-21 years had an HIV prevalence of 16.9% and syphilis prevalence of 30.8%. After adjusting for age, referral, and sexual behaviors, TGW remain significantly associated with HIV and syphilis prevalence. There is a substantial burden of HIV and HIV/syphilis co-infection among TGW. HIV/STI prevention are needed for TGW, including linkage to HIV care.

Young Men Who Have Sex with Men at High Risk for HIV, Bangkok MSM Cohort Study, Thailand 2006-2014.

High HIV incidence has been reported in young men who have sex with men (YMSM) in North America and Western Europe, but there are limited data from Southeast Asia suggesting MSM may be the driver of the HIV epidemic in this region. We described HIV incidence and risk factors among 494 YMSM enrolled in a cohort study in Bangkok, Thailand. The HIV incidence was 7.4 per 100 person-years. In multivariable analysis, reporting use of an erectile dysfunction drug in combination with club drugs, having receptive or both insertive and receptive anal intercourse with men, having hepatitis A infection, having rectal Chlamydia trachomatis, having hepatitis B infection prior to HIV seroconversion, and reporting not always using condoms with male steady partners were significantly associated with HIV incidence in YMSM. Reduction in new HIV infections in YMSM are critical to reach targets set by Thailand and the region.

Reduction in Human Papillomavirus Vaccine Type Prevalence Among Young Women Screened for Cervical Cancer in an Integrated US Healthcare Delivery System in 2007 and 2012-2013.

BACKGROUND: In the United States, human papillomavirus (HPV) vaccine is recommended for 11- or 12-year-olds, and for young adults not previously vaccinated. Early vaccine impact can be measured by reductions in vaccine-type (VT) HPV prevalence. METHODS: Consecutive residual cervical specimens were retained from women aged 20-29 years at Kaiser Permanente Northwest in 2007, 2012, and 2013. HPV genotypes were determined using L1 consensus polymerase chain reaction with type-specific hybridization to detect 37 types, including VT HPV (HPV type 6, 11, 16, and 18). We compared HPV prevalence in 2007 and 2012-2013, and we evaluated predictors of VT HPV and any-HPV prevalence in 2012-2013. RESULTS: In 2012-2013, 31.9% of 4181 women had initiated HPV vaccination. VT HPV prevalence decreased from 10.6% in 2007 to 6.2% in 2012-2013 (P < .001). In 2012-2013, VT HPV prevalence was significantly lower among those who initiated vaccination <19 years (adjusted prevalence ratio, 0.1; 95% confidence interval, .1-.3) than among those who were not vaccinated, and higher among those who had chlamydia, human immunodeficiency virus, or pregnancy testing in the past year than among those who did not (adjusted prevalence ratio, 1.4; 95% confidence interval, 1.1-1.8). CONCLUSIONS: Reduction in VT HPV was found in young women in an integrated healthcare delivery system within 6 years of vaccine introduction, indicating early HPV vaccine impact.

Human Papillomavirus and Genital Warts: A Review of the Evidence for the 2015 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines.

To provide updates for the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines on human papillomavirus (HPV) and anogenital warts (AGWs), a review of the literature was conducted in key topic areas: (1) epidemiology and burden of disease; (2) transmission and natural history; (3) diagnosis and management of AGWs; (4) occupational exposure of healthcare workers; (5) anal cancer screening among men who have sex with men (MSM); and (6) HPV vaccine recommendations. Most sexually active persons will have detectable HPV at least once in their lifetime; 14 million persons are infected annually, and 79 million persons have prevalent infection. HPV is transmitted frequently between partners; more frequent transmission has been reported from females to males than from males to females. A new formulation of imiquimod (3.75% cream) is recommended for AGW treatment. Appropriate infection control, including performing laser or electrocautery in ventilated rooms using standard precautions, is recommended to prevent possible transmission to healthcare workers who treat anogenital warts, oral warts, and anogenital intraepithelial neoplasias (eg, cervical intraepithelial neoplasia). Data are insufficient to recommend routine anal cancer screening with anal cytology in persons living with human immunodeficiency virus (HIV)/AIDS or HIV-negative MSM. An annual digital anorectal examination may be useful for early detection of anal cancer in these populations. HPV vaccine is recommended routinely for 11- or 12-year-olds, as well as for young men through age 21 years and young women through age 26 years who have not previously been vaccinated. HPV vaccine is also recommended for MSM, people living with HIV/AIDS, and immunocompromised persons through age 26 years.

Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP).

This report summarizes the epidemiology of human papillomavirus (HPV) and associated diseases, describes the licensed HPV vaccines, provides updated data from clinical trials and postlicensure safety studies, and compiles recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of HPV vaccines. Persistent infection with oncogenic HPV types can cause cervical cancer in women as well as other anogenital and oropharyngeal cancers in women and men. HPV also causes genital warts. Two HPV vaccines are licensed in the United States. Both are composed of type-specific HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein using recombinant DNA technology produces noninfectious virus-like particles (VLPs). Quadrivalent HPV vaccine (HPV4) contains four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18. Bivalent HPV vaccine (HPV2) contains two HPV type-specific VLPs prepared from the L1 proteins of HPV 16 and 18. Both vaccines are administered in a 3-dose series. ACIP recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. Vaccination also is recommended for females aged 13 through 26 years and for males aged 13 through 21 years who were not vaccinated previously. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not previously vaccinated. As a compendium of all current recommendations for use of HPV vaccines, information in this report is intended for use by clinicians, vaccination providers, public health officials, and immunization program personnel as a resource. ACIP recommendations are reviewed periodically and are revised as indicated when new information and data become available.

Prevalence of cervical and oral human papillomavirus infections among US women.

Data from the National Health and Nutrition Examination Survey, 2009-2010, indicated that the prevalence of human papillomavirus (HPV) infection among women was 42.7% in the cervix and 3.8% in the oral cavity. The prevalence of oral HPV infection was 5-fold higher among women with than among those without cervical HPV infection (7.0% vs 1.4%; prevalence ratio, 4.9 [95% confidence interval, 2.7-8.7]). Among the 3% of women with HPV detected at both sites, complete type concordance was detected in 6.6%, and partial agreement was detected in 37.7%. These data suggest that HPV infections at these 2 sites are not independent, although type-specific concordance is low.

Prevaccine era human papillomavirus types 6, 11, 16 and 18 seropositivity in the U.S.A., National Health and Nutrition Examination Surveys, 2003-2006.

BACKGROUND: A vaccine is available to prevent human papillomavirus (HPV) 6, 11, 16 and 18; in the prevaccine era, seropositivity to vaccine types is a measure of natural exposure. METHODS: We describe HPV seropositivity in the USA among 14-59-year-olds using the 2003-2006 National Health and Nutrition Examination Surveys. RESULTS: Seropositivity to HPV 6, 11, 16 and 18 was 17.5%, 6.8%, 15.1% and 5.9%, respectively, among women, and 7.0%, 2.4%, 5.2% and 1.5%, respectively, among men. Overall in both sexes, seropositivity was 22.5% for any vaccine type (31.8% in women and 12.9% in men), but substantially lower for three or more types (1.7% overall, 2.8% in women and 0.6% in men). CONCLUSIONS: Almost a quarter of the participants were seropositive to any HPV vaccine type but few were seropositive to at least three vaccine HPV types in the prevaccine era. Further study is needed to assess if seropositivity would be useful as a biological marker of vaccination.