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Side effects are a common concern of current and potential HIV pre-exposure prophylaxis (PrEP) users, potentially leading to missed doses. We examined the relationship between reported side effects and adherence in the Ontario PrEP Cohort Study (ON-PrEP). In total, 600 predominantly gay (87.3%), White (65.8%), and male (95.0%) participants completed questionnaires assessing the presence and severity of five side effect categories (nausea, diarrhea, headache, abdominal pain, and "other") as well as their adherence to daily PrEP (any missed doses in the previous 4 days). In total, 175 participants (29%) ever reported experiencing side effects: most commonly diarrhea (7.5% of study visits), and most were of mild severity. Lower incomes (p = 0.01), identifying as bisexual (p = 0.04), and baseline concern about side effects (p < 0.001) were associated with ever reporting side effects. The odds of reporting any side effects decreased by a factor of 0.44 (95% confidence interval 0.25–0.80) with each additional year of PrEP use, however 1 in 10 participants still reported side effects after 1 year of use. The odds of reporting optimal adherence were 0.48 (0.28–0.83) times lower for participants reporting any side effects, 0.67 (0.51–0.89) times lower per additional side effect category reported, and 0.78 (0.65–0.97) times lower per incremental increase in side effect severity ratings. We found some evidence of interaction between side effect measures and duration of PrEP use, suggesting that these relationships were stronger for participants taking PrEP for longer. Clinicians should make efforts to ascertain patients' experience of side effects and consider risk counseling and alternative PrEP regimens to promote adherence. [ABSTRACT FROM AUTHOR]

COVID-19 breakthrough infection (BTI) can occur despite vaccination. Using a multi-centre, prospective, observational Canadian cohort of people with HIV (PWH) receiving ≥2 COVID-19 vaccines, we compared the SARS-CoV-2 spike (S) and receptor-binding domain (RBD)-specific IgG levels 3 and 6 months post second dose, as well as 1 month post third dose, in PWH with and without BTI. BTI was defined as positivity based on self-report measures (data up to last study visit) or IgG data (up to 1 month post dose 3). The self-report measures were based on their symptoms and either a positive PCR or rapid antigen test. The analysis was restricted to persons without previous COVID-19 infection. Persons without BTI remained COVID-19-naïve until ≥3 months following the third dose. Of 289 participants, 92 developed BTI (31.5 infections per 100 person-years). The median days between last vaccination and BTI was 128 (IQR 67, 176), with the most cases occurring between the third and fourth dose (n = 59), corresponding to the Omicron wave. In analyses adjusted for age, sex, race, multimorbidity, hypertension, chronic kidney disease, diabetes and obesity, a lower IgG S/RBD (log10 BAU/mL) at 1 month post dose 3 was significantly associated with BTI, suggesting that a lower IgG level at this time point may predict BTI in this cohort of PWH. [ABSTRACT FROM AUTHOR]

Background With many global jurisdictions, Toronto, Canada, experienced an mpox outbreak in spring/summer 2022. Cases declined following implementation of a large vaccination campaign. A surge in early 2023 led to speculation that asymptomatic and/or undetected local transmission was occurring in the city. Methods Mpox cases and positive laboratory results are reported to Toronto Public Health. Epidemic curves and descriptive risk factor summaries for the 2022 and 2023 outbreaks were generated. First- and second-dose vaccination was monitored. Mpox virus wastewater surveillance and whole genome sequencing were conducted to generate hypotheses about the source of the 2023 resurgence. Results An overall 515 cases were reported in spring/summer 2022 and 17 in the 2022–2023 resurgence. Wastewater data correlated with the timing of cases. Whole genome sequencing showed that 2022–2023 cases were distinct from 2022 cases and closer to sequences from another country, suggesting a new importation as a source. At the start of the resurgence, approximately 16% of first-dose vaccine recipients had completed their second dose. Conclusions This investigation demonstrates the importance of ongoing surveillance and preparedness for mpox outbreaks. Undetected local transmission was not a likely source of the 2022–2023 resurgence. Ongoing preexposure vaccine promotion remains important to mitigate disease burden. [ABSTRACT FROM AUTHOR]

Background and Objectives: Until recently, gay, bisexual and other men who have sex with men (MSM) were deferred from donating blood for 3–12 months since the last male‐to‐male sexual contact. This MSM deferral has been discontinued by several high‐income countries (HIC) that now perform gender‐neutral donor selection. Materials and Methods: An international symposium (held on 20‐04‐2023) gathered experts from seven HICs to (1) discuss how this paradigm shift might affect the mitigation strategies for transfusion‐transmitted infections and (2) address the challenges related to gender‐neutral donor selection. Results: Most countries employed a similar approach for implementing a gender‐neutral donor selection policy: key stakeholders were consulted; the transition was bridged by time‐limited deferrals; donor compliance was monitored; and questions or remarks on anal sex and the number and/or type of sexual partners were often added. Many countries have now adopted a gender‐neutral approach in which questions on pre‐ and post‐exposure prophylaxis for human immunodeficiency virus (HIV) have been added (or retained, when already in place). Other countries used mitigation strategies, such as plasma quarantine or pathogen reduction technologies for plasma and/or platelets. Conclusion: The experience with gender‐neutral donor selection has been largely positive among the countries covered herein and seems to be acceptable to stakeholders, donors and staff. The post‐implementation surveillance data collected so far appear reassuring with regards to safety, although longer observation periods are necessary. The putative risks associated with HIV antiretrovirals should be further investigated. [ABSTRACT FROM AUTHOR]

Background Longitudinal data on the detectability of monkeypox virus (MPXV) genetic material in different specimen types are scarce. Methods We describe MPXV-specific polymerase chain reaction (PCR) results from adults with confirmed mpox infection from Toronto, Canada, including a cohort undergoing weekly collection of specimens from multiple anatomic sites until 1 week after skin lesions had fully healed. We quantified the time from symptom onset to resolution of detectable viral DNA (computed tomography [Ct] ≥ 35) by modeling exponential decay in Ct value as a function of illness day for each site, censoring at the time of tecovirimat initiation. Results Among 64 men who have sex with men, the median (interquartile range [IQR]) age was 39 (32.75–45.25) years, and 49% had HIV. Twenty received tecovirimat. Viral DNA was detectable (Ct < 35) at baseline in 74% of genital/buttock/perianal skin swabs, 56% of other skin swabs, 44% of rectal swabs, 37% of throat swabs, 27% of urine, 26% of nasopharyngeal swabs, and 8% of semen samples. The median time to resolution of detectable DNA (IQR) was longest for genital/buttock/perianal skin and other skin swabs at 30.0 (23.0–47.9) and 22.4 (16.6–29.4) days, respectively, and shortest for nasopharyngeal swabs and semen at 0 (0–12.1) and 0 (0–0) days, respectively. We did not observe an effect of tecovirimat on the rate of decay in viral DNA detectability in any specimen type (all P >.05). Conclusions MPXV DNA detectability varies by specimen type and persists for over 3–4 weeks in skin specimens. The rate of decay did not differ by tecovirimat use in this nonrandomized study. [ABSTRACT FROM AUTHOR]

The COVID‐19 pandemic led to the widespread adoption of virtual care—the use of communication technologies to receive health care at home. We explored the differential impacts of the rapid transition to virtual care during the COVID‐19 pandemic on health‐care access and delivery for gay, bisexual and queer men (GBQM), a population that disproportionately experiences sexual and mental health disparities in Canada. Adopting a sociomaterial theoretical perspective, we analysed 93 semi‐structured interviews with GBQM (n = 93) in Montreal, Toronto and Vancouver, Canada, conducted between November 2020 and February 2021 (n = 42) and June‐October 2021 (n = 51). We focused on explicating how the dynamic relations of humans and non‐humans in everyday virtual care practices have opened or foreclosed different care capacities for GBQM. Our analysis revealed that the rapid expansion and implementation of virtual care during the COVID‐19 pandemic enacted disruptions and challenges while providing benefits to health‐care access among some GBQM. Further, virtual care required participants to change their sociomaterial practices to receive health care effectively, including learning new ways of communicating with providers. Our sociomaterial analysis provides a framework that helps identify what works and what needs to be improved when delivering virtual care to meet the health needs of GBQM and other diverse populations. [ABSTRACT FROM AUTHOR]

Objectives: Bictegravir/tenofovir alafenamide/emtricitabine (BIC/TAF/FTC) is a complete regimen for the treatment of HIV with a high barrier to resistance and few reported cases of treatment failure. We present three cases of treatment‐emergent resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in patients with suboptimal treatment adherence and assess whether the resistance‐associated mutations were present before BIC/TAF/FTC initiation or emerged during therapy. Methods: We used genotypic drug resistance testing by Sanger sequencing to identify emergent resistance mutations in plasma viral load specimens collected after combination antiretroviral therapy initiation in all participants. Additionally, we performed ultra‐deep sequencing by Illumina MiSeq on the earliest available plasma HIV‐1 viral load specimen and on any available specimens closest in time to the initiation of BIC/TAF/FTC therapy to identify low‐abundance resistance mutations present in the viral quasispecies. Results: All three participants developed NRTI resistance after prolonged exposure and incomplete adherence to BIC/TAF/FTC. The T69N, K70E, M184I, and/or T215I mutations identified in clinical samples at the time of virological failure were not present on deep sequencing of either baseline samples or samples collected before BIC/TAF/FTC initiation. Conclusions: Despite a generally high genetic barrier to resistance, NRTI resistance‐associated mutations may emerge during therapy with BIC/TAF/FTC in the setting of suboptimal adherence. [ABSTRACT FROM AUTHOR]

Youth (aged 15 to 29 years) account for one quarter of new HIV cases in Canada. Of those, men-who-have-sex-with-men make up one third to one half of new cases in that age range. Moreover, Indigenous youth are over-represented in the proportion of new cases. The use of emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) significantly reduces the risk of HIV acquisition in adults. Its use was expanded to include youth over 35 kg by the U.S. Food and Drug Administration in 2018. However, PrEP uptake remains low among adolescents. Prescriber-identified barriers include lack of experience, concerns about safety, unfamiliarity with follow-up guidelines, and costs. This article provides an overview of PrEP for youth in Canada, and its associated safety and side effect profiles. Hypothetical case vignettes highlight some of the many demographics of youth who could benefit from PrEP. We present a novel flow diagram that explains the baseline workup, prescribing guidelines, and follow-up recommendations in the Canadian context. Additional counselling points highlight some of the key discussions that should be elicited when prescribing PrEP. [ABSTRACT FROM AUTHOR]

Background Real-world evidence of human papillomavirus (HPV) vaccine effectiveness (VE) against longitudinal outcomes is lacking among gay, bisexual, and other men who have sex with men (GBM). We compared 12-month incidence and persistence of anal HPV infection between vaccinated and unvaccinated GBM. Methods We recruited GBM aged 16–30 years in Montreal, Toronto, and Vancouver, Canada, from 2017 to 2019. Participants were followed over a median of 12 months (interquartile range, 12–13 months). Participants self-reported HPV vaccination and self-collected anal specimens for HPV DNA testing. We calculated prevalence ratios (PR) for 12-month cumulative incidence and persistence with ≥1 quadrivalent vaccine type (HPV 6/11/16/18) between vaccinated (≥1 dose at baseline) and unvaccinated participants using a propensity score-weighted, modified Poisson regression. Results Among 248 participants, 109 (44.0%) were vaccinated at baseline, of whom 62.6% received 3 doses. PRs for HPV 6/11/16/18 were 0.56 (95% confidence interval [CI],.24–1.31) for cumulative incidence and 0.53 (95% CI,.25–1.14) for persistence. PRs were 0.23 (95% CI,.05–1.03) and 0.08 (95% CI,.01–.59) for incidence and persistence, respectively, among participants who received their first dose at age ≤23 years and 0.15 (95% CI,.03–.68) and 0.12 (95% CI,.03–.54) among participants who were sexually active for ≤5 years before vaccination. Conclusions Findings support national recommendations for HPV vaccination at younger ages or soon after sexual debut. [ABSTRACT FROM AUTHOR]

Background. Little is known about the effects of disclosure of HIV-serodiscordant relationships on clinical outcomes. We aimed to evaluate the effect of relationship disclosure on HIV viral suppression, and hypothesized that disclosure by HIV-positive and HIV-negative partners would be associated with viral suppression in the HIV-positive partner. Methods. We conducted a Canadian national online and telephone-administered survey of HIV-positive and HIV-negative partners in serodiscordant relationships. The primary outcome was self-reported viral suppression. Multivariable analyses were undertaken using Firth logistic regression. Results. We recruited 540 participants in current serodiscordant relationships (n = 228 HIV-negative; n = 312 HIV-positive). Similar proportions of HIV-positive and HIV-negative partners disclosed their relationship to healthcare professionals (82% v. 76%, p = 0.13). Among HIV-positive partners, disclosure of the relationship to healthcare professionals increased the odds of viral suppression (aOR = 4.7; CI: 2.13, 10.51) after adjusting for age, education, and relationship turmoil due to HIV. Increasing age (aOR = 1.28; 95% CI = 1.07, 1.55) and education (aOR = 2.43; 95% CI = 1.15, 5.26) were also associated with viral suppression. Among HIV-negative partners, relationship disclosure was not associated with viral suppression and HIV-negative heterosexual men were less likely to report that their HIV-positive partners were virally suppressed (aOR = 0.24; CI: 0.09, 0.61). Conclusions. Disclosure of HIV-serodiscordant status by HIV-positive participants to healthcare professionals was associated with increased odds of viral suppression. Similar effects were not evident among HIV-negative participants. Future work should explore factors that empower relationship disclosure and incorporate them into supportive services for HIV-serodiscordant relationships. [ABSTRACT FROM AUTHOR]

Background. Our objective was to understand what gay, bisexual, and queer men (GBQM) who had experience using pre-exposure prophylaxis (PrEP) thought about the 'Undetectable equals Untransmittable' (U=U) message and how it informed their sexual decision-making over time. Methods. We conducted annual longitudinal qualitative interviews (2020-22) with 17 current or former PrEP users as part of a mixed-methods implementation science study examining barriers and facilitators to PrEP awareness, access, and adherence. Over 3 years, 47 interviews were conducted with GBQM in Ontario, Canada. Interviews were transcribed verbatim and coded in NVivo following reflexive thematic analysis. Results. Participants' sexual health decision-making was informed by their confidence in biomedical HIV prevention and the person taking medication (i.e. themselves using PrEP versus a real/imagined person living with HIV (PLHIV)). Longitudinal narratives of U=U clustered around four overarching themes: (1) U=U confidence (i.e. increasing trust in U=U irrespective of their PrEP use); (2) PrEP confidence (i.e. accounts of self-reliance and PrEP as sufficient HIV protection); (3) combination confidence (i.e. trusting U=U and PrEP as a package); and (4) partner confidence (i.e. potential 'distrust' of U=U due to uncertainties about partners' medication adherence). Overall, men described increased sex with PLHIV over time, including some participants who, during earlier interviews, said they would 'never be comfortable' with serodifferent sexual partners. Conclusions. GBQM's use of PrEP shaped how they thought about U=U and sex with PLHIV. Although many GBQM embraced treatment as prevention/U=U as significant to their sexual lives, longitudinal analysis revealed its varied and uneven adoption across participants and time. [ABSTRACT FROM AUTHOR]

The article discusses the progress made in addressing HIV globally, particularly in terms of treatment and prevention options such as pre-exposure prophylaxis (PrEP). While there has been a significant reduction in new HIV acquisitions and increased access to treatment and prevention options, progress for key populations (KPs) such as gay and other men who have sex with men, sex workers, transgender people, and people who inject drugs, remains uneven. Discriminatory and punitive legal and policy environments hinder the access and uptake of HIV-related services for KPs, leading to negative health consequences. The article emphasizes the need for legal and policy reform, increased funding for such efforts, and collaboration between healthcare providers and advocates to ensure access to services for all KPs. [Extracted from the article]