High Propensity to Switch to Long-acting Injectable HIV PrEP with Cabotegravir in a Cohort of Oral PrEP Experienced Men who Have Sex with Men in Italy.

Aim was to investigate the propensity to switch to long-acting injectable HIV pre-exposure prophylaxis (PrEP) with cabotegravir among oral PrEP-experienced men who have sex with men. Out of 377 PrEP users, 325 (86.2%) were interested (would like = 210) or considering (would consider = 115) switch to long-acting PrEP. At multivariable analysis, the odds ratio of interest in long-acting PrEP in non-adherent vs. adherent individuals to oral PrEP was 5.03 (95%CI = 1.73-14.61,p = 0.003) and of consideration 1.63 (95%CI = 0.51-5.23,p = 0.410). We observed very high propensity to switch to long-acting PrEP, particularly among non-adherent users. Rapid availability of long-acting PrEP might address unmet needs of PrEP users in Italy.

Viral Hepatitis and Human Papillomavirus Vaccination During HIV Pre-Exposure Prophylaxis: Factors Associated With Missed Vaccination.

BACKGROUND: We evaluated factors associated with lack of triple vaccination (hepatitis A virus [HAV], hepatitis B virus [HBV], and human papillomavirus [HPV]) among men who have sex with men using pre-exposure prophylaxis (PrEP). SETTING: PrEP users at the San Raffaele Scientific Institute, Italy, with ≥1 follow-up visit (May 2017-2022). METHODS: Participants were considered protected if (1) before PrEP access: positive serology (IgG-HAV+, hepatitis B surface antigen >10 mUI/mL) or vaccination history was recorded and (2) after starting PrEP: ≥1 dose of each vaccination was administered. Individuals were considered fully protected if they received the following before/during PrEP access: HAV vaccination/infection, HBV vaccination/infection, and HPV vaccination. χ 2 and Kruskal-Wallis tests were used to compare characteristics of those fully, partially, and not protected. Factors associated with the lack of triple vaccination were assessed by using multivariable logistic regression and classification tree analysis. RESULTS: Overall, 473 men who have sex with men were considered: 146 (31%) were fully protected, 231 (48%) partially, and 96 (20%) were not. Daily-based PrEP users (fully: 93, 63.7%; partially: 107, 46.3%; and not protected: 40, 41.7%; P = 0.001) and those with a sexually transmitted infection at the first visit (43, 29.5%; 55, 23.8%; 15, 15.6%; P = 0.048) were more frequently fully protected. At multivariable analysis, the odds of lack of triple vaccination was lower among daily-based users (adjusted odds ratio = 0.47, 95% confidence interval = 0.31-0.70, P < 0.001). Classification tree analysis showed that among daily-based users, with sexually transmitted infection prior and at the first PrEP visit, there was a lower chance of lack of triple vaccination ( P = 44%). CONCLUSIONS: Strategies targeting PrEP users at risk of missing HAV, HBV, and HPV vaccinations need to be implemented, focusing mostly on event-based users.

Bictegravir/Emtricitabine/Tenofovir Alafenamide Treatment: Efficacy and Tolerability in Clinical Practice.

Objective: Analysis of bictegravir/emtricitabine/tenofovir alafenamide (BFTAF) efficacy and safety in virologically suppressed people living with HIV (PLWH) in clinical practice. Patients and methods: The retrospective cohort study, which included adult treatment-experienced and virologically suppressed PLWH, switched to BFTAF from June 2019 to June 2021. Efficacy and safety were evaluated as virological failure (VF=2 consecutive HIV-RNA>50 copies/mL or a single HIV-RNA>400 copies/mL) and treatment failure (TF=VF or discontinuation for any reason) until data freezing (August 2022). Results: Of the 1040 PLWH included, 67.8% switched from elvitegravir/cobicistat/FTAF. VF occurred in 4.2% (n=44), with incidence rate of 1.63 per 1000 person-months of follow-up (PMFU) and probability at 24-30 months of 3.8%-4.0%, respectively. Out of the 44 VF, in 75% virological re-suppression was achieved while maintaining BFTAF. Discontinuation occurred in 15% after a median time of 13.5 months of follow-up, with an incidence rate of 5.67 per 1000 PMFU, and a probability at 24-30 months of 11.9%-15.3%, respectively. Main discontinuation reasons were simplification (51.3%) and toxicity (21.8%, involving CNS in half of cases). TF occurred in 18.6% with an incidence rate of 7.01 per 1000 PMFU after a median time of 13.6 observation months; probability at 24-30 months was 14.8%-18.4%, respectively. Conclusion: BFTAF has proven effective and well tolerated in clinical practice.

Mpox Outbreak 2022: A Comparative Analysis of the Characteristics of Individuals Receiving MVA-BN Vaccination and People Diagnosed with Mpox Infection in Milan, Italy.

Mpox caused a worldwide outbreak in 2022, disproportionately affecting MSM reporting high-risk sexual behaviors. The aim of this study was to compare the characteristics of people receiving MVA-BN vaccination with those of individuals diagnosed with mpox to guide future vaccination policies. This was a retrospective study on people with mpox infection or vaccination at San Raffaele Scientific Institute, Milan, Italy, from May to November 2022. Characteristics were compared using Mann-Whitney or chi-square/Fisher's exact tests; multivariable logistic regression and classification tree analysis were applied. Overall, 473 vaccinated individuals and 135 with mpox were included; 472/473 and 134/135 were MSM. People with mpox were more frequently living with HIV (48.9% vs. 22.4%, p < 0.001), had ≥1 previous STI (75.6% vs. 35.7%, p < 0.001), were chemsex users (37.8% vs. 6.34%, p < 0.001), were with a higher number of partners (23.0% vs. 1.69%, p < 0.001), and had engaged in group sex (55.6% vs. 24.1%, p < 0.001). At multivariable analysis, PLWH (aOR = 2.86, 95%CI = 1.59-5.19, p < 0.001), chemsex users (aOR = 2.96, 95%CI = 1.52-5.79, p = 0.001), those with previous syphilis (aOR = 4.11, 95%CI = 2.22-7.72, p < 0.001), and those with >10 partners (aOR = 11.56, 95%CI = 6.60-21.09, p < 0.001) had a higher risk of infection. This study underscores the importance of prioritizing MSM with prior STIs and multiple partners as well as chemsex users in vaccination policies to curb mpox spread. A destigmatized assessment of sexual history is vital for comprehensive sexual health strategies.

Viral blips and virologic failures following mpox vaccination with MVA-BN among people with HIV.

OBJECTIVES: The study aim was to evaluate whether mpox vaccination with modified vaccinia Ankara-Bavarian Nordic (MVA-BN) may be associated with viral blips or confirmed virologic failures (CVF) in people with HIV (PWH) receiving antiretroviral therapy and the associated factors. DESIGN: PWH who received MVA-BN, with HIV-RNA less than 50 copies/ml, and CD4 + lymphocytes at least 200 cells/µl in the 6 months prior to vaccination and at least 1 HIV-RNA determination within 3 months from vaccination. METHODS: The primary outcome was occurrence of viral blips (1 HIV-RNA ≥50 copies/ml) and CVF (1 HIV-RNA ≥1000 copies/ml or ≥2 consecutive HIV-RNA ≥50 copies/ml) following MVA-BN. Changes in CD4 + and CD4 + /CD8 + were secondary outcomes. Residual viremia was defined as detectable HIV-RNA less than 50 copies/ml. PWH already vaccinated against smallpox received single-dose MVA-BN. Mann--Whitney rank-sum test or chi-square/Fisher's test applied. RESULTS: Overall, 187 PWH were included: 147 received two doses of MVA-BN, 40 single-dose. Six viral blips [incidence rate = 1.59/100-person months of follow-up (PMFU), 95% confidence interval (95% CI) = 0.58-3.47], and three CVFs [incidence rate = 0.80/100-PMFU (95% CI = 0.16-2.33)] were observed. Two CVFs occurred at second dose with presence of detectable HIV-RNA following first one, with high compliance to antiretroviral therapy (ART). PWH with viral blips or CVFs had, prior to first vaccination, more frequently residual viremia [77% ( n  = 7) versus 35% ( n  = 62), P  = 0.01]. No differences in ART ( P  = 0.42) and number of MBA-BN doses ( P  = 0.40) was found. In two cases of CVFs, ART was changed; all VBs resolved within 1 month. CONCLUSION: Although rare, viral blips and CVFs following MVA-BN vaccination among PWH receiving ART were identified. Close monitoring of HIV-RNA during mpox vaccination should be encouraged.