Mauro Zaccarelli

Background: Anogenital warts (AGWs) represent the most common clinical manifestation of human papillomavirus (HPV) infection. The analysis of AGW time trends helps to investigate possible changes over time and monitor the impact of HPV vaccines on HPV-associated morbidity. Methods: AGWs diagnosed from 1991 to 2022 at a centre belonging to the Italian STI Surveillance Network were analysed in terms of their numbers and the socio-behavioural characteristics of the patients and then compared over the course of three decades. The time trends, overall and by transmission category, were investigated by joinpoint analysis. Results: In total, 9781 AGWs were diagnosed [61.9% in men who have sex with women (MSW)]. Individuals aged 25–34 years (36.9%), those with one recent partner (52.0%), and those with no previous STIs (87.8%) accounted for the majority of diagnoses. The HIV prevalence among individuals tested for HIV was 136/3098 (4.4%, 95% CI: 3.7–5.2). AGW diagnoses showed a mild decrease from 1991 to 2004, followed by a significant increase up to 2013 (the highest peak over the entire study period) and a significant decline thereafter, until the most recent years. During 2011–2022, diagnoses in women who have sex with men (WSM) decreased for those aged up to 24 years—the age class that could potentially have included women vaccinated against HPV. Conclusions: AGWs have declined in recent years. The decrease in the proportion of diagnoses in young WSM may reflect the female immunisation campaign in Italy. Nonetheless, there is still a need to promote vaccine uptake to reduce the AGW burden.

Efavirenz (EFV) administration is still controversial for its high rates of interruption mainly related to central nervous system side effects (CNS-SE). Aim of the study was to define if single tablet regimen (STR) as compared to bis-in-die (BID) or once-daily (OD) with ≥2 pills-a-day EFV formulations reduced the risk of interruption.

Background: Drug-related toxicity has been one of the main causes of antiretroviral treatment discontinuation. However, its determinants are not fully understood. Aim of this study was to investigate predictors of first-line antiretroviral therapy discontinuation due to adverse events and their evolution in recent years.Methods: Patients starting first-line antiretroviral therapy were retrospectively selected. Primary end-point was the time to discontinuation of therapy due to adverse events, estimating incidence, fitting Kaplan-Meier and multivariable Cox regression models upon clinical/demographic/chemical baseline patients’ markers.Results: 1,096 patients were included: 302 discontinuations for adverse events were observed over 1,861 person years of follow-up between 1988 and 2010, corresponding to an incidence (95% CI) of 0.16 (0.14-0.18). By Kaplan-Meier estimation, the probabilities (95% CI) of being free from an adverse event at 90 days, 180 days, one year, two years, and five years were 0.88 (0.86-0.90), 0.85 (0.83-0.87), 0.79 (0.76-0.81), 0.70 (0.67-0.74), 0.55 (0.50-0.61), respectively. The most represented adverse events were gastrointestinal symptoms (28.5%), hematological (13.2%) or metabolic (lipid and glucose metabolism, lipodystrophy) (11.3%) toxicities and hypersensitivity reactions (9.3%). Factors associated with an increased hazard of adverse events were: older age, CDC stage C, female gender, homo/bisexual risk group (vs. heterosexual), HBsAg-positivity. Among drugs, zidovudine, stavudine, zalcitabine, didanosine, full-dose ritonavir, indinavir but also efavirenz (actually recommended for first-line regimens) were associated to an increased hazard of toxicity. Moreover, patients infected by HIV genotype F1 showed a trend for a higher risk of adverse events.Conclusions: After starting antiretroviral therapy, the probability of remaining free from adverse events seems to decrease over time. Among drugs associated with increased toxicity, only one is currently recommended for first-line regimens but with improved drug formulation. Older age, CDC stage, MSM risk factor and gender are also associated with an increased hazard of toxicity and should be considered when designing a first-line regimen.