P-178 Evaluating tolerance and safety profiles of pre-exposure prophylaxis (PrEP) for HIV: insights from renal and hepatic function monitoring

• Published in: Sexually transmitted infections Vol. 100; no. Suppl 1; pp. A250 - A251
• Main Authors: Cuomo, G, Menozzi, M, Albertini, M, Todisco, V, Gozzi, L, Martini, E, Lusetti, D, Guaraldi, G, Mussini, C
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group Ltd 01.06.2024; BMJ Publishing Group LTD
• Subjects: Antiretroviral drugs; Creatinine; Disease prevention; Toxicity
• ISSN: 1368-4973; 1472-3263
• DOI: 10.1136/sextrans-ICAR-2024.241

IntroductionThe availability of HIV Pre-Exposure Prophylaxis (PrEP) is expanding in Italy. Tenofovir disoproxil/emtricitabine (TDF/FTC) exposure is associated with an increased incidence of adverse effects. Our study aim was to assess the safety and tolerability of PrEP, focusing on hepatic and renal function in the Modena cohort.MethodsRetrospective study including data from April 2018 to February 2024. We included all patients >18 years old referred to our PrEP service, who had a minimum follow-up of 30 days (equivalent to 2 visits) and had either completed at least one course of TDF/FTC either on demand or daily. Nephrotoxicity was defined as an increase of at least 50% in creatinine by 2 mg/dL and ALT elevation above 40 U/L. Users underwent quarterly monitoring of serum creatinine and ALT, in addition to routine PrEP screening. Univariate analyses were conducted using chi-square and t-student tests to compare variables, and a Kaplan-Meier curve was used to identify renal failure events.Results182 subjects started PrEP, 26 were excluded for not meeting inclusion criteria, leaving 156 subjects included. Predominantly male (98.7%) and of Italian origin (89.7%), the cohort primarily consisted of men who have sex with men (MSM). Risky sexual encounters were the main reason for initiating PrEP (80.1%). The on-demand regimen was favored by 62.8% of users, with adherence achieved in 94.9% of them. Median follow-up was 453 days. The discontinuation rate was 25%, mainly due to loss to follow-up (17.9%), with only one discontinuation attributed to side effects. Toxicity was reported in 23.1% of subjects, primarily gastrointestinal symptoms (13.5%), ALT elevation (5.8%), headache (2.6%), and one case (0.6%) of renal toxicity leading to PrEP discontinuation (table 1). Analysis of serum creatinine indicated a statistically significant increase between baseline and follow-up measurements (p<0.01), while ALT levels remained unchanged (table 2). Kaplan-Meier analysis revealed an increasing trend over time in cases with creatinine >1.4 mg/dL (figure 1). Multivariate analysis showed a significantly longer PrEP period (p=0.002) and a greater% increase in creatinine (p=0.041) among individuals experiencing side effects versus who did not, with no differences regarding regimen type, adherence, or comorbidities. Users with comorbidities were significantly older (p<0.001), had fewer therapeutic interruptions (p=0.016), and exhibited a greater ALT delta between follow-up measurements (p=0.047) than healthy people (tables 3–4).ConclusionsPrEP demonstrated good tolerability among our users, with minimal reported side effects and discontinuations. Nonetheless, the observed statistically significant increase in serum creatinine during therapy and significant changes in ALT levels among patients with comorbidities underscore the importance of continued clinical and laboratory monitoring of PrEP recipients.Abstract P-178 Table 1General characteristics of the study populationAbstract P-178 Table 2Median creatine and ALT at baseline and follow-up (24), and comparison by T-test of values in the two periods (2B)