Durability, safety, and efficacy of rilpivirine in clinical practice: results from the SCOLTA Project

Abstract

Rilpivirine is associated with a good efficacy and safety profile. However, data from real-life settings are scarce.MethodsWe investigated the durability, safety and efficacy of Rilpivirine-based antiretroviral therapy in a prospective, observational, multicenter study.ResultsWe enrolled 499 HIV-infected patients, 360 (72.1%) males, mean age 43.4 ± 10.5 years, mean CD4 600 ± 327 cell/μL, mean HIV-RNA 3.80 ± 1.15 log10 cp/mL. After a median follow up of 16 months, 81 (16.2%) interruptions were reported, 36 (7.2%) of which for adverse events (16 of grade ≥3), most commonly neurological and gastrointestinal. We observed virological failures in only 8 (1.6%) patients. Naive patients showed a significant reduction in eGFR at week 24, 48 and 72 and in total cholesterol (TC)/HDL ratio at week 48 (p=0.007). In patients switching from PI we found a significant decrease at week 24 and 48 in TC and triglycerides at week 24, 48 and 72. eGFR showed a significant decrease at week 48 and 72. TC/HDL ratio showed a statistically significant decrease at week 24 (p=0.0008) and 72 (p=0.04). A significant increase at week 24 and 48 in AST and ALT values was observed. Patients switching from TDF/FTC/EFV showed a reduction in HDL, total cholesterol and triglycerides at week 24 and 48 and in eGFR at all follow up times. TC/HDL ratio showed a significant decrease at week 48 (p=0.01). CDC stage C and antiretroviral-experience (especially Protease Inhibitors) were associated with RPV discontinuation.ConclusionIn conclusion, our data confirm Rilpivirine efficacy, safety and tolerability with improvement in lipid profile. Although hepatic and renal events rarely caused discontinuation, liver and kidney parameters should be monitored.

Efficacy and improvement of lipid profile after switching to rilpivirine in resource limited setting: real life clinical practice

“…There were two participants who discontinued RPV due to hepatitis (Grade 2–3). This finding is consistent with other studies [19, 21].…”

“…These results are consistent with other studies [14, 19, 20]. We observed a lower rate of RPV treatment discontinuation due to AE in our study compared to a previous study [21] (1.6% vs 7.2%).…”

Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA)

“…[29] On the contrary, PI triple therapy might be more generally prescribed to anyone, but demonstrated lower durability [30, 31], mainly for simplification or tolerability issues. Indeed, PIs have now many competitors in the modern ART scenario, including integrase inhibitors and rilpivirine, characterized by good tolerability and high durability [32–35]. In fact, despite DRV/c can be used in both naïve and experienced patients, our results showed as, in real life, it was mainly used in subjects switching from antiretroviral treatments already containing PI.…”

Usefulness of therapeutic drug monitoring of rilpivirine and its relationship with virologic response and resistance in a cohort of naive and pretreated HIV‐infected patients

“…These results were higher than in other published observational studies reporting discontinuation rates of 13-16% in TEP but with shorter follow-up of 12-16 months. 17,18 In contrast, Sculier et al reported 25% of discontinuation after a median time of 18.4 months. 22 Finally, our result was lower than the 34% showed by Bernaud et al, where the median time of follow-up was similar (36 months).…”

“…16 However, studies combining PK and efficacy of RPV are lacking in real-life contexts. [17][18][19][20][21][22] Hence, the present study assessed the antiviral activity of the RPV/FTC/TDF regimen and described the association of RPV exposure with virologic response and resistance in a cohort of NP and treatment-experienced patients (TEP) over 3 years of follow-up. What is known about this subject…”