Observational cohort study of rilpivirine (RPV) utilization in Europe

Abstract

Introduction Data on safety and effectiveness of RPV from the real-world setting as well as comparisons with other NNRTIs such as efavirenz (EFV) remain scarce. Methods Participants of EuroSIDA were included if they had started a RPV- or an EFV-containing regimen over November 2011-December 2017. Statistical testing was conducted using non-parametric Mann–Whitney U test and Chi-square test. A logistic regression model was used to compare participants’ characteristics by treatment group. Kaplan–Meier analysis was used to estimate the cumulative risk of virological failure (VF, two consecutive values > 50 copies/mL). Results 1,355 PLWH who started a RPV-based regimen (11% ART-naïve), as well as 333 initiating an EFV-containing regimen were included. Participants who started RPV differed from those starting EFV for demographics (age, geographical region) and immune-virological profiles (CD4 count, HIV RNA). The cumulative risk of VF for the RPV-based group was 4.5% (95% CI 3.3–5.7%) by 2 years from starting treatment (71 total VF events). Five out of 15 (33%) with resistance data available in the RPV group showed resistance-associated mutations vs. 3/13 (23%) among those in the EFV group. Discontinuations due to intolerance/toxicity were reported for 73 (15%) of RPV- vs. 45 (30%) of EFV-treated participants (p = 0.0001). The main difference was for toxicity of central nervous system (CNS, 3% vs. 22%, p < 0.001). Conclusion Our estimates of VF > 50 copies/mL and resistance in participants treated with RPV were similar to those reported by other studies. RPV safety profile was favourable with less frequent discontinuation due to toxicity than EFV (especially for CNS).

Common antiretroviral combinations are associated with somatic depressive symptoms in women with HIV

“…On the other hand, prescription bias is still possible due to factors unaccounted for in our model. Regarding RPV, TDF, FTC combination, our findings suggest that it has no detrimental association with depressive symptoms and rather a possible improvement which has been previously described [71,72].…”

Lipids and Transaminase in Antiretroviral-Treatment-Experienced People Living with HIV, Switching to a Doravirine-Based vs. a Rilpivirine-Based Regimen: Data from a Real-Life Setting

“…Since the RPV cohort opened in January 2013 and closed in September 2017, whereas the DOR cohort opened in February 2020 and is currently ongoing, the median observation time was different, being 16 months (interquartile range [8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] and [12][13][14][15][16][17][18][19][20], respectively, (p = 0.01). Thus, we limited the prospective analysis to the first year of study.…”

“…In a real-world setting comparing a RPV- to an EFV-containing regimen, discontinuations due to intolerance/toxicity were reported for 15% of RPV- vs. 30% of EFV-treated participants. The main difference was for toxicity of CNS (3% vs. 22%, p < 0.001) [ 22 ].…”

Lipids and transaminase elevations in ARV-experienced PLWH switching to a doravirine-based regimen from rilpivirine or other regimens

“…DOR and rilpivirine (RPV), another second-generation NNRTI approved in 2011, are generally considered safe drugs, especially regarding cardiovascular impact [3][4][5].…”