First‐line antiretroviral therapy with efavirenz plus tenofovir disiproxil fumarate/emtricitabine or rilpivirine plus tenofovir disiproxil fumarate/emtricitabine: a durability comparison

Taramasso, Lucia; Biagio, Antonio Di; Maggiolo, Franco; Tavelli, Alessandro; Caputo, Sergio Lo; Bonora, Stefano; Zaccarelli, Mauro; Caramello, Pietro; Costantini, Andrea; Viscoli, Claudio; Monforte, Antonella d’Arminio; Cozzi‐Lepri, Alessandro; Andreoni, Massimo; Angarano, Gioacchino; Antinori, Andrea; Castelli, Francesco; Cauda, Roberto; Perri, Giovanni Di; Galli, Massimo; Iardino, R.; Ippolito, Giuseppe; Lazzarin, Adriano; Perno, Carlo Federico; Schloesser, F. von; Viale, Pierluigi; Castagna, Antonella; Ceccherini‐Silberstein, Francesca; Girardi, Erika; Mussini, Cristina; Puoti, Massimo; Ammassari, Adriana; Balotta, Claudia; Bandera, Alessandra; Bonfanti, Paolo; Borderi, Marco; Calcagno, Andrea; Calza, Leonardo; Capobianchi, M.R.; Cingolani, Antonella; Cinque, Paola; Luca, Andrea De; Gianotti, Nicola; Gori, Andrea; Guaraldi, Giovanni; Lapadula, Giuseppe; Lichtner, Miriam; Madeddu, Giordano; Marchetti, Giulia; Marcotullio, Simone; Monno, Laura; Nozza, Silvia; Quiros-Roldan, Eugenia; Rossotti, Roberto; Rusconi, Stefano; Santoro, Maria Mercedes; Saracino, Annalisa; Fanti, Iuri; Galli, Laura; Lorenzini, Patrizia; Rodanò, A.; Shanyinde, Milensu; Carletti, Fabrizio; Carrara, Stefania; Di, Antonino; Graziano, Silvia; Petrone, Fabrizio; Prota, Gennaro; Quartu, Serena; Truffa, Silvia; Giacometti, Andrea; Valeriani, C.; Santoro, Carmen Rita; Suardi, C.; Donati, Valentina; Verucchi, Gabriella; Minardi, C; Quirino, Tiziana; Abeli, C.; Manconi, Paolo Emilio; Piano, P.; Cacopardo, Bruno; Celesia, Benedetto Maurizio; Vecchiet, Jacopo; Falasca, Katia; Sighinolfi, Laura; Segala, Daniela; Mazzotta, Francesco; Vichi, Francesca; Cassola, Giovanni; Alessandrini, A.; Bobbio, Nicoletta; Mazzarello, Giovanni; Mastroianni, Claudio Maria; Belvisi, Valeria; Caramma, Ilaria; Chiodera, Alessandro; Castelli, Antonio; Rizzardini, Giuliano; Ridolfo, Annalisa; Piolini, R.; Salpietro, Stefania; Carenzi, Laura; Moioli, Maria Cristina; Tincati, Camilla; Puzzolante, Cinzia; Abrescia, Nicola G. A.; Chirianni, Antonio; Borgia, Guglielmo; Martino, Filomena Di; Maddaloni, L.; Gentile, I.; Orlando, Raffaele; Baldelli, Franco; Francisci, Daniela; Parruti, Giustino; Ursini, Tamara; Magnani, Giacomo; Ursitti, M. A.; Vullo, Vincenzo; Cristaudo, Alfonso; Baldin, Gianmaria; Cicalini, Stefania; Gallo, L.; Nicastri, Emanuele; Acinapura, R.; Capozzi, M.; Libertone, Raffaella; Savinelli, Stefano; Latini, Alessandra; Cecchetto, M.; Viviani, Filippo; Mura, María Stella; Rossetti, Barbara; Orofino, Giancarlo; Sciandra, Mauro; Bassetti, Matteo; Londero, Angela; Pellizzer, G.; Manfrin, Vinicio

doi:10.1111/hiv.12628

Cited by 15 publications

(10 citation statements)

References 29 publications

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“…In an observational study from the ICONA cohort, the rate of discontinuation was higher (10.1%; 95% CI [7.6-12.7%] at 2years). 14 The main reasons for discontinuation in this ICONA study were similar to those in our study (treatment failure, 25.0% versus 23.4% and adverse events, 47.1% versus 43.9%). While HBV or HCV coinfection were associated with a lower VS rate at week 48 in the pooled data of the Echo and Thrive trials, we did not find such a trend in our study, even if the proportions of HBV or HCV coinfected PLHIV were similar.…”

Section: Discussionsupporting

confidence: 84%

Use of rilpivirine in HIV-1-infected individuals in routine clinical practice from 2012 to 2017 in France

Potard

Gallien

Canestri

et al. 2020

Journal of Antimicrobial Chemotherapy

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Objectives We assessed virological outcomes of rilpivirine use in France from 2012 to 2017, in three groups of people living with HIV (PLHIV): (i) antiretroviral (ARV)-naive PLHIV; (ii) ARV-experienced PLHIV switching to rilpivirine while failing therapy; and (iii) ARV-experienced PLHIV switching to rilpivirine while virologically controlled. Methods Virological success (VS) was defined as a plasma HIV-1 viral load (VL) <50 copies/mL and virological failure (VF) as two consecutive VL >50 copies/mL or one VL >50 copies/mL followed by a treatment switch prior to the next VL measurement. The cumulative incidence of VS was assessed considering rilpivirine discontinuation, loss to follow-up and death as competing risks, while estimates of cumulative incidence of VF accounted for loss to follow-up and death. Results Among the 2166 ARV-naive PLHIV initiating rilpivirine, the 4 year cumulative incidence of VS was 91.0% and was associated with baseline VL. Among the 2125 ARV-experienced PLHIV switching to rilpivirine while failing therapy, the 4 year cumulative incidence of VS was 82.5% and was associated with lower VL, higher CD4 and less than three prior ARVs. Among the 11 828 ARV-experienced PLHIV switching to rilpivirine while virologically controlled, the 4 year cumulative incidence of VF was 9.6%. The risk of VF was lower among MSM, for PLHIV with CD4 ≥ 500 cell/mm3, without a prior AIDS event, or with a longer VL suppression at baseline. Conclusions Rilpivirine-containing regimens yielded high rates of viral suppression in most participants, while it was ineffective when used outside the marketing authorization in naive participants.

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Section: Discussionsupporting

confidence: 84%

Use of rilpivirine in HIV-1-infected individuals in routine clinical practice from 2012 to 2017 in France

Potard

Gallien

Canestri

et al. 2020

Journal of Antimicrobial Chemotherapy

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“…Rilpivirine (RPV) has been shown to have low metabolic impact as well, and could be a suitable companion for TAF due to its neutral profile on lipids [5–7]. Moreover, RPV also satisfies the needs of modern ART, being a well-tolerated and durable regimen, available in single tablet regimen co-formulated with TDF and emtricitabine (RPV/FTC/TAF) or with TAF and emtricitabine (RPV/FTC/TAF) [8–10]. A randomized, controlled, double-blind, Phase 3 trial evaluated the switching strategy from RPV/FTC/TDF to RPV/FTC/TAF in virologically suppressed patients.…”

Section: Introductionmentioning

confidence: 99%

Lipid profile changings after switching from rilpivirine/tenofovir disoproxil fumarate/emtricitabine to rilpivirine/tenofovir alafenamide/emtricitabine: Different effects in patients with or without baseline hypercholesterolemia

et al. 2019

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Tenofovir alafenamide (TAF) has similar efficacy compared to tenofovir disoproxil fumarate (TDF), but a less favorable effect on lipids. Aim of this retrospective multicentre study was to evaluate the impact on lipids of switching from rilpivirine (RPV)/ emtricitabine (FTC)/TDF to RPV/FTC/TAF in a cohort of HIV-1 infected patients. Total cholesterol (TC), high density lipoproteins (HDL) and low density lipoproteins (LDL) were compared at the moment of the switch and at the first following evaluation, by using paired t-test. Overall, 573 patients were considered, 99% with HIV-RNA <50 copies/ml, with mean age of 49.7 (±0.4) years and median 13.4 (6.9–22.5) years of HIV infection. In the study population with available data (431/573, 75%), mean TC changed from 173 ±1.7 to 188 ±1.8 mg/dl; mean HDL from 46 ±0.7 to 51± 0.7 mg/dl; mean LDL from 111 ±1.5 to 120 ±1.8 mg/dl (p<0.0001 for all). Neither LDL/HDL nor TC/HDL ratio changed significantly, with LDL/HDL from 2.6 ±0.5 to 2.5 ±0.5 (p = 0.12) and TC/HDL from 4.0 ±0.6 to 3.9 ±0.6 (p = 0.11). In patients with baseline diagnosis of hypercholesterolemia (TC>200 mg/dl, N = 87), there was no significant change in TC (224 ±2.2 to 228 ±3.4 mg/dl, p = 0.286) or LDL (150±2.5 to 151±3.2 mg/dl, p = 0.751), while HDL increased from 51 ±1.6 to 55 ±1.7 mg/dl (p<0.0001) and both LDL/HDL and TC/HDL ratio decreased significantly, from 3.2±0.1 to 3.0 ±0.1 (p = 0.025) and from 4.7±0.1 to 4.4 ±0.1 (p = 0.004). In this real life study, a slight increase in lipids was found after switching from RPV/FTC/TDF to RPV/FTC/TAF, but these results were not confirmed in people with hypercholesterolemia, in which lipids did not change and LDL/HDL and TC/HDL ratio decreased.

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“…[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.…”

Section: Discussionmentioning

confidence: 86%

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

et al. 2019

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Background: Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods: Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results: A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13-20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions: DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

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First‐line antiretroviral therapy with efavirenz plus tenofovir disiproxil fumarate/emtricitabine or rilpivirine plus tenofovir disiproxil fumarate/emtricitabine: a durability comparison

Abstract: In our nonrandomized comparison, RPV was better tolerated, less toxic and showed longer durability than EFV, without a significant difference in rates of discontinuation because of failures.

Cited by 15 publications

References 29 publications

Use of rilpivirine in HIV-1-infected individuals in routine clinical practice from 2012 to 2017 in France

Use of rilpivirine in HIV-1-infected individuals in routine clinical practice from 2012 to 2017 in France

Lipid profile changings after switching from rilpivirine/tenofovir disoproxil fumarate/emtricitabine to rilpivirine/tenofovir alafenamide/emtricitabine: Different effects in patients with or without baseline hypercholesterolemia

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

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