Rilpivirine plus cobicistat-boosted darunavir as a two-drug switch regimen in HIV-infected, virologically suppressed subjects on steady standard three-drug therapy: a randomized, controlled, non-inferiority trial (PROBE 2).
J Antimicrob Chemother
; 75(5): 1332-1337, 2020 05 01.
Article
em En
| MEDLINE
| ID: mdl-32129855
ABSTRACT
BACKGROUND:
We explored the combination of rilpivirine plus cobicistat-boosted darunavir [a two-drug regimen (2DR)] when switching from standard triple combined ART.METHODS:
In this randomized, open-label, non-inferiority trial, participants had an HIV-RNA <50â copies/mL on a stable (>6â months) three-drug regimen. The primary endpoint was proportion with HIV-RNA <50â copies/mL at Week 24 (snapshot algorithm), with a -12% non-inferiority margin. ClinicalTrials.gov NCT04064632.RESULTS:
One hundred and sixty patients were allocated (11) to 2DR or to continue current ART (CAR). At Week 24, 72 (90.0%) of participants with 2DR and 75 (93.8%) with CAR maintained HIV-RNA <50â copies/mL [difference -3.75% (95% CI = -11.63 to 5.63)], confirming non-inferiority. Non-inferiority was confirmed considering an HIV-RNA >50â copies/mL (0% for 2DR; 3.7% for CAR; 95% CI = -0.4 to 7.9). Four patients reported adverse events not leading to treatment discontinuation (one patient in the 2DR group and three patients in the CAR group); eight subjects discontinued therapy in the 2DR group and three in the CAR group. With 2DR, lipid serum concentrations increased, but differences were statistically significant only for tenofovir disoproxil fumarate-containing CAR and in 2DR patients receiving a pre-switch regimen including tenofovir disoproxil fumarate. Median bone stiffness decreased in the CAR group from 86.1â g/cm2 (IQR = 74-98) to 83.2â g/cm2 (IQR = 74-97) and increased in the 2DR group from 84.9â g/cm2 (IQR = 74-103) to 85.5â g/cm2 (IQR = 74-101). The reduction within the CAR group was significant (P = 0.043).CONCLUSIONS:
Once-daily rilpivirine plus cobicistat-boosted darunavir is an effective 2DR that combines a high virological efficacy with a potential to avoid major NRTI toxicities.
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Preparações Farmacêuticas
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Infecções por HIV
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HIV-1
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Fármacos Anti-HIV
Tipo de estudo:
Clinical_trials
Limite:
Humans
Idioma:
En
Ano de publicação:
2020
Tipo de documento:
Article