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).

The Journal of Antimicrobial Chemotherapy
Franco MaggioloA Castagna

Abstract

We explored the combination of rilpivirine plus cobicistat-boosted darunavir [a two-drug regimen (2DR)] when switching from standard triple combined ART. In this randomized, open-label, non-inferiority trial, participants had an HIV-RNA <50 copies/mL on a stable (>6 months) three-drug regimen. The primary endpoint was proportion with HIV-RNA <50 copies/mL at Week 24 (snapshot algorithm), with a -12% non-inferiority margin. ClinicalTrials.gov: NCT04064632. One hundred and sixty patients were allocated (1:1) 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 <50 copies/mL [difference -3.75% (95% CI = -11.63 to 5.63)], confirming non-inferiority. Non-inferiority was confirmed considering an HIV-RNA >50 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 ...Continue Reading

Associated Clinical Trials

References

Dec 21, 2004·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Eugènia NegredoBonaventura Clotet
Apr 25, 2015·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Kathleen MulliganUNKNOWN Preexposure Prophylaxis Initiative Study Team
Feb 18, 2016·Drugs·Sean G KellyBabafemi O Taiwo
Feb 26, 2016·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Franco MaggioloAnnapaola Callegaro
Nov 16, 2016·HIV/AIDS : Research and Palliative Care·Jordi Navarro, Adrian Curran
Jul 26, 2017·Journal of Clinical Densitometry : the Official Journal of the International Society for Clinical Densitometry·Didier Hans, Sanford Baim

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Citations

Feb 10, 2021·Expert Opinion on Drug Safety·Julen CadiñanosJose R Arribas
Dec 17, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Kwok-Fong ChanSamuel Ken-En Gan

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