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Safety and efficacy of dolutegravir plus rilpivirine (DTG/RPV) in treatment-experienced HIV-infected patients: preliminary results at 24 weeks of the DORIVIR study
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Good HIV Control After 24 Weeks of Dolutegravir/Rilpivirine Maintenance
HIV Drug Therapy, Glasgow 2016
Mark Mascolini
Almost everyone switching to dolutegravir/rilpivirine (DTG/RPV) from another regimen or starting the integrase inhibitor and nonnucleoside after an antiretroviral break had a viral load below 50 copies after 24 weeks in an 85-person analysis [1]. The three people with detectable HIV RNA after 24 weeks had loads ranging from 75 to 532 copies.
A two-pill once-daily regimen of DTG plus RPV (50/25 mg) is in phase 3 trials as maintenance therapy [2,3]. To get a short-term look at outcomes with this novel combination, researchers in southern Spain conducted this 7-hospital open-label analysis of people switching to DTG/RPV from any antiretroviral combination or resuming therapy after a break from February 2015 through February 2016. The primary endpoint was the proportion of participants with a viral load below 50 copies after 24 weeks in a missing-equals-failure analysis.
The study included 104 people, 82 of them (79%) virologically suppressed and switching from another regimen and 22 with a detectable viral load (14 restarting treatment). Seventy-three of these people (70%) were men, including 34 men who have sex with men (32%). Median age stood at 51 years, time since HIV diagnosis 238.5 months, and time on the prior regimen 26.4 months. The largest proportion of participants, 42%, switched to DTG/RPV because of toxicity or intolerance, while 28% changed for convenience and 17% for drug interactions. The prior regimen included a protease inhibitor in 57%, an integrase inhibitor in 27%, and a nonnucleoside in 16%. Clinicians genotyped some but not all patients for resistant virus before starting DTG/RPV.
No one stopped DTG/RPV because of adverse events. Of the 85 people who had reached 24 weeks of follow-up after starting DTG/RPV, 82 (96.5%) had a viral load below 50 copies. The remaining 3 people had viral loads of 75, 316, and 532 copies and were not considered virologic failures. Through 24 weeks, median CD4 count rose from 536 to 591 (P = 0.008).
Total, HDL, and LDL cholesterol remained stable through 24 weeks, while median triglycerides fell from 149 to 128 mg/dL (P = 0.005). Glomerular filtration rate fell significantly from 88 to 80 mL/min (P = 0.004).
The investigators concluded that DTG/RPV was effective over 24 weeks in people with a long antiretroviral history and usually switching from a more complex regimen.
References
1. Rosario Palacios R, Mayorga M, Gonzalez-Domenech CM, et al. Safety and efficacy of dolutegravir plus rilpivirine (DTG/RPV) in treatment-experienced HIV-infected patients: preliminary results at 24 weeks of the DORIVIR study. HIV Drug Therapy, Glasgow 2016. October 23-26, 2016. Abstract P054.
2. ClinicalTrials.gov. Regimen switch to dolutegravir + rilpivirine from current antiretroviral regimen in human immunodeficiency virus type 1 infected and virologically suppressed adults (SWORD-1). ClinicalTrials.gov identifier NCT02429791.
https://clinicaltrials.gov/ct2/show/NCT02429791
3. ClinicalTrials.gov. Regimen switch to dolutegravir + rilpivirine from current antiretroviral regimen in human immunodeficiency virus type 1 infected and virologically suppressed adults (SWORD-2). ClinicalTrials.gov identifier NCT02422797.
https://clinicaltrials.gov/ct2/show/NCT02422797
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