icon-folder.gif   Conference Reports for NATAP  
  HIV Glasgow
23-26 October 2016
Glasgow, UK
Back grey_arrow_rt.gif
Safety and efficacy of dolutegravir plus rilpivirine (DTG/RPV) in treatment-experienced HIV-infected patients: preliminary results at 24 weeks of the DORiViR study
  Switch to Dolutegravir plus Rilpivirine dual therapy in cART-Experienced Subjects: an italian cohort..... http://www.natap.org/2016/HIV/062416_05.htm Dolutegravir/Rilpivirine as Simpler Maintenance After Heavy Pretreatment.....http://www.natap.org/2016/IAC/IAC_06.htm
ViiV Healthcare begins phase iii programme with dolutegravir/rilpivirine combination for HIV maintenance therapy......https://www.viivhealthcare.com/media/press-releases/2015/may/viiv-healthcare-begins-phase-iii-programme-with-dolutegravirrilpivirine-combination-for-HIV-maintenance-therapy.aspx

Reported by Jules Levin
HIV Glasgow 2016 Oct 23-26
Rosario Palacios1; Marisa Mayorga2; Carmen-Maria Gonzalez-Domenech1; Carmen Hidalgo-Tenorio3; Carmen Galvez4; Leopoldo Munoz-Medina3; Javier de la Torre5; Ana Lozano6; Manuel Castano2; Mohamed Omar7 and Jesu s Santos1 1UGC Enfermedades infecciosas y Microbiologia, Hospital Virgen de la Victoria, Malaga, Spain. 2UGC Enfermedades infecciosas y Microbiologia, Hospital Carlos Haya, Malaga, Spain. 3Servicio de Enfermedades infecciosas, Complejo Hospitalario Universitario Granada, Granada, Spain. 4UGC Enfermedades infecciosas, Hospital Torrecardenas, Malaga, Spain. 5UGC Enfermedades infecciosas, Hospital Costa del Sol, Malaga Spain. 6UGC Enfermedades infecciosas, Hospital de Poniente, Almeria, Spain. 7UGC Enfermedades infecciosas, Hospital de Jaen, Jaen, Spain


Program Abstract
DTG/RPV is a two-pill nucleoside reverse transcriptase inhibitor (NRTi) and protease inhibitor (Pi)-sparing regimen with very good tolerance. it is currently in phase 3 clinical trials being developed as two-drug ''maintenance therapy''. The aim of this study is to analyze the efficacy and safety of this regimen in HIV-infected patients who switched from any other ART combination.
Methods: Open-label, multicentre, non-controlled study in seven hospitals from Andalusia, southern Spain. Patients who switched from any regimen to DTG/RPV from February 2015 to February 2016 were included. Epidemiological, clinical and antiretroviral data in addition to immediate reasons for switching were collected. Lipids, liver and renal tests were measured at baseline and at 24 weeks. The primary endpoint was the proportion of patients with plasma HIV RNA <50 copies/mL at 24 weeks (missingfailure), and secondary endpoints included adverse events and rate of discontinuation related with adverse events of dual therapy after switching and metabolic changes at 24 weeks.
Results: Hundred and five patients started DTG/RPV during the study period: 82 (78.1%) virologically suppressed, 22 (20.9%) nonvirologically suppressed (eight failures and 14 restart of ART) and one naive, who was not included for analysis. There were 70.5% men, mean age was 51.9 years, mean time of HIV infection 214.7 (iQR 140.4288.9) months, and mean time on the prior ART was 37.0 (iQR 7.868.2) months. The most frequent reasons for switching were toxicity or intolerance (41.9%), convenience (27.6%) and drugs interactions (17.1%). Prior regimens were based on Pi (56.9%), integrase inhibitors (26.5%) or non-NRTi (16.7%). At this time 85 patients have completed 24 weeks and all were still taking the same regimen, 82 (96.5%) of them with undetectable viral load; the three cases with detectable HIV RNA (532, 316 and 75 copies/mL, respectively) were not considered virological failures. Mean CD4 cells count increased (622 vs. 552 cells/mL; p=0.008), and a mean decrease in fasting triglycerides (-34.6 mg/dL; p=0.005) and glomerular filtration (-5.2 mL/min; p=0.004) were observed, with no changes detected in total cholesterol, HDL-c, LDL-c, creatinine and GPT. No patient stopped DTG/RPV due to adverse events.
Conclusions: DTG/RPV is effective and safe in a cohort of patients with long time of HIV infection and prior ART. Most patients changed from more complex regimens. Toxicity, intolerance, convenience and interactions were the main reasons for changing. At 24 weeks lipid profile improved with a decrease in triglycerides.