Session: 262. HIV: Antiretroviral Therapy, Saturday, 12:15-1:30 p.m.
Background : In 2017, the first complete antiretroviral regimen (ART) containing only two drugs, dolutegravir/rilpivirine (DTG/RPV), was approved for treatment of HIV-1 in virologically suppressed (< 50 copies/mL) patients on a stable ART regimen for ≥ 6 monthswith no history of treatment failure/resistance to DTG or RPV. Our objective was to characterize early utilization/outcomes of DTG/RPV in a real-world population.
Methods : HIV-1+ individuals initiating DTG/RPV from 1/1/2018 - 12/31/2018 were identified in the OPERA Database. Outcomes were evaluated among the virologically suppressed subgroup who initiated in the first 6 months. Discontinuation (d/c) was defined as cessation of DTG/RPV. Virologic failure (VF) was defined as either 2 consecutive HIV viral loads (VL) ≥ 200 copies/mL OR 1 VL ≥ 200 copies/mL + d/c. Population was observed from DTG/RPV start (index) until the first of: a) d/c, b) death or c) study end (12/31/2018). Demographic and clinical characteristics were described at index. Kaplan-Meier methods were used to describe d/c and VF.
Results : A total of 880 patients were prescribed DTG/RPV in the first 12 months; demographic and clinical characteristics are described in Figs 1 and 2. Most (76%) DTG/RPV users were virologically suppressed at initiation (n=671). Among the 197 (22%) ART experienced, viremic initiators, a third had a baseline VL ≥ 50 but < 200. Few patients were ART naïve (n=12, 1%). Index VL was unavailable for 21 (5%) initiators. Comorbidity was prevalent: 59% had ≥1 endocrine disorders; 42% hypertension, and 33% mental disorders. For the virologically suppressed at initiation, with ≥ 6 months of follow up (n=340); median (IQR) days on DTG/RPV was 248 (204-299); 88% remained on DTG/RPV at study end. Among the 42 (12.4%) discontinued patients, 41% were virologically stable (<200 copies/mL) at d/c. Median (IQR) days to d/c was 58 (29-141) (Fig 3). Most patients (n=288, 85%) had ≥ 1 VL during follow-up; 79% (n=270) had ≥1 VL during the first 24 weeks. Among these, VF occurred in 1.5% patients. Median (IQR) time to VF was 5.1 (2.0-9.2) months (Fig 4).
Conclusion : While DTG/RPV initiators were primarily ART-experienced, virologically suppressed individuals older than 50 years of age challenged by significant comorbid conditions, the frequency of d/c or VF in the first 12 months was low.
Gerald Pierone– Research Officer, Whole Family Health Center, Vero Beach, FL
Kathy Schulman– Senior Director, Epividian, Inc., Durham, NC
Jennifer Fusco– President - Chief Science Officer, Epividian, Inc., Durham, NC
Vani Vannappagari– Global Head, Epidemiology and Real World Evidence, ViiV Healthcare, Research Triangle Park, NC
Michael Aboud– Vice President & Head, International Medical Affairs, ViiV Healthcare, Brentford , Middlesex, England, United Kingdom
Leigh Ragone– Strategy & Governance Director, ViiV Healthcare, Research Triangle Park, NC
Gregory Fusco– Chief Executive Officer and Chief Medical Officer, Epividian, Inc., Durham, NC