2483. Characteristics and Outcomes Over First 12 Months of a Two-Drug Regimen (Dolutegravir/Rilpivirine) for Treatment of HIV-1 in the United States

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 months with 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 January 1, 2018 to December 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 (December 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 Figures 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) (Figure 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 (Figure 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. [Image: see text] [Image: see text] [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures.