2486. Clinical Outcomes of Patients Treated with Dolutegravir Functional Monotherapy or Dolutegravir plus an Active Non-cytosine Nucleoside Analog: A Retrospective Observational Cohort Study of Treatment-Experienced Patients

BACKGROUND: Dual dolutegravir (DTG)-containing regimens (DCRs) are currently approved for the treatment of antiretroviral (ARV) naïve and experienced patients with HIV-1 infection. DTG monotherapy has resulted in unacceptable rates of virologic failure and subsequent development of DTG resistance. Here, we evaluate the “real-world” efficacy and “barrier to resistance” of DCRs containing 0–1 active ARVs. METHODS: This is a retrospective observational study evaluating clinical outcomes of treatment-experienced patients on combination DCRs found to be on DTG functional monotherapy or DTG plus an active non-cytosine analog between 2013 and 2014. The primary endpoint was virologic suppression (HIV-1 RNA< 50 copies/mL) at week 48. Virologic failure (VF) was defined as confirmed HIV-1 RNA≥ 50 copies/mL 12 weeks after initiating DTG or any time after achieving HIV-1 RNA< 50 copies/mL. Adherence, adverse events (AEs) and laboratory parameters were analyzed throughout the study. RESULTS: Thirty-nine patients were included in the analysis, 19 (49%) were on DTG functional monotherapy and 20 (51%) were on DTG plus a non-cytosine nucleoside analog. The median age (range) was 53 (40–74) years, median baseline CD4+ count (range) was 564 (92–1217) cells/mm(3), 22 (56%) had baseline HIV-1 RNA< 50 copies/mL, and 24 (62%) had previously used INSTIs (Table 1). At Weeks 48 and 96, virologic suppression was observed in 78.3% and 86% of patients respectively (Figures 1 and 2). Among 7 VFs (2 on DTG functional monotherapy, 5 on DTG plus a non-cytosine nucleoside analog), there was no evidence of treatment-emergent resistance to DTG. There was a significant median increase in CD4+ count from baseline to Week 48 (+90 cells/mm(3), 95% confidence interval: [14.18, 165.9]). No significant changes in lipid parameters were observed. Treatment-related AEs occurred in 17/39 (44%) patients (all Grade 1–2) and 1 patient discontinued DCR treatment due to rash. CONCLUSION: In this “real-world” cohort of treatment-experienced patients, we observed that DTG functional monotherapy and DTG plus a non-cytosine nucleoside analog maintained long-term virologic control and was well tolerated. These data supports use of DTG as a partner for dual DCRs given its high efficacy in patients with underlying ARV resistance. [Image: see text] [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures.