Session: 262. HIV: Antiretroviral Therapy, Saturday, 12:15-1:30 p.m.
Background : Robust pharmacoeconomic modeling is dependent on high quality inputs, preferably from randomized clinical trials (RCT), but not all needed head to head comparisons occur in RCTs. We compared virologic outcomes in an antiretroviral (ART) naïve population initiating a dolutegravir (DTG) or elvitegravir (EVG) based regimen using clinical trial-like criteria.
Methods : ART-naïve adults, initiating a DTG- or EVG- based regimen and meeting all study eligibility criteria (Fig. 1) were identified in the OPERA® Observational Database, a collaboration of HIV caregivers following 100,000+ people living with HIV (PLWH) through electronic medical records. PLWH were followed from the date of first prescription until DTG- or EVG- discontinuation, death, or study end (07/31/2018). The primary outcome was verified (2 consecutive viral load (VL) ≥ 200 copies/mL or 1 VL ≥ 200 copies + discontinuation) virologic failure (VF), defined as either failure to achieve suppression (< 50 copies/mL) prior to 36 weeks or failure to maintain suppression once achieved. Survival analyses were conducted with Kaplan Meier methods and multivariate Cox Proportional Hazards modeling.
Results : A total of 1688 (DTG) and 2537 (EVG) met all eligibility criteria. Median (IQR) length of follow-up in the DTG users was 21 months (14-30), in the EVG users was 20 (14-32) months. Figure 2 characterizes baseline demographic/ clinical characteristics. Figures 3 and 4 depict Kaplan Meier curves and Cox model results respectively. VF was experienced by 8.2% DTG and 10.9% EVG initiators at a rate (95% CI) per 1000 person-years of 40.2 (33.8, 47.8) and 51.3 (45.3, 58.1) respectively. Younger age (18-25), being African American, having a baseline CD4 count ≤ 200, or having a government-based payer (ADAP, Ryan White, Medicaid or Medicare) at baseline were associated with a significant (p < .05), increased hazard of VF. Initiating on DTG or initiating therapy with a lower baseline VL was associated with a significant, reduced hazard of VF. Compared to DTG, the adjusted hazard ratio for VF was 1.29 (95% CI: 1.02, 1.63) for EVG.
Conclusion : Among ART-naïve patients, DTG users were significantly less likely to experience virologic failure than EVG users after adjustment for important baseline covariates.
Michael Wohlfeiler– Chief Medical Officer, AIDS Healthcare Foundation, Miami Beach, FL
Kathy Schulman– Senior Director, Epividian, Inc., Durham, NC
Jennifer Fusco– President - Chief Science Officer, Epividian, Inc., Durham, NC
Yogesh Punekar– Sr. Director, ViiV Healthcare, Brentford, England, United Kingdom
Anthony Mills– Chief Medical Officer, Men’s Health Foundation, Los Angeles, CA
Julie Priest– Director, ViiV Healthcare, Durham, NC
Alan Oglesby– Sr. Director, ViiV Healthcare, Research Triangle Park, NC
Gregory Fusco– Chief Executive Officer and Chief Medical Officer, Epividian, Inc., Durham, NC