CROI 2016 Abstract eBook

Abstract Listing

Oral Abstracts

39 Three-Year Outcomes in PMTCT-Exposed Children Switched to EFV Once Suppressed on LPVr

Pamela Murnane 1 ; Renate Strehlau 2 ; Stephanie Shiau 3 ; Sarah Ramteke 4 ; Faeezah Patel 2 ; Elaine J. Abrams 5 ; Ashraf Coovadia 2 ; Louise Kuhn 4 ; for the NEVEREST III StudyTeam 1 Columbia Univ, Johannesburg, South Africa; 2 Univ of the Witwatersrand, Johannesburg, South Africa; 3 Columbia Univ Med Cntr, New York, NY, USA; 4 Columbia Univ, New York, NY, USA; 5 ICAP, Columbia Univ Mailman Sch of PH, New York, NY, USA Background: We have previously demonstrated the non-inferiority in virological control through 48 weeks of switching to efavirenz (EFV) vs. remaining on lopinavir/ritonavir (LPV/r) in PMTCT-exposed children initially suppressed on LPV/r. Here we describe the sustainability of outcomes over 3 years. Methods: From 2010-2013, 298 HIV-infected children exposed to PMTCT containing nevirapine who initiated LPV/r-based treatment <3 years of age and who had HIV RNA <50 copies/mL were recruited into a randomized clinical trial in Johannesburg, South Africa. Children were randomized to remain on LPV/r or to switch to EFV and were followed for 48 weeks. Primary outcomes were viral rebound (HIV RNA >50 copies/mL) and viral failure (HIV RNA >1000 copies/mL confirmed). After trial completion, participants were invited to enroll into an observational cohort study including 6-monthly follow-up visits. We examined differences in viral rebound, viral failure, CD4 percent and lipids across arms over 3 years of follow-up. All analyses were intent-to-treat. Results: Among 298 children enrolled in the original trial, 237 also enrolled in the observational study. Children were followed a median of 37 months (IQR 29.2-48.2) from randomization. Among those in follow-up at 3 years, 94% of those in the EFV arm remained on EFV and 87% in the LPV/r arm remained on LPV/r. Over 3 years of follow-up, the risk of viral rebound was lower in the EFV arm vs. the LPV/r arm (OR 0.64, p=0.005), as was the risk of viral failure (OR 0.50, p=0.05); the cumulative probability of rebound was lower in the EFV arm at 1, 2 and 3 years (Table). The risk of CD4%<35 was reduced in the EFV arm vs. the LPV/r arm (OR 0.56, p=0.007). Additionally the risk of elevated or abnormal lipids was lower among those randomized to EFV, including total cholesterol ≥5.2 mmol/L (OR 0.40, p=0.002), LDL ≥3.4 mmol/L (OR 0.45, p=0.002), and triglycerides >1.69 mmol/L (OR 0.42, p<0.0001). HDL did not significantly differ by arm. Conclusions: Three years after randomization, we found no evidence that children randomized to EFV had compromised virological outcomes relative to remaining on LPV/r. Children in the EFV arm had a lower risk of viral rebound, higher CD4 percentages, and improved lipid profiles compared to children randomized to LPV/r. Our results support the utility of this strategy, which has several advantages, including simplification of tuberculosis treatment, palatability, potential for once-daily dosing, lower cost and preservation of second line options.

Oral Abstracts

15

CROI 2016