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Jane E. Mallewa1, Alexander J. Szubert2, Jay Berkley3, Sanele Nkomani4, Abraham Siika5, Peter Mugyenyi5, Andrew Prendergast6, Sarah Walker2, Diana Gibb2

1Malawi–Liverpool–Wellcome Trust Clinical Rsr Prog, Blantyre, Malawi,2Univ Coll London, London, UK,3KEMRI Wellcome Trust Rsr Prog, Kilifi, Kenya,4Univ of Zimbabwe Clinical Rsr Cntr, Harare, Zimbabwe,5Moi Univ, Eldoret, Kenya,6Queen Mary Univ of London, London, UK


Early mortality after antiretroviral therapy (ART) initiation is high among HIV-infected adults and children with severe immunosuppression in sub-Saharan Africa. Baseline malnutrition is common and increases mortality, but nutritional supplementation is generally only provided at ART initiation to those with severe malnutrition. Whether universal provision for those with advanced disease would improve nutritional status and reduce early mortality is unknown.

The REALITY 2x2x2 factorial open-label randomized trial (ISRCTN43622374) enrolled ART-naïve HIV-infected adults and children ≥5 years with CD4<100 cells/mm3 from Kenya, Malawi, Uganda and Zimbabwe and ended in March 2016. This randomization compared initiating ART with/without 12 weeks of Ready-to-Use Supplementary Food (RUSF), providing 1000kcal/day with multi-vitamins/minerals. Those with severe malnutrition received Ready-to-Use Therapeutic Food (RUTF) regardless of randomization. Two other randomizations investigated 12-week raltegravir intensification or enhanced infection prophylaxis. The primary endpoint was 24-week mortality.

1805 eligible adults (n=1733; 96.0%) and older children/adolescents (n=72; 4.0%) were enrolled, median age 36 years; 53.2% male; 53.7% WHO stage 3/4, and median baseline CD4 37 cells/mm3 (IQR 16-63). For those ≥13 years, median baseline weight was 53 (IQR 47-60) kg, BMI 19.3 (17.4-21.5) kg/m2 and MUAC 24.0 (22.0-26.1) cm. Participants were randomized to RUSF (n=897) or no RUSF (n=908) with ART. 25 (2.8%) and 39 (4.3%) respectively received RUTF, following local guidelines. Follow-up was 48 weeks (3.1% loss-to-follow-up). Gains in weight, BMI (Figure) and MUAC were greater in the RUSF group (p=0.004, 0.004, 0.03). Maximum differences were at 12 weeks; +3.8 RUSF versus +2.9 kg no-RUSF, +1.4 versus +1.1 kg/m2, and +1.2 versus +1.0 cm respectively. Changes in weight with RUSF were predominantly due to gains in fat mass by bioimpedance analysis. There were no differences in grip strength between groups (p=0.36). 96 (10.9%) RUSF versus 92 (10.3%) no-RUSF died before 24 weeks (stratified hazard ratio=1.05 (95% CI 0.79-1.40) p=0.75) (to 48-weeks p=0.87), with no evidence of interaction with the two other randomizations (p>0.7). There was no difference in time to first WHO 3/4 event or death (p=0.82).

RUSF supplementation at ART initiation in advanced disease improved nutritional status but did not impact mortality.

Session Number: 0-10