1 Impacts of Specialized Food Products on HIV-infected Adults and Malnourished Children: Emerging Evidence from Randomized Trials Tony Castleman International Food Aid Conference April 15, 2008

2 Outline 1.Background 2. CSB vs. RUFS for Adult ART Clients in Malawi 3. FBF vs. No Food for HIV+ Adults in Kenya 4.CSB vs. milk-peanut RUTF vs. soy- peanut RUTF for children with moderate acute malnutrition in Malawi 5. Conclusions and Future Directions

3 Background: Food and HIV Strong evidence on association between PLHIV nutritional status and mortality. Much less evidence on impacts of nutrition interventions for PLHIV. ART itself improves nutritional status but can also create additional nutrition issues.

4 Background: Specialized Food Products Fortified blended foods (FBF) –CSB has a long history of use in a range of programs with various objectives –In many settings it is a more nutritious form of commonly used staple foods –Questions have been raised about its effectiveness in addressing malnutrition –Efforts to improve CSB have begun

5 Background: Specialized Food Products Ready-to-use foods –Ready-to-use therapeutic food (RUTF) was developed – and is very effective – for children with severe acute malnutrition –Recent expansion to other populations: HIV+ adults, moderately malnourished children –May not be optimal food for all groups; adaptations and alternative formulations are underway –RUFs are relatively expensive, and cost- effectiveness is a consideration

6 CSB vs. RUFS for Adult ART Clients: Research Question For malnourished adults starting ART, does food supplementation with ready- to-use fortified spread (RUFS) improve nutritional and clinical status more than food supplementation with CSB does?

7 CSB vs. RUFS for Adult ART Clients: Design Randomized, investigator-blinded effectiveness trial. Implemented at Queen Elizabeth Hospital, Malawi by Washington Univ. at St. Louis (Mark Manary, PI). Non-pregnant adults starting ART with BMI < 18.5 kg/m 2 (average 16.5 kg/m 2 ).

8 374 g./day CSB (1,360 kcal/day) for 3.5 months n=246 Enrollment n=491 Randomization CSB vs. RUFS for Adult ART Clients: Design 260 g./day RUFS (1,360 kcal/day) for 3.5 months n=245

9 CSB vs. RUFS for Adult ART Clients: Results

10 CSB vs. RUFS for Adult ART Clients: Results

11 CSB vs. RUFS: Results After 3.5 months of supplementation - Above differences were statistically significant. - Differences in CD4, survival, QOL, adherence were not significant. - At 3, 6, 9 months after food ended, there were no significant differences in any outcomes. - RUFS is approx. 3X the cost of CSB. Weight GainFat-Free Mass Gain CSB4.3 kg2.2 kg RUFS5.6 kg2.9 kg

12 CSB vs. RUFS for Adult ART Clients: Results Subjects included mild, moderate, and severely malnourished. Difference between RUFS and CSB may be greater among severely malnourished. High case fatality rate –27% after 3.5 months of food –43% after 12.5 months (3.5 food + 9 follow-up)

13 FBF vs. No Food for HIV+ Adults: Research Question Does food supplementation of malnourished HIV-infected adult ART and pre-ART clients improve nutritional status, clinical outcomes, and drug adherence?

14 FBF vs. No Food for HIV+ Adults: Design Randomized effectiveness trial. Implemented at 6 HIV treatment sites in Kenya by Kenya Medical Research Institute (KEMRI). Non-pregnant ART adult clients with BMI < 18.5 kg/m 2. Pre-ART adults clients taking cotrimoxazole with BMI < 18.5, or with weight loss.

15 FBF vs. No Food for HIV+ Adults: Design 6 months of 1,320 kcal/day fortified blended food (corn, soy, oil sugar, whey concentrate, MN) + nutrition counseling OR nutrition counseling alone

16 Nutrition counseling n=~315 ART Enrollment n=~630 Randomization FBF vs. No Food for HIV+ Adults: Design 300 g./day FBF + counseling n=~315 Nutrition counseling n=~210 pre-ART Enrollment n=~420 Randomization 300 g./day FBF + counseling n=~210

17 CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children: Research Question How do CSB, milk-peanut RUTF, and soy-peanut RUTF compare in helping children recover from moderate acute malnutrition?

18 CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children: Design Randomized effectiveness trial. Children aged months with -3 < WHZ < weeks of CSB or peanut-milk RUTF or soy- peanut RUTF. Implemented at 7 supplementary feeding sites in Malawi by Washington Univ. at St. Louis (Mark Manary, PI).

19 75 kcal/kg/day CSB n=~450 Enrollment n=~1,350 Randomization CSB vs. milk-RUTF vs. soy-RUTF: Design 75 kcal/kg/day soy-peanut RUTF n=~ kcal/kg/day milk-peanut RUTF n=~450

20 CSB vs. milk-RUTF vs. soy-RUTF for moderately malnourished children: Preliminary Results All groups had good recovery rates, with RUTF groups somewhat better Milk-peanut RUTF is 4X the cost of CSB and soy-peanut RUTF is 2X the cost of CSB

21 Conclusions & Future Directions Need to balance effectiveness and cost- effectiveness. Program settings may matter in identifying most effective (and cost- effective) food products for a given target population, e.g. clinical vs. community setting.

22 Conclusions & Future Directions Reports of CSB’s demise may be exaggerated: FBF products can help achieve nutrition objectives for some target groups. Need to adapt and enhance formulations of both types of products for specific target groups and objectives.

23 (RUSF; RUFS; use soy instead of milk) Conclusions & Future Directions (enhanced FBFs)