1. Group Work Recommendations- what to start Group WHAT 1

2. Population< 12 months HIV infected Presumptive severe HIV < 11 months InterventionEarly initiation of ARTSame Regimen to be used PMTCT exposed : PI or close monitoring of NNRTI No PMTCT: NNRTI based with same idem

3. Evidence QualityComments Low HIGH very scarce evidence on efficacy of existing recommendations on NNRTI based regimen Some evidence for lower efficacy of NVP based regimen in NVP exposed vs non exposed infants Very little/no evidence on treatment of non-sick children with NVP based regimen High : acquisition of NNRTI resistance after PMTCT exposure PI based regimen effective in NNRTI resistant patien

4. Benefits and desired effects DecisionExplanation Assumption/extrapolation: With PI based regimen better chance of efficacy in NVP-exposed kids, esp. in early treatment Protection from development of NRTI-resistance

5. Risks or undesired effects RiskExplanation ModerateLong-term toxicity unknown Toxicity : Gastro-enteritis PI not available for 2 nd line therapy No FDC – lower adherence Palatability? – lower adherence

6. Risk/benefits DecisionExplanation StrongBenefits outweigh risks

7. Feasibility Decision Explanation WEAKConditional on availability Storage, Stability at high temperature level ? (one month up to 25°) Logistic supply Cost

8. Costs DecisionExplanation ConditionalHigh

9. Recommendations – What to start ART POPULATION Up to 12 months 1- 4 yrs> 5 START ART PMTCT/NVP exposure : PI-regimen * No PMTCT exposure : NVP-regimen (current recommendations) * In the absence of PI : closed monitoring of 2- NRTI or 3-NRTI +NVP- regimen NVP/EFV+ 2NRTI Strength of recommendation Discuss but strong ! Strong

10. Key outstanding questions IssueResearch or action required More data on resistance, efficacy and virological response in NVP- based and PI-based early regimen in infancy More data on PK, on adherence, acceptability and NRTI back-bone No data on formulations and their use lack of FDC Look for the best long-term strategy after PMTCT Best sequencing of strategies Operational research +++