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Group Work Recommendations-When to Start Group C.

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Presentation on theme: "Group Work Recommendations-When to Start Group C."— Presentation transcript:

1 Group Work Recommendations-When to Start Group C

2 General Considerations In considering what to start with in infants, need to consider: All infants vs infants with PMTCT exposure esp to NVP Availability and formulations PK data – are we giving the right dose? PMTCT coverage rates will make a difference both in terms of reducing the need, but also changing the field around the likelihood of having resistant virus in the baby… We anticipate that coverage rates will increase which in turn will change the way in which guidelines are implemented Changing from sd NVP to NVP plus additional ARVs takes time, and in any case, many women present late for PMTCT and so only receive sd NVP

3 PopulationUnder one year InterventionSee next slide Notes See next slide What to Start ART

4 No exposure Exposure Sd NVP or NNRTI containing ART Non NNRTI exposure unknown NVP triple ART PI triple ART NVP triple ART Footnotes: If no PI is available use NVP triple ART Future studies may provide data on both stopping ART and switching from PI triple ART to NNRTI triple ART Note that the ACTG 1060 trial should continue despite these recommendations

5 Evidence – Start QualityComment Low or weak Dont have results of head to head comparison of NVP vs Lop/r in infants, but we do know that resistance to NVP in babies is present after NVP exposure in PMTCT (and this is present after BOTH sd NVP and sd NVP plus ZDV for PMTCT). Note also that the link between the presence of resistance and clinical outcome is not well established (esp in infants) CHER does show good clinical outcome using LPV/r in NVP exposed infants (virology coming) NVP and 3TC have low barrier to resistance,whereas LPV/r has high genetic barrier for resistance so this may be a better drug for infants as they have: very high VLs (very good evidence) it takes a long time for VL to become suppressed – so period of drug exposure in the setting of high viral replication is long Additional evidence is coming from several studies inc NEVEREST (start with LPV/r from 6 m, then once suppressed randomize to switch to NVP or cont LPV/r), ACTG 1060 (start at 6m and randomize to either NVP or LPV/r in sdNVP exp vs not exposed infants), Kenya genetic testing study, Arrow study (using 4drugs ZDV 3TC ABC NVP induction then ABC 3TC NVP or ABC 3TC AZT), PENPACT 1 (dir comp of NNRTI vs PI ART in Europe (PENTA) and US)

6 Benefits and Desired Effects – Start Benefit Explanation Will achieve better duration of first line therapy for these infants Maintains more cost effective approach using NVP containing regimen in infants that are likely not to have NVP resistance Use of PI with high resistance barrier in infants that are likely to have NVP resistance Protects 3TC..

7 Risks or Undesired Effects – Start RisksExplanation Increased complexity of treatment algorithm Cost of LPV/r syrup Adherence may be more of an issue Co treatment with TB difficult Dosing needs clarification in youngest infants May derail treatment programs for children by making them more complex LPV/r is not as well tolerated as a syrup (and this is the only option for infants) No FDC formulations for PI containing ART Both NVP and LPV/r may cause problems with TB co therapy Need to work on finalizing dosing for young infants (pk data not so good for LPV/r)

8 Risks/Benefit Assessment – Start DecisionExplanation

9 Feasibility – Start DecisionExplanation Moderate recommendation Need to have refrigeration Palatability an issue with LPV/r syrup LPV/r sprinkles may be an option in the future

10 Costs – Start DecisionExplanation Weak recommendation LPV/r much more expensive than NNRTI Needs a liquid formulation Unlikely to be co-formulated with other drugs into an FDC

11 Recommendations - What to Start ART POPULATIONUnder one year1- 4 yrs> 5yrs START ART See table Strength of Recommendation Overall strong recommendation even though significant programmatic caveats

12 Key Outstanding Questions IssueResearch or action required NVP resistance in InfantsNeed to understand extent and evolution of NVP resistance in babies post PMTCT using sd NVP and combinations with sd NVP LPV/r PKNeed to look at LPV/r PK in infants on Rx

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