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WHO 2013 ARV Guidelines Launch

WHO 2013 ARV Guidelines Launch. Dr. Meg Doherty, WHO, G eneva Coordinator Treatment and Care. Critical issues for Adults with HIV: Presentation of Systematic reviews and Main recommendations. Objectives of Presentation.

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WHO 2013 ARV Guidelines Launch

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  1. WHO 2013 ARV Guidelines Launch Dr. Meg Doherty, WHO, Geneva Coordinator Treatment and Care Critical issues for Adults with HIV: Presentation of Systematic reviews and Main recommendations

  2. Objectives of Presentation • Overview of Evidence Base and Rationale for Recommendations for Adults: • When to Start ART • What ART to Start (First-Line) • What ART to Switch to (Second-Line) • How to Monitor ART

  3. When to Start ART

  4. Summary of Changes in Recommendations When to Start in Adults

  5. Evidence Summary: When to Start in Adults • Systematic Review of 24 studies (3 RCTs, 21 observational ) • Multiple countriesthroughout Europe, North America, Central & South America, sub-Saharan Africa and Asia-Pacific • Outcomes reported: • mortality • progression to AIDS • progression to AIDS or death • non-AIDS defining cancer • serious non-AIDS events • CD4 increase • viral suppression, failure, rebound • SAE and grade 3 or 4 lab abnormalities

  6. Evidence Summary:Risk of Death and/or Progression to AIDS RCTs – SMART / HPTN 052 Observational data Risk of Death or Progression to AIDS Clinical Trials (2 RCTs) Low quality evidence for lower risk of progression to AIDS or death with early ART Observational studies Moderate quality evidence for lower risk of death (13 studies) or progression to AIDS (9 studies) with early ART Risk of Death Risk of Progression to AIDS

  7. Evidence Summary:Risk of HIV Sexual Transmission Clinical Trial - HPTN 052 Observational data RCT on efficacy of ART to prevent HIV transmission between discordant couples HIV+ partner with CD4 ≥ 350-550 cells/µL randomized to early vs. delayed ART Significant HIV prevention benefit – a 96% reduction in transmission. 1 genetically linked infection in early ART arm versus 29 infections in delayed arm. Early ART Late ART RCT and Observational data • High to moderate quality evidence that treatment prevents sexual transmission of HIV (1 RCT and observational data)

  8. Populations With No Specific Recommendations • Insufficient evidence and/or favorable risk-benefit profile for ART initiation at CD4 > 500 cells/mm3 (or regardless of CD4 count) in the following situations: • Individuals with HIV who are 50 years of age and older • Individuals co-infected with HIV and HCV • Individuals with HIV-2 • Key populations with a high risk of HIV transmission (e.g.: MSM, sex workers, IDU) These populations should follow the same principles and recommendations as for other adults with HIV

  9. WHAT ART REGIMEN TO START

  10. Summary of Changes in Recommendations: What to Start in Adults

  11. Evidence Summary: What to Start Immunologic Response (48 weeks) • Systematic review (10 RCTs): TDF+3TC (or FTC)+EFV superior vs. other EFV containing regimens and vs. TDF/3TC+ PI/r on major outcomes - occurrence of SAEs, virologic and immunologic response (high to moderate quality of evidence) • Systematic review (7 RCTs, 27 observational): NVP > 2 fold more likely to be discontinued due any adverse effect compared to EFV (moderate to low quality of evidence) • Systematic review of preclinical data (5 studies): support pharmacological equivalence interchangeability of 3TC and FTC (low quality evidence) Virologicalresponse (48 weeks) Severe adverse events (48 weeks) Discontinuation NVP vs. EFV Comparative efficacy 3TC and FTC

  12. WHAT ART TO SWITCH TO

  13. Summary of changes to recommendations: What ART to Switch to

  14. Rationale: Comparative Analysis of ATV/r, LPV/r and DRV/r

  15. HOW TO MONITOR AND WHEN TO SWITCH

  16. Recommendations: Monitoring for ART Response 6 studies (4 RCTs and 2 observational studies) • Clinical+Immunological versus Clinical+Immunological+Virological: (1 RCT + 1 obs study ): no difference in terms of mortality and new AIDS-defining • Clinical+Immunologicalversus Clinical+Virological: (1 RCT): no difference in clinical failure , switch to second line regimens , and resistance mutations . Children (Arrow 2013): mortality and disease progression are comparable between clinical and laboratory monitoring

  17. Rationale: for VL Targeted viral load monitoring (suspected clinical or immunological failure) Routine viral load monitoring (early detection of virological failure) • Earlier capture of treatment failure & reducing HIVDR • Help discriminate between treatment failure & non-adherence • Lack of viral load or CD4 capacity should not prevent starting ART • If VL availability limited, phase in use of targeted approach (or CD4/clinical monitoring) • Same for adults & children Test viral load Viral load >1000 copies/ml Evaluate for adherence concerns Repeat viral load testing after 3–6 months Viral load ≤1000 copies/ml Viral load >1000 copies/ml Maintain first-line therapy Switch to second-line therapy

  18. Predictive value of WHO immunological and clinical criteria

  19. Summary of Adult Guidelines Earlier initiation Simpler treatment Less toxic, more robust regimens Better monitoring

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