WHO 2013 Consolidated ARV Guidelines What is new for PMTCT and Paediatric HIV Care and Treatment? Nathan Shaffer PMTCT Technical Lead, WHO 8th Interest Workshop Lusaka, Zambia 5 May 2014

Excellent healthcare – locally delivered

Objectives of Presentation

o Context of new consolidated guidelines o Adult recommendations o Pregnant and breastfeeding women o Children o Emerging issues and future directions o Summary

Why new WHO guidelines in 2013…?

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Advances in science/technology and in vision

 Technologies (incl. PoC CD4 and VL, new drug 

•

HIV as a chronic health condition

 Increasing focus on treatment adherence and retention in 

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formulations) ART for individual and population benefits

care Chronic care models – decentralization, integration

Despite scale-up, continuing challenges

 

Low ART coverage among children, adolescents and key populations Major gaps in quality and in retention along the continuum of care

WHO 2013 Consolidated ARV Guidelines WHAT TO DO? • When to start or switch • Which regimen to use • How to monitor • Co-infections & co-morbidities

HOW TO DECIDE? • Prioritization • Equity and ethics • Monitoring & Evaluation

Clinical

Operational

Guidance for Programme Managers

HOW TO DO IT? • Service delivery • Diagnostics • Drug supply

Concept Behind Consolidation

• • •

Consolidation across populations and ages Consolidation along the continuum of care

Consolidation of new with existing guidance

Simpler, less toxic drugs

Point of care diagnostics

Delivery models

Summary of Changes in Recommendations When to Start in Adults TARGET POPULATION (ARV-NAIVE)

2010 ART GUIDELINES

2013 ART GUIDELINES

HIV+ ASYMPTOMATIC

CD4 ≤350

HIV+ SYMPTOMATIC

WHO clinical stage 3 or 4 No change regardless of CD4 cell count

PREGNANT AND BREASTFEEDING WOMEN WITH HIV HIV/TB COINFECTION HIV/HBV COINFECTION

cells/mm3

CD4 ≤350 cells/mm3 or WHO clinical stage 3 or 4 Presence of active TB disease, regardless of CD4 cell count Evidence of chronic active HBV disease, regardless of CD4 cell count

HIV+ PARTNERS IN No recommendation SD COUPLE established

CD4 ≤500 cells/mm3 (CD4 ≤ 350 cells/mm3 as a priority)

Regardless of CD4 cell count or WHO clinical stage No change Evidence of severe chronic HBV liver disease, regardless of CD4 cell count Regardless of CD4 cell count or WHO clinical stage

STRENGTH OF RECOMMENDATION & QUALITY OF EVIDENCE

Strong, moderatequality evidence

Strong, moderatequality evidence Strong, moderatequality evidence Strong, low-quality evidence Strong, low-quality evidence Strong, high-quality evidence

Summary of Changes in Recommendations: What to Start in Adults FIRST-LINE REGIMENS (PREFERRED ARV REGIMENS) TARGET POPULATION

2010 ART GUIDELINES

HIV+ ADULTS

AZT or TDF + 3TC (or FTC) + EFV or NVP

HIV+ PREGNANT WOMEN

AZT + 3TC + NVP or EFV

HIV/TB AZT or TDF + 3TC (or CO-INFECTION FTC) + EFV TDF + 3TC (or FTC) + HIV/HBV CO-INFECTION EFV

2013 ART GUIDELINES

STRENGTH & QUALITY OF EVIDENCE

TDF + 3TC (or FTC) + EFV Strong, moderate(as fixed dose quality combination) evidence

Rationale: One Regimen For All Preferred 1st line regimen: TDF + 3TC (or FTC) + EFV

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Simplicity: regimen is very effective, well tolerated and available as a single, once-daily FDC and therefore easy to prescribe and easy to take for patients – facilitates adherence Harmonizes regimens across range of populations (Adults, Pregnant Women (1st trimester), Children >3 years, TB and Hepatitis B) Simplifies drug procurement and supply chain by reducing number of preferred regimens (phasing out d4T) Safety in pregnancy Efficacy against HBV EFV is preferred NNRTI for people with HIV and TB (pharmacological compatibility with TB drugs) and HIV and HBV coinfection (less risk of hepatic toxicity) Affordability (cost declined significantly since 2010)

Recommendations: VL Monitoring for ART Response RECOMMENDATION

STRENGTH

Viral load is recommended as the preferred Strong monitoring approach to diagnose and recommendation, confirm ARV treatment failure low-quality evidence If viral load is not routinely available, CD4 count and clinical monitoring should be used to diagnose treatment failure

Strong recommendation, moderate-quality evidence

2013 ARV Consolidated Guidelines

Pregnant and Breastfeeding Women

Evolution of WHO PMTCT ARV Recommendations

2006

2010

Launch June 2013

PMTCT

2004

4 weeks AZT; AZT+ 3TC, or SD NVP

AZT from 28 wks + SD NVP

AZT from 28wks Option A Option B or B+ + sdNVP (AZT +infant NVP) Moving to ART +AZT/3TC 7days Option B for all PW/BF (triple ARVs)

ART

2001

No recommendation

CD4