1. The 2013 treatment guidelines and key implementation challenges Martina Penazzato IATT Normative Guidance Advisor HIV Department, WHO (Geneva, Switzerland)

2. Outline Progress update Guidelines uptake Drug optimization Future trends in paediatric Moving forward

3. New Infections 240 000 [210 000–280 000] new infections in 2013 In 2013, about two thirds (67%, range 62–73%) of all pregnant women living with HIV in LMIC received ARVs to prevent mother- to-child transmission

4. EID gap 60% Treatment gap 76% Source: Global AIDS Response Progress Reporting (WHO/UNICEF/UNAIDS); number of pregnant women living with HIV as a proxy for HIV-exposed infants: UNAIDS 2013 estimates EID coverage in 2013 44% 520 000 HIV-exposed Infants received a virological test in 88 reporting countries

5. Source: UNAIDS ART coverage 12% Source: UNAIDS / WHO / UNICEF

6. 20% 12% 67% 38% % % Age < 5 yrs Age < 2 yrs % Other 40% 33% 17% 20% 80% Uptake of 2013 recommendations as of July 2014 40% 38% Uptake based on 58 WHO focus countries, by regio n 25% 20% 40% Total 22% 21% 50% 40% 20% Total 21% Total 48% 2013 Guidelines Uptake (When)

7. Choosing a preferred regimen Children < 3 yearsChildren 3 years to < 10 years Adolescents > 10 years PreferredABC + 3TC + LPV/r or AZT + 3TC + LPV/r ABC + 3TC + EFVTDF + 3TC + EFV Alternative ABC + 3TC + NVP AZT + 3TC + NVP ABC + 3TC + NVP AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + EFV TDF + 3TC (or FTC) + NVP AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + NVP

8. Availability of formulations impacts implementation Two formulations of LPV/r are available: LPV/r 100 mg/25 mg heat-stable tablet for children >10 kg and LPV/r oral liquid 80/20 mg per 1 ml for use among infants. TDF is currently available in 3 different formulations for use across weight bands but a TDF-containing FDC is yet to be developed

9. 2013 Guidelines Uptake (What in > 3years) EFV recommended as preferred NNRTI Recommended Not Recommended AMRO, EURO and WPRO prefer EFVAZT + 3TC mostly recommended In AFRO region several countries prefering ABC + 3TC

10. 2013 Guidelines Uptake (What in < 3years) LPV/r based-regimens Preferred Not Preferred Not preferred, but recommended Zidovudine and Abacavir preferences AZT ABC AMRO, EMRO, and WPRO regions predominantly AZT. AFRO, EURO and SEARO regions prefer ABC. AMRO and EURO regions prefer LPVr SEARO, WPRO and AFRO present significant diversity

11. Optimize existing products

12. Establishing priorities Mid-term priorities  More potent drugs for second line in young children  DRV/r or RAL as the 3 rd line options Long-term priorities  INT in 1st line as opportunity for full harmonization  NNRTI left for 3rd line combinations

13. Future trends Understand the size of the population of children expected to be in need of ART in the future Characterize this population to inform drug and formulation development Understand the impact of different monitoring strategy to quantify the need for first and second line products

14. Moving forward Assist countries in their adoption of WHO recommendations Enable rapid phase in and phase out of commodities (drugs and diagnostics) Develop better drugs and better formulation that provide better treatment option, enhance adherence and facilitate treatment optimization Expand use of service delivery models that enable decentralization, integration and task-shifting Engage the community

15. Choosing a preferred regimen Children < 3 yearsChildren 3 years to < 10 years Adolescents > 10 years PreferredABC + 3TC + LPV/r or AZT + 3TC + LPV/r ABC + 3TC + EFVTDF + 3TC + EFV Alternative ABC + 3TC + NVP AZT + 3TC + NVP ABC + 3TC + NVP AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + EFV TDF + 3TC (or FTC) + NVP AZT + 3TC + EFV AZT + 3TC + NVP TDF + 3TC (or FTC) + NVP

16. Acknowledgments PADO/PAWG members Nathan Ford Nathan Shaffer Chika Hayashi Mary Mahy Meg Doherty Gundo Weiler Gottfried Hirnschall