Treatment Optimisation Community Condultation Feedback. KENLY SIKWESE AFRICAN COMMUNITY ADVISORY BOARD (AFROCAB) 3 rd May 2016

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1 Treatment Optimisation Community Condultation Feedback KENLY SIKWESE AFRICAN COMMUNITY ADVISORY BOARD (AFROCAB) 3 rd May 2016

2 INTRODUCTION A brief history of ART s AZT vecomes available ddi/ddc 3TC Pis, NNRTIs, NRTIs

3 Africa, 1999: mass treatment for HIV/AIDS is not feasible 3

4 A key moment in the history of HIV My generics company can manufacture HIV antiretrovirals for a dollar per day Dr Yussef Hamied Cipla, G8 summit,

5 New ARVs Could Represent Over USD 3 Billion in Cost Savings Through 2025 Vineet Prabhu, Cebele Wong, Sarah Jenkins, Saman Nizami, Kelly Catlin, Paul Domanico Clinton Health Access Initiative (CHAI) No financial disclosures to report

6 2015 Consolidated Guidelines on the use of ARV drugs for treating and preventing HIV infection WHO Geneva 30 Nov 2015 ICASA

7 WHEN TO START RECOMMENDATIONS Population Specific Recommendation Strength Quality of Evidence Adults Pregnant/BF women Adolescents ART initiation at any CD4 Strong Moderate WHO clinical stage III/IV or CD4 350 as priority ARV initiation at any CD4 and continued lifelong (Option B+) ART initiation at any CD4 if yearsold WHO clinical stage III/IV or CD4 350 as priority Strong Strong Conditional Strong Moderate Moderate Low ART initiation at any CD4 if 1-10 years-old Conditional Low Moderate Children ART initiation at any CD4 if < 1 year-old Strong Moderate if < 2 years-old or WHO clinical stage III/IV or CD4 < 25% (< 5 years) or 350 (>5 years) as priority Strong Moderate

8 1 st line therapy in adults 2nd line therapy in adults 2 NRTI + ATV/r or Preferred Option TDF + XTC+ EFV 600 LPV/r Alternative Options Adults: new 1 st and 2 nd line ARVs for Alternative Regimens In summary first line AZT + 3TC + EFV 600 AZT + 3TC + NVP TDF + XTC 3 + NVP remains TDF/XTC/EVF600; new options DTG, EFV400 and DRV/r as alternatives TDF + XTC 3 + DTG TDF + XTC 3 + EFV NRTI + DRV/r LPV/r + RAL FDC and once daily regimens preferred (strong, moderate) DTG & EFV400 - Safety data PLHIV with TB co-infection and in HIV+ pregnant women still pending; thus not currently recommended

9 Children: Similar 1 st line & greater options for 2 nd line LPV/rfirst line Children & adolescents Younger than 3 years First-line ART regimen ABC+3TC+LPV/r AZT+3TC+LPV/r 3 years First and Line ABC+3TC+ NO CHANGE LPV/r older AZT+3TC+LPV/r Second-line ART regimen AZT or ABC+3TC+RAL AZT+3TC+EFV or RAL ABC or TDF+3TC+EFV or RAL NNRTIfirst-line All ages ABC+3TC+EFV(or NVP) AZT+3TC+ATV/r or LPV/r TDF+3TC+EFV(or NVP) AZT+3TC+EFV(or NVP) Second line MORE OPTIONS including RAL ABC or TDF+3TC+ ATV/r or LPV/r

10 ART monitoring: Viral load Viral load is recommended as the preferred approach to diagnose and confirm treatment failure Viral load failure is defined as persistent viral load <1000 copies Viral load should be measured at 6M, 12M then every 12M (conditional, very low) Dried blood spots can be used to determine viral load (conditional, low)

11 Full roll-out of DTG and TAF? Efficacy and safety for: - Pregnant women - During rifampicin-based treatment for TB Studies to answer DTG/TAF in some populations is critica;

12 Community priorites for TO ViiV Health Care and Gilead must urgently donate durgs for researching missing data in pregnancy/tb Provide annual updates on DTG/TAF in pregnancy/tb Annual meetings with manufacturers starting with Durban 2016 Regulatory issues must be addressed to make DTG/TAF accessible in Africa Generic manufacturung must be supported for rapid production scale up and competition to reduce price Treatment literacy is needed for community groups address gaps AFROCAB will support Tx optoisation meeetings in-county AFROCAB/TAC//HIV i-base will host a community ART meeting $90--$90-$90 Campaign ARVs - Hep B Hep C

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