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HIV Treatment for Adults and Adolescents

HIV Treatment for Adults and Adolescents. Stefano Vella MD Istituto Superiore di Sanità - Rome - Italy. WHO 2013 Guidelines contribution to fill the treatment g ap. Operational / Programmatic Guidance Improve testing coverage, address late presentation

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HIV Treatment for Adults and Adolescents

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  1. HIV Treatment for Adults and Adolescents Stefano Vella MD IstitutoSuperiore di Sanità - Rome - Italy

  2. WHO 2013 Guidelines contribution to fill the treatment gap • Operational / Programmatic Guidance • Improve testing coverage, address late presentation • Optimize care delivery models: • offer something meaningful in the pre-art period, • task sharing, decentralization and integration of care, address attrition • community involvement • procurement • Clinical Guidance • Improve the quality of drugs • Simplify and harmonize 1st line regimens • Perfect monitoring • Streamline subsequent treatment lines • Consider co-infections and co-morbidities

  3. WHO’s 2013 Guidelines: the challenge To find the right balance between: the “individualized” approach to ART….. and the “public health” approach needed to start and maintainon ART over 20 millionpersons….… ….considering the different HIV epidemics ….whilekeeping the same - evidence-based- standard of care!

  4. When to start ART: what is new since 2010 ? • Strong evidence of the impact of ART on HIV transmission: • HPTN 052 study • Emerging data on the impact of ART on HIV incidence at the population level • Increasing evidence on clinical benefits of early ART initiation: • Observational studies showing impact on HIV mortality and morbidity • Scientific insights on HIV immunopathogenesis and on the effects of chronic inflammation associated with HIV infection • Better regimens: • Better tolerable drugs • Better formulations • New classes

  5. When to start ART 2013 WHO consolidated Guidelines Evaluating Risks & Benefits of earlier ART initiation Potential risks • long-term adverse effects / toxicities • limitation of future treatment options (with drug resistance concerns) •  stigma & discrimination • ↓ long term adherence ? •  burden on healthcare infrastructure / feasibility •  immediate cost Potential benefits • ↓ risk of HIV transmission (sexual and vertical) • ↓ risk of TB disease • ↓ risk of serious non-AIDS conditions (HBV disease, cardiovascular disease, renal disease, liver disease, cancers) •  linkage to care • chance to achieve higher CD4 values (immune recovery) • ↓ long term costs (infections and co morbidities averted)

  6. When to start in adults: what is new in the 2013 Guidelines Considering both the individual and the Public Health benefit…. • Threshold moved to < 500 CD4 • Priority for reaching all HIV+ symptomatic persons and those with CD4 ≤ 350 • More CD4-independent situations for ART initiation (in addition to HIV/TB coinfection and HBV advanced liver disease): • HIV serodiscordant couples, • Pregnancy • Children less than 5 years of age GL are a “tool” for countries to produce their own guidelines: theywilladaptthe new threshold(s) with operational / programmaticlocalcontext

  7. Major Guidelines for Initiation of Antiretroviral Therapy • (1) Strong strength recommendation based on observational data (A-II) • (2) Moderate strength recommendation based on expert opinion (B-III). • (3 ) But treat all HIV+ pregnant women, HBV co-infection, HCV co-infection, HIVAN, HIV related neurocognitive disorders, ITP, non-AIDS cancers and serodiscordant couples • (4) Individuals with CD4 < 350 as a priority. • (5) But treat all HIV+ pregnant women ,TB co-infection with active disease and HBV co-infection with severe liver disease, and serodiscordantcopuls

  8. 2013 WHO consolidated Guidelines What ARV regimens to be used in adults • One-pill-a-day FDC as preferred 1stline(s) • Reducing the number of preferred regimens • Defining substitution regimens • Harmonizing regimens across different target populations (TB, Hepatitis B, Pregnant Women)

  9. 2013 WHO consolidated Guidelines One regimen cannot fit all: alternative, special situations

  10. Challenges ahead (i): current NRTIs

  11. Phasing out d4T: trends of d4T, AZT and TDF use in adults first line ART (2006 – 2012 ) 70% 44% 27.9% 27.9% N= 12 countries HIV/AIDS Department

  12. Challenges ahead (ii): second-line regimens

  13. Comparative Analysis of ATV/r , LPV/r and DRV/r

  14. Need to move forward: towards the 2015 guidelines….. New drugs and new combinationsshallbe made available, globally, ataffordableprice, whenpossibleasFDCs • Additional 1st line options • Better 2nd / 3rd lines • New strategies • (if proven effective)

  15. 2013 WHO ART Guidelines in Adults: a summary Earlier initiation Simpler treatment Less toxic, more robust regimens Better monitoring HIV/AIDS Department

  16. 2013 WHO ART Guidelines in Adults: a summary Earlier initiation Simpler treatment Less toxic, more robust regimens Better monitoring Evidence-based, butintentionallyaspirational… HIV/AIDS Department

  17. MONITORING ART RESPONSE Targeted viral load monitoring (suspected clinical or immunological failure) Routine viral load monitoring (early detection of virological failure) Test viral load Viral load >1000 copies/ml 70% greaterresuppression rate after adherence intervention 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 Viral load as a tool to reinforce adherence and discriminate between treatment failure and non-adherence: need to expand the availabity of point-of care diagnostics

  18. 2013 WHO consolidated Guidelines A “game changer” document, and an importantstep towards the global alignment of theHIV standard of care

  19. Acknowledgements Special thanks to all members of the Guideline Development Groups, the Peer Review panel and to those who contributed to the GRADE systematic reviews and supporting evidence which informed the guidelines process. Guideline Development Group Co-chairs: Anthony Harries, Gottfried Hirnschall Elaine Abrams (International Center for AIDS Care and Treatment Programs, Mailman School of Public Health, Columbia University, USA) Tsitsi Apollo(Ministry of Health and Child Welfare, Zimbabwe) Kevin De Cock(United States Centers for Disease Control and Prevention, USA) Serge Eholie(ANEPA/Treichville Hospital, Abidjan, Côte d’Ivoire) AdeebaKamarulzaman(University of Malaya, Malaysia) YoganPillay(National Department of Health, South Africa) Denis Tindyebwa(African Network for the Care of Children Affected by AIDS, Uganda) Stefano Vella(IstitutoSuperiore di Sanità, Italy) WHO Department of HIV Andrew Ball Philippa Easterbrook Meg Doherty Eyerusalem Kebede Negussie Nathan Shaffer Lulu Muhe Nathan Ford Marco Vitoria Joseph Perriëns Guideline Development Group Pedro Cahn (FundaciónHuesped, Argentina), Alexandra Calmy (University of Geneva, Switzerland), Frank Chimbwandira (Ministry of Health, Malawi), David Cooper (University of New South Wales and St Vincent’s Hospital, Australia), Judith Currier (UCLA Clinical AIDS Research & Education Center, USA), François Dabis (School of Public Health (ISPED) of the University Bordeaux Segalen, France), Charles Flexner (Johns Hopkins University, USA), TendaniGaolathe (Princess Marina Hospital, Botswana), Beatriz Grinsztejn (FundaçãoOswaldo Cruz – FIOCRUZ, Brazil), Diane Havlir (University of California at San Francisco, USA), Charles Holmes (Centre for Infectious Disease Research in Zambia, Zambia), John Idoko (National Agency for the Control of AIDS, Nigeria), KebbaJobarteh (Centers for Disease Control and Prevention, Mozambique), EllyKatabira (Makarere University, Uganda), NagalingeswaranKumarasamy (Y.R. Gaitonde Centre for AIDS Research and Education, India), VolodymyrKurpita (All-Ukrainian Network of People Living with HIV, Ukraine), Karine Lacombe (AgenceNationale de Recherchesur le Sida et les HépatitesVirales (ANRS), France), Albert Mwango (Ministry of Health, Zambia), Leonardo Palombi (DREAM Program, Community of Sant’Egidio, Rome, Italy), Anton Pozniak (Chelsea and Westminster Hospital, United Kingdom), Luis Adrián Quiroz (DerechohabientesViviendo con VIH del IMSS, Mexico), KiatRuxrungtham (Chulalongkorn University, Chula Vaccine Research Center, King Chulalongkorn Memorial Hospital, Thailand), Michael Saag (University of Alabama at Birmingham, USA), Gisela Schneider (German Institute for Medical Mission, Germany), YanriSubronto (UniversitasGadjahMada, Indonesia) and Francois Venter (University of the Witwatersrand, South Africa)

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