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ART: The Basics

ART: The Basics. William Aldis World Health Organization Bangkok, September 14, 2005. ’ART’: the Basics. The virus The disease Basics of treatment Setting national treatment policy Scaling up: Global progress (‘3x5’) Treatment versus prevention…???

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ART: The Basics

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  1. ART: The Basics William Aldis World Health Organization Bangkok, September 14, 2005

  2. ’ART’: the Basics The virus The disease Basics of treatment Setting national treatmentpolicy Scaling up: Global progress (‘3x5’) Treatment versus prevention…??? Regulatory issues, drug pricing, generics, TRIPS, compulsory licensing, fixed dose combinations

  3. ’ART’: the Basics • What is “AIDS’? Why do we call the disease ‘HIV/AIDS’? • What about the HIV virus? What is a virus? What is a ‘retrovirus’? • Why are there so many drugs, and why does each patient need to take several at the same time? Why not just one good drug? • Why do we need first line, second line and other alternate therapies?

  4. ’ART’: the Basics ART? ARV? AIDS? VCT? ddl? Didanosine? 3TC? Lamivudine? d4t? Stavudine? ZDF? Zidovudine? AZT???? NVP? Nevirapine? EVF? Efavirenz? Tenofovir? FTC? Emtricitabine? ??????

  5. ’ART’: the Basics “d4T or ZVD + 3TC + NVP or EFV” …what does that mean? Why should I care? How does a national programme decide on a regimen?

  6. Comparison of 1st and 2nd Line ARV Drug Formularies for Adults and Adolescents (2003 vs 2005) NFV, APV/r and Fos-APV/r can be considered as alternatives of PI components. NFV doesn't need refrigeration. 3TC can be maintained in 2nd line to promote the reduction of viral fitness.

  7. ’ART’: the Basics How does a national programme decide on treatment regimen (first and second-line)? - cost - potency - laboratory monitoring (CD4, HGB) - cold chain - TB, hepatitis burden - drug resistance

  8. ’ART’: the Basics What other decisions must a national programme make on ART? - laboratory services - treatment protocols - training, staff qualifications, HR - drug logistics (? cold chain for some) - facility standards and monitoring - provision of VCT (!!!!) - continuum of care - … ‘treatment vs. prevention’

  9. Progress towards the "3 by 5" target 3.0 (people in need of ART in millions) Target 2.5 2.0 1.5 Actual progress 1.0 0.5 Dec 2003 Jun 2004 Dec 2004 June 2005 Dec 2005

  10. Progress level at June 2005 Progress level at June 2004 Progress in regions 600 (estimated number of people on ART in thousands) 500 000 500 400 290 000 300 200 155 000 100 20 000 4 000 Asia and Pacific Eastern Europe North Africa & Middle East LA and Caribbean Africa

  11. Estimated number of people on ART has more than doubled in South-East Asia, 2003-2005! Estimated Number of People Jul-05 Dec-04 Dec-03 Year Target by the end of 2005: 450,000 (20% coverage)

  12. Unmet need > 400 000 100 000-400 000 < 100 000 20 high-burden countries represent 85% of global unmet need.

  13. ‘treatment vs. prevention’ • a false argument • results from peculiarities of history of HIV/AIDS • treatment and prevention programmes are mutually reinforcing! • you can’t have an ART programme without VCT (where would you find the patients??) • There are preventive measures for all diseases- do we ignore treatment for other diseases because prevention is more cost-effective?

  14. Rate (%) P’ = P + X I P I I = D I = D D X Time (yr.) 100% ARV Death Constant Prevalence P = Prevalence I = Incidence D = Death rate X = Extended life

  15. Rate (%) P P’ D D’ I I’ X Time (yr.) 100% ARV Death Declining Prevalence P = Prevalence I = Incidence D = Death rate X = Extended life

  16. Rate (%) P’ P I I D D X Time (yr.) 100% ARV Death Increasing Prevalence P = Prevalence I = Incidence D = Death rate X = Extended life

  17. ARVs: Regulatory and Licensing Issues • World Trade Organization 1995 • TRIPS • Generic drugs- cost and availability • Fixed dose combinations • Compulsory licensing • Parallel Importation

  18. Access to Drugs: WHO Perspectives • Access to essential drugs is a human right • Essential Drugs are not simply another commodity- TRIPS safeguards are crucial • Patent protection has been an essential incentive for research and development for new drugs • Patents should be managed in an impartial way, protecting the interests of the patent holder, as well as safeguarding public health • WHO supports measures which improve access to essential drugs, including application of TRIPS safeguards

  19. d4T/3TC/NVR (triple therapy) 2000: US price about $10,000/year Sept. 2000: Cipla price $350 2001: US price $727 2003: Hetero price $201

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