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…??? Regulatory issues, drug pricing, generics, TRIPS, compulsory licensing, fixed dose combinations

’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?

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

’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?

Comparison of 1 st and 2 nd 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.

’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

’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’

Progress towards the "3 by 5" target Dec 2003Jun 2004Dec 2004June 2005Dec 2005 Target Actual progress (people in need of ART in millions)

Progress in regions Africa LA and Caribbean Asia and Pacific Eastern Europe North Africa & Middle East ( estimated number of people on ART in thousands ) Progress level at June 2005 Progress level at June

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

Antiretroviral therapy coverage in low- and middle-income countries, by region Situation as of June 2005 Geographical regionNumber of people receiving ARV therapy (low estimate – high estimate) Estimated need Coverage Sub-Saharan Africa ( – ) % Latin America and the Caribbean ( – ) % East, South and South-East Asia ( – ) % Europe and Central Asia ( – ) % North Africa and the Middle East4 000 (2 000 – 6 000) % Total ( – )6.5 million15%

Unmet need > < high-burden countries represent 85% of global unmet need.

‘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?

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

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

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

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

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

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