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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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Art the basics

ART: The Basics

William Aldis

World Health Organization

Bangkok, September 14, 2005


Art the basics1

’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


Art the basics2

’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 basics3

’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 basics4

’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

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.


Art the basics5

’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 basics6

’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’


Art the basics

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


Art the basics

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


Estimated number of people on art has more than doubled in south east asia 2003 2005

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)


Art the basics

Unmet need

> 400 000

100 000-400 000

< 100 000

20 high-burden countries represent 85% of global unmet need.


Treatment vs prevention

‘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?


Art the basics

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


Art the basics

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


Art the basics

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


Arvs regulatory and licensing issues

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 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


Art the basics

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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