1. Charles Gilks HIV Department, WHO
GUIDELINES FOR A PUBLIC HEALTH APPROACH TO ARV THERAPY IN RESSOURCE LIMITED SETTINGS
Charles Gilks
HIV Department, WHO

3. Development of WHO HIV treatment guidelines
May 2001: WHO consultation involving 100 experts from 23 countries recommend the development of a public health approach to ARV therapy, with simplified regimens and monitoring to enable scale up of ARV access, and call for an ad hoc working group
Nov 2001: WHO working group brings together 120 experts from developing and industrialised countries and develops recommendations for first and second line regimens and minimum monitoring standards
February 2001: draft report written by writing committee circulated
April 2001: a 23 member writing committee finalises and approves document and charges chair of the writing committee and secretariat to produce executive summary and integrate references
A fully referenced draft is available (245 references) and executive summary has been published in 6 languages by WHO

4. A Public Health approach
Able to scale up ART to meet the needs of people living with HIV/AIDS in resource-limited settings
standardization and simplification of ARV regimes to support broad and efficient implementation, and accessible treatment programmes
evidence-based recommendations aiming to avoid substandard or sub-optimal treatment or the creation of the potential for the emergence of drug resistant virus

5. Audience for Guidelines
Primary audience for a Public Health Approach:
Treatment Advisory Boards
National AIDS Programme Managers
Other senior level policymakers planning ART implementation
Whilst it is hoped that the document will be of use to clinicians in resource-poor settings it is not intended to be a clinical manual to guide patient management

6. Underlying considerations
Potent regimens (including at least 3 drugs) to prevent resistance and maximize benefit
Standardization to allow use in settings where HIV/AIDS specialists and tests to monitor treatment are not readily available and facilitate continuous availability of the drugs
Recommendations on best available evidence
Incorporate flexibility in regimens to manage toxicity
Include specific groups - children, pregnancy, IDUs and co-pathology
aim for standard first then second-line regimes

7. When to start therapy

8. First line regimens

9. Second line regimens

10. Entry and Monitoring
Must have: clinical assessment, HIV testing, and haemoglobin t
Additional basic testing: white blood cell count and differential, LFTs, creatinine and/or blood urea nitrogen, serum glucose, and pregnancy tests for women.
Desirable tests include bilirubin, amylase and serum lipids.
CD4 cell determinations are very desirable and every effort should be made to make these widely available.
Viral load testing is currently considered optional.
Increasing recognition that access to laboratory monitoring will be a major access bottleneck

11. Target for ARV treatment
3 million on ART by 2005
by 2007, 45% requiring ART receive it (CMH)
40 million PWHAs in resource-limited setting
15% clinically sick enough to need ART
Aspirational goal; without capacity development
particularly human resources we will fail

12. ART in HIV-positive patient with TB
Not ideal to prescribe seven potentially toxic drugs together
Many will be diagnosed with HIV when present with TB
Recommend that TB patients complete Tb therapy unless a high risk of HIV progression/death (CD4; dissemination)
Try to complete induction treatment if possible without starting ARVs
If clinically necessary treat both diseases together

13. ART in HIV-positive patient with TB
CD4 below 50 and/or disseminated TB
dual treatment indicated
ZDV/3TC backbone; ABC or EFV or SQV/r preferred;
CD4 between or TLC <
complete 2 months of induction therapy
same regime considerations
Pulmonary TB and CD4 > 200 or TLC >
Treat TB
Monitor clinical status; start ARV if necessary
Start “standard” ART after therapy when indicated

14. ART in HIV-positive patients with TB
Almost a data free-zone …
need to review evidence and experience of first wave of TB-HIV treatment centres ASAP
revise guidelines accordingly
“In this rapidly evolving field, WHO recognises that these recommendations will need to be updated on a regular basis”