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

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

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

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

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

When to start therapy

First line regimens

Second line regimens

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

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

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

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 50 - 200 or TLC < 1000-1200 complete 2 months of induction therapy same regime considerations Pulmonary TB and CD4 > 200 or TLC > 1000-1200 Treat TB Monitor clinical status; start ARV if necessary Start “standard” ART after therapy when indicated

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”