Challenges in the management of treatment-experienced patients in Sub- Saharan Africa: Clinical Perspective

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1 Challenges in the management of treatment-experienced patients in Sub- Saharan Africa: Clinical Perspective Dr. Patricia Aladi Agaba Senior Lecturer, Department of Family Medicine, University of Jos Honorary Consultant Family Physician, Department of Family Medicine, Jos University Teaching Hospital

2 Introduction Since 2001, the international effort to scale up antiretroviral therapy (ART) in the developing world has been one of the most important programs in global health Initially, there was considerable reluctance to provide ART in developing countries, due to concerns that treatment was too expensive, too complex, and that drug resistance would be promoted by inadequate programs

3 Number of people receiving ART in LMIC by region, GLOBAL HIV/AIDS RESPONSE Progress Report 2011

4 Characteristics of responding countries, people and regimens in groups A and B Group A Group B Group A: 45 LMIC excluding the Region of the Americas) Group B : 21 LMIC from the Region of the Americas GLOBAL HIV/AIDS RESPONSE Progress Report 2011

5 WHY ARE WE MISSING TREATMENT FAILURE?

6 WHO criteria to diagnose failure Clinical Immunological Clinical Immunological Virological* > copies Clinical Immunological Virological** > copies * Based on clinical and immunological criteria to confirm failure (optional) ** Same as 2006 but strongly recommended if possible (no routine VL)

7 Use of laboratory services for monitoring ART In a WHO survey, 66 LMIC, with people receiving ART as of December 2010, provided data on the availability of selected laboratory services. Laboratory capacity for CD4 count tests was considerably greater than that for quantifying viral load. Among reporting countries, 2155 facilities were equipped to perform CD4 count tests, whereas only 394 facilities had the necessary infrastructure for measuring viral load. Twelve countries reported having no viral load capacity. GLOBAL HIV/AIDS RESPONSE Progress Report 2011

8 Virologic failure and switch to 2 nd line Boulle et al. AIDS. 2010

9 Virologic failure predates immunologic failure! Rawizza H et al, CID 2011

10 Immunologic vs. Virologic failure Country (Ref) Sample size /Follow-up Sensitivity Specificity South Africa (Mee et al, AIDS 2008) Uganda (Reynolds et al, AIDS 2009) months 21.2% 95.8% months 23.0% 90.0% Nigeria (Rawizza et al, CID 2011) months 53.9% 76.1%

11 Prices for first, second and third line in July 2010 Prices for first, second and third line ART July MSF, untangling the web of price reductions, 14th edition, July 2011

12 CONSEQUENCES OF LATE SWITCH

13 Late First line failure in Mali and Burkina Faso Sylla and al., Antivir Ther % of TAMs: the use of other NRTIs is not possible for most of these patients

14 Resistance mutations in 2 nd line failures in Mali Percentage (%) ABC AZT ddi FTC/3TC d4t TDF NVP EFV ETR SQV IDV LPV DRV NFV TPV ATV FAPV Antiretroviral Drugs The prevalence of different antiretroviral is in blue and only the prevalence of antiretroviral drug relay for to 2 nd and 3 rd line are in red Maiga AM et al, AB WEAA0301, ICASA 2011

15 Adverse clinical events begin to occur early Parjuades-Rodriguez M et al, JAMA 2010

16 10% mortality in the first year following switch to 2 nd line Hosseinipour M, HIV Med 2010

17 WHAT WE NEED

18 Clear guidelines WHO 2010 treatment guidelines for adults and adolescents

19 Nigerian 3 rd line recommendations Refers to treatment given after 2 nd line therapy failure The choice of salvage therapy is more difficult in the absence of resistance testing The recommendation is that the switch to salvage therapy be left in the hands of highly qualified HIV specialists with requisite experience and expertise in the management of advanced and complicated HIV disease Nigerian National guidelines for the treatment of HIV/AIDS in adults and adolescents, October 2010

20 Laboratory services are crucial in HIV treatment programs Peter TF et al, Am J Clin Path 2010

21 Point of care needed for VL and resistance testing Calmy M at al CID 2007

22 Cumulative mortality of patients starting ARV with or without routine VL * Keiser O et al, AIDS 2011 * Four sites with routine VL monitoring from the Republic of South Africa and 2 sites without access to routine VL monitoring in Malawi and Zambia

23 Human resource for HIV/AIDS services overstretched!

24 Adequate staffing of Treatment programs A 25% increase in HRHA inflow increases the population ART coverage by 10% 21% (17% in SSA, 10% in NSSA, 21% in SA) Bärnighausen et al, AIDS pt Care STD, 2007

25 Conclusion National programs must provide more robust firstline regimens National treatment protocols need to be revised to recommend best practices based on evidence Donors must make it clear that they will support countries who make this change with necessary financing.

26 Conclusion There must be increased access to viral load testing, with progressive introduction of viral load monitoring to support the public health approach to antiretroviral treatment provision Countries must begin ensuring access to second and third-line treatment combinations Originator companies need to carry out speedy registration of new drugs in developing countries