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Validating clinical and immunological definitions of antiretroviral treatment failure in Malawi
Presented by Mina Hosseinipour, Malawi.
Hosseinipour M.1, van Oosterhout J.2, Weigel R.3, Mzigangira D.1, Saukila N.1, Mhango B.2, Phiri R.2, Phiri S.3, Kumwenda J.2, SAFEST 2 study Team
1UNC Project, Lilongwe, Malawi, 2Malawi College of Medicine, Blantyre, Malawi, 3Lighthouse Clinic, Lilongwe, Malawi
Objectives: Malawi has scaled up a large national ART program using first line therapy (D4T/3TC/NVP). Patients who have been adherent on treatment for at least 6 months and present with a new WHO stage 4 condition (clinical failure) or a > 30% decline from peak CD4 count (immunological failure) are described as having failed ART in the Malawi National ART guidelines. Second line treatment (AZT/3TC/tenofovir/lopinavir/ritonavir) is limited to the Lighthouse Clinic in Lilongwe and the Queen Elizabeth Central Hospital ART Clinic in Blantyre. We evaluated the current national definition of treatment failure in Malawi.
Methods: Patients meeting the Malawi national ART definition for treatment failure from December 2005 to January 2007 were evaluated. Blood was drawn for HIVRNA. Treatment failure was confirmed if HIV-RNA was > 400 copies/ml.
Results: 129 patients were identified as failures (93% Immunological, 7% Clinical) by the national definition. Mean age was 40 years, 52% were female, mean CD4 was 181 cells/ml and mean duration on therapy was 27 months. Seventy-one patients (55%) were confirmed to have virological failure (Clinical 57% and Immunological 48%). Confirmed virological failures were on ART longer (31months vs. 23 months, p=0.0064) and had lower CD4 counts (111 cells vs. 249 cells, p<0.0001). On multivariate analysis, confirmed failure was associated with ART >3 years (OR= 5.84 [1.75-19.5]) and CD4 <200 cells/ml (OR 7.78 [2.49-24.2]). Active Tuberculosis and chemotherapy for Kaposi’s Sarcoma were identified as reasons for CD4 decline with HIVRNA<400 copies and misclassification of immunological failure.
Conclusions: Both immunological and clinical failure definitions misidentify patients as failures in approximately 50% of cases. Although ART failure definitions may be improved by including the duration of ART and the absolute CD4 count at the time of suspected failure, directed confirmatory HIVRNA testing can prevent misclassification of failure in resource poor settings.
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