Abstract #315  -  Clinical, Immunological and Virological Outcomes of Toxicity Patients Initiating Second line Treatment in Malawi
Authors:   Presenting Author:   Mr Dalitso Mzinganjira - University of North Carolina Project
Additional Authors:  Professor JJ Van Oosterhout, Dr J Kumwenda, Dr C Kanyama, Dr R Weigel, Mr  B Mhango, Dr S Phiri, Professor M Hosseinipour, Ms L Brown,
Aim: Background: Over 150, 000 patients have been initiated on the first line Anti-retroviral Therapy (ART) regimen of d4T/3TC/nevirapine in Malawi. The national program offers first-line substitutions in case of toxicity; however some patients experience intolerance to multiple agents and require regimens based on non-standard combinations of available drugs in the ART program. Objective: To determine the outcomes of patients taking toxicity driven non-standard combination ART. Methods: Patients experiencing multiple toxicities to first-line ART drugs in 2 large urban ART clinics were initiated on specialist defined ART regimens. Clients were seen monthly and CD4, HIV1-RNA, and safety laboratories were performed quarterly and as needed. Results: 35 patients with complex toxicity patterns had specialist review. Primary toxicities included lactic acidosis (n=13), severe rash (n=11), severe neuropathy (n=7), hepatitis (n=3) and anemia (n=3). 34 patients initiated the following drug combinations: NRTI/PI (63%), NNRTI/PI (16%), NNRTI/NRTI/PI (19%), NRTI/NNRTI (3%) and were followed for 1 year. One died before ART initiation. Baseline characteristics of the cohort were: 36% male and median CD4, 161 cells/mm3. After 12 months, one death and 3 losses to follow-up had occurred. Among survivors, the proportions with HIV1-RNA <400 copies/ml at 6 and 12 months were 72.4% and 82.1%, respectively, and the median CD4 increases were 69 and 79 cells/mm3. Grade 3/4 toxicities were anemia (n=1) and neutropenia (n=2). 8 patients developed 9 new HIV associated conditions during follow-up: pneumonia (n=5), Kaposi’s sarcoma (n=1), oral candidiasis (n=2), and cryptococcal meningitis (n=1). Recommendations: Non-standard, primarily PI based regimens for toxicity may be piloted with less intensive monitoring. This contrasts our experience with PI-based regimens after ART failure, when severe adverse events were frequent
Discussion:
Go Back