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Preliminary Analysis of Toxicity & Tolerability Among the First ARV-Treatment Naive HIV-1C Infected Persons in the Public Sector at Princess Marina Hospital William Wester 1, Ndwapi Ndwapi 2, Hermann Bussmann1, Oni Johnson1, Tendani Gaolathe 2, Andrew Mujugira 2, Ava Avalos1 , Howard Moffat 1, Trevor Peter 1, Patson Mazonde 3, Ernest Darkoh 3, Max Essex 1,3 and Richard Marlink 1,3 1Botswana-Harvard Partnership for HIV Research and Education, Gaborone, Botswana, 2 Infectious Disease Care Clinic; Princess Marina Hospital, Gaborone, Botswana, 3Botswana Ministry of Health, Gaborone, Botswana, 4Harvard School of Public Health, Department of Immunology and Infectious Disease, Boston, Massachusetts Background: The Botswana adult national ARV treatment guidelines for the initiation of HAART include presence of an AIDS-defining illness and/or a CD4 cell count less than or equal to 200 cells/mm3. A large percentage of patients who qualify for treatment under these guidelines present with advanced disease which may lead to higher rates of treatment-modifying toxicities. We describe the toxicity and tolerability profile of the first 306 patients initiated on HAART as part of one site within the Botswana national ARV treatment program. Methods: Preliminary results from a retrospective analysis of the first 306 patients initiated on ARV treatment as part of the Botswana National Program who registered from January 21,2002 through June 10, 2002 with an average of 9 months follow-up ending February 28, 2003. Toxicity grading scale reflects DAIDS guidelines. Results: Baseline Characteristics: Age 36.8 yrs (range 21-64 yrs); females 56%, males 44%; Mean CD4 value 81 cells/ml; Mean viral load 442,000 copies/ml; 19.9% Hepatitis B surface Antigen positive; 14% Pre-existing anemia grade 2/3; 27% Peripheral neuropathy grade 1/2. Treatment Regimens: 137 CBV/NVP and 151 CBV/EFV with the remaining patients placed on other PI-sparing HAART regimens. Toxicity rates: 7.98% on CBV-based therapy developed anemia - grade 3/4 (Hbg <6.9) with a total of 4 deaths (mean time to toxicity 11.6 weeks); 3.42% on NVP-based therapy developed severe rash - grade 3/4 (mean time to toxicity 28 days); 2.7% developed NVP-related hepatitis (grade 3/4) with 2 deaths (mean time to toxicity 12.6 weeks) 8.3% developed pancreatitis on DDI/D4T-based therapy (mean time to toxicity -26 days); 4.45% developed EFV related CNS complications. Mortality: 10.7% (33/306). Conclusions: HAART is extremely well tolerated among HIV-1C infected individuals. The rates and time to toxicities are similar to those reported among HIV-1B infected patients on HAART. More frequent laboratory monitoring of hemoglobin per the Botswana national treatment guidelines for patients on AZT containing regimens, for the early detection of AZT induced anemia, may prove beneficial. Additional research evaluating the cost-utility of the laboratory monitoring protocols recommended for toxicity screening is ong |