[1213] PRELIMINARY ANALYSIS OF TOXICITY AND TOLERABILITY AMONG THE FIRST ARV-TREATMENT NAÏVE HIV-1C-INFECTED PERSONS OF THE BOTSWANA NATIONAL ARV TREATMENT PROGRAM

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] PRELIMINARY ANALYSIS OF TOXICITY AND TOLERABILITY AMONG THE FIRST ARV-TREATMENT NAÏVE HIV-1C-INFECTED PERSONS OF THE BOTSWANA NATIONAL ARV TREATMENT PROGRAM

[AUTHOR(S):] W Wester³, N Ndwapi¹, H Bussmann³, O Johnson¹, T Gaolathe¹, A Mujugira¹, A Avalos³, H Moffat¹, T Peter³, M Essex^3,4 and R Marlink^3,4
¹Infectious Disease Care Clinic, Princess Marina Hospital, Gaborone, Botswana; ²University of Pennsylvania, USA; ³Botswana-Harvard Partnership for HIV Research and Education; and ⁴Harvard School of Public Health, Department of Immunology and Infectious Disease, Boston, MA, USA

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 1213
Antiviral Therapy 2003; 8(Suppl. 1):S528

[ABSTRACT:] 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 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 years (range 21–64 years); 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 anaemia 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 CBVbased therapy developed anaemia – grade 3/4 (Hbg <6.9) with a total of four deaths (mean time to toxicity 11.6 weeks); 3.42% on NVPbased therapy developed severe rash – grade 3/4 (mean time to toxicity 28 days); 2.7% developed NVP-related hepatitis (grade 3/4) with two 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-1Cinfected individuals. The rates and time to toxicities are similar to those reported among HIV-1B-infected patients on HAART. More frequent laboratory monitoring of haemoglobin per the Botswana national treatment guidelines for patients on AZT-containing regimens, for the early detection of AZT-induced anaemia, may prove beneficial. Additional research evaluating the cost-utility of the laboratory monitoring protocols recommended for toxicity screening is ongoing.

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