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| |  Predictors of Toxicity and Treatment Failure Identified in Co-treatment of Tuberculosis and AIDS: Presented at AIDS 2010 By Jenny Powers VIENNA -- July 26, 2010 -- Several factors have been identified that predict the need for an antiretroviral single drug switch (SDS) and/or a complete regimen change (CRC) because of toxicity or treatment failure in patients co-treated for both HIV and tuberculosis (TB) infections, according to a data analysis presented here at the 18th International AIDS Conference. A 50 cell/mcL CD4 decrease from the baseline count at antiretroviral initiation may be a predictor for toxicity or treatment failure. Furthermore, the presentation of grade 3 or 4 peripheral neuropathy at baseline was associated with an SDS due to toxicity in the central nervous system, according to Anushka Naidoo, Centre for AIDS Programme of Research (CAPRISA) Pharmacy, Durban, South Africa. Naidoo presented these results on July 20 on behalf of a team of investigators that conducted a retrospective study to determine how often an antiretroviral SDS and/or a CRC was made and the reasons for these changes in patients receiving combined antiretroviral and TB treatment. This analysis was performed on data from a randomised trial involving patients coinfected with HIV and TB during the 4-year period from May 2005 to May 2009. Univariate and multivariate regression models were applied to data from 561 patients co-infected with HIV and TB to identify potential predictors for SDS. Patients were followed up for a median of 17 months (interquartile range [IQR]: 13-20 months) following treatment initiation with efavirenz (600 mg), lamivudine (300 mg), and didanosine EC (250 or 400 mg administered once daily) together with standard anti-TB treatment. SDS due to toxicity occurred in 13 (1.8%) patients; the most commonly experienced toxicities resulting in SDS were peripheral neuropathy in 3 (23%) patients and central nervous system/neuropsychiatric toxicity in 3 (23%) patients. These toxicities occurred, on average, 4.6 and 5.9 months into treatment, respectively. Univariate and multivariate analysis found SDS to be significantly associated with 50 cell/mcL CD4 baseline decrease at antiretroviral initiation and/or a grade 3/4 peripheral neuropathy at baseline. CRC was made because of virological failure or lack of reduction of viral load in 22 (3.9%) patients at a median time of 10.4 months (IQR 8-12 months). A 50 cell/mcL CD4 decrease from the baseline count at ARV initiation was associated with treatment failure was demonstrated in the univariate analysis only. While the incidence of an antiretroviral SDS and/or CRC because of toxicity or treatment failure was low in these coinfected patients, the authors support treatment of both TB and HIV in coinfected patients. [Presentation title: Antiretroviral Drug Switches in an Integrated TB and HIV Treatment Trial. Abstract TUPDB306]
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