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 HIV and Hepatitis.com Coverage of the
5
th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009)
 July 19 - 22, 2009, Cape Town, South Africa
 The material posted on HIV and Hepatitis.com about IAS 2009 is not approved by nor is it a part of IAS 2009.
Impact of Adverse Events on Survival of African HIV Patients in the DART Trial

Due to cost, there is often limited access to laboratory testing in middle- and low-income countries. In these settings, World Health Organization (WHO) stage 3/4 adverse events are used to determine the success or failure of antiretroviral therapy (ART). As reported at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention last week in Cape Town, South Africa, some WHO stage 3 events have a more significant impact on survival than stage 4 events, and further evaluation is needed to determine the effects of switching to second-line therapy after a survival risk event.

The Development of Antiretroviral Therapy in Africa (DART) trial, a randomized comparison of antiretroviral management strategies, was conducted at medical centers in Uganda and Zimbabwe. Participants were symptomatic African adults with CD4 counts < 200 cells/mm3 who had no prior treatment with ART.

Participants initiating combination antiretroviral therapy and were randomly assigned to 2 management strategy arms. In the Laboratory and Clinical Monitoring (LCM) arm, routine CD4 cell tests and hematology and biochemistry monitoring for toxicity were performed every 3 months, with results returned to patients' clinicians. In the Clinically Driven Monitoring (CDM) arm, only grade 4 toxicity results were returned, but tests other than CD4 count could be requested if clinically indicated.

In the present analysis, the researchers aimed to estimate the effect on survival of WHO stage 3/4 events. A total of 3179 participants contributed 11236 years of follow-up data.


Results

A total of 281 deaths occurred during the follow-up period.
518 participants (16%) switched to second-line therapy, and 43 of the deaths occurred while on second-line ART.
Among participants on first-line ART, 123 developed cryptococcosis, 177 had pulmonary tuberculosis, 110 had extrapulmonary tuberculosis, 178 had esophageal candidiasis, and 405 had oral candidiasis.
Among patients on second-line treatment, 6 developed cryptococcosis, 9 developed pulmonary tuberculosis, 8 developed extrapulmonary tuberculosis, 3 had esophageal candidiasis, and 7 had oral candidiasis (59 deaths).
There were 48 deaths due to cryptococcosis, 40 due to pulmonary tuberculosis, 19 due to extrapulmonary tuberculosis, 25 due to esophageal candidiasis, and 59 due to oral candidiasis.
As expected, WHO stage 3/4 events occurred more frequently among participants with lower CD4 counts, lower hemoglobin levels, recent weight loss, and a history of other WHO 3/4 events.
Overall (including patients on both first-line and second-line ART), cryptococcosis increased all-cause mortality risk by 6.01-fold, pulmonary tuberculosis by 2.84-fold, extrapulmonary tuberculosis by 1.61-fold, oral candidiasis by 1.98-fold, and esophageal candidiasis by 0.91-fold.
The risk of death was higher in the 12 weeks following cryptococcosis (25 deaths) than subsequently (23 deaths).
Increased mortality risk in the 12 weeks following an event were also observed for pulmonary tuberculosis, extrapulmonary tuberculosis, and oral candidiasis.

"Mortality rates following a WHO stage 3/4 event vary considerably with diagnosis; of note, some WHO 3 events have greater mortality impact than WHO 4 events," the investigators concluded. "More work is needed to evaluate the impact of switching to second-line therapy following an event on mortality risk."

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Joint Clinical Research Centre, Kampala, Uganda; MRC Clinical Trials Unit, London, UK; University of Zimbabwe, Harare, Zimbabwe; MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda; Infectious Diseases Institute, Makerere University, Mulago, Uganda; Imperial College, London, UK.

7/31/09

Reference
C Kityo, D Ford, AS Walker, and others (on behalf of The DART Trial Team). Effect of WHO stage 3/4 events after ART initiation on survival of HIV-infected African adults in the DART trial. 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009). July 19-22, 2009. Cape Town, South Africa. Abstract MoPeB003.


 

 

 

 

 

 

 

 

 

 

 

 

 

 




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