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Infants in southern Africa start antiretroviral therapy late with advanced disease
Lesley Odendal, 2014-10-21 08:50:00
Three quarters of infants starting antiretroviral therapy (ART) across eleven clinics in southern Africa had severe HIV disease and 87.2% met the 2006 World Health Organization (WHO) definition of severe immunosuppression, according to a study presented at the 2014 Southern African HIV Clinicians Society conference in Cape Town, South Africa, last month.
There was a modest improvement in the proportion of infants who started treatment before the onset of severe immunosuppression or severe HIV-related illnesses after 2009, but the majority of infants starting treatment in 2012 had stage 3 or 4 HIV disease.
The study described the outcomes of infants starting ART at eleven clinics in Malawi, South Africa, Zambia and Zimbabwe. The study included data on 4945 infants who had not previously taken ART (treatment naive), aged less than 12 months, who started more than three antiretroviral drugs after 2003. Infants were followed up for a median time of 11.2 months (IQR: 2.8-20 months). The data were collected by sites contributing to the International Epidemiologic Database to Evaluate AIDS in Southern African (IeDEA-SA).
There is limited evidence regarding the outcomes for infants starting ART in routine care settings of southern Africa. Infants with HIV are a high-risk population as it is estimated that without ART provision, up to 30% of HIV-positive infants will die before reaching one year of age and 50% by two years of age. In 2010, WHO introduced infant ART guidelines which recommended that all children under the age of 24 months should be initiated on ART immediately after diagnosis with HIV.
The overall median age at ART initiation was 5.9 months with a median CD4 percentage of 18.5%. More than half (57.9%) of the infants had been exposed to prevention of mother-to-child transmission (PMTCT) measures.
Initiation of treatment after 2009 was associated with lower mortality, with an adjusted hazard ratio of 0.75 (95% CI: 0.59-0.94) and was the only predictor of virological suppression. There was a notable improvement from the start of 2010 both in baseline characteristics at ART initiation and the associated outcomes. The median age at ART initiation declined from 6.1 months to 5.4 months (p = 0.00), when comparing the 2004 to 2009 and the 2010 to 2012 cohorts. This correlated with an improvement in other baseline characteristics of the two cohorts, namely the proportion of those with WHO stage 3 or 4 disease was 81.2% compared to 63.4% (p = 0.00) and 89.2% of participants had severe immune suppression between 2004 and 2009 compared to 81.3% (p = 0.00) in the 2010 to 2012 cohort. The median CD4 percentage also rose from 18 to 20.7% (p = 0.00) between the two groups.
“This suggests that the introduction of the WHO 2010 guidelines for initiating pediatrics did lead to prompter ART initiation with improved outcomes beyond an improvement in baseline disease characteristics,” said Dr Mireille Porter, the presenter of the study.
Overall, the probability of virological suppression at six and twelve months was 21% and 41% respectively. Loss to follow-up (LTFU), defined as no visit for more than nine months prior to site database closure, was 29%.
Mortality was twice as high in infants with severe immunosuppression (aHR: 2.19; 95% CI: 1.44-3.35), 1.36 times higher in those with WHO stage 3 or 4 disease (aHR: 1.36; 95% CI: 1.04 -1.78) and anaemia and lower weight-for-age z-score were also associated with higher mortality.
According to the survival analysis, 39.4% of infants would be alive and in care at 36 months, 13.01% would have died, 24.48% transferred out, with a loss to follow-up of 23.23%.
“The proportion of infants initiating ART with baseline disease severity, the high probability of mortality and the high loss to follow-up is a concern. However, the majority of those remaining in care had good virological responses on ART,” said Dr Porter.
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