Starting HIV treatment at a CD4 cell count above 500 reduced the risk of tuberculosis, other serious illnesses and death by 44% when compared to starting treatment according to World Health Organization (WHO) guidelines.
The Temprano study, conducted over seven years in Ivory Coast, was designed to test the safety and efficacy of early treatment initiation compared to standard treatment initiation in a lower-income setting with a high prevalence of tuberculosis and bacterial infections. There may be particular benefits to starting HIV treatment early in settings where such infections cause substantial ill health in people living with HIV.
Just over 2000 previously untreated people with HIV (median CD4 count 465 cells/mm3) and without active tuberculosis took part in the study in this West African country. They were randomised to either receive immediate antiretroviral therapy or to begin therapy in line with the WHO guidelines that were current at the time. WHO’s recommendation was for treatment below 200 cells/mm3 when the study began but had shifted to below 500 cells/mm3 by its end.
The primary study endpoint was a composite of any AIDS-defining event, severe bacterial disease, a non-AIDS cancer or death from any cause. These events occurred at a rate of 4.9 events per 100 person-years in individuals randomised to follow WHO guidelines, compared to 2.8 events per 100 person-years in individuals receiving immediate treatment. This amounts to a 44% reduction in the risk of these events.
The most frequent events were tuberculosis and bacterial infections. As in the HPTN 052 study, early treatment was especially effective in reducing the incidence of disseminated (rather than pulmonary) tuberculosis.
In long-term follow up, drug side-effects did not cause significant problems for people starting treatment early.
Temprano also evaluated the benefit of a six-month course of isoniazid preventive treatment (IPT) against tuberculosis, with individuals in both arms also randomised to receive IPT or not. Those who did had a 35% reduced risk of any serious event.
The results lend support to the view that CD4 criteria for starting treatment should be dropped, so that individuals start treatment whenever they are ready to start – at least in lower-income settings where tuberculosis and bacterial infections are major causes of illness in people living with HIV.
Within the next two years, the START study of early treatment initiation will provide information about the risks and benefits of early treatment in developed world settings.Source: www.aidsmap.com