Among South Africans with HIV/TB coinfection, antiretroviral changes were rare during TB therapy when the initial regimen was efavirenz plus lamivudine and didanosine, according to analysis of 501 people in the SAPiT trial.
SAPiT randomized ambulatory HIV/TB-coinfected people in South Africa to start antiretroviral therapy (ART) within 4 weeks of TB therapy, to start ART during the first 4 weeks of the continuation phase of TB therapy, or to start ART after TB therapy stopped (Abdool Karim SS, et al. New England Journal of Medicine. 2011; 365: 1492-1501, link below). Early ART in people with a CD4 count below 50 cells/µL improved AIDS-free survival.
In a new analysis, SAPiT researchers assessed individual antiretroviral changes due to toxicity (grade 3 or 4 adverse events) or whole-regimen changes due to virologic failure (viral load above 1000 copies/mL on two occasions 4 weeks apart). The analysis involved 501 people, all of them taking efavirenz, lamivudine, and didanosine with TB therapy.
After a median follow-up of 16 months (95% confidence interval 15.5 to 16.6), 14 people (2.8%) switched individual antiretrovirals because of toxicity for an incidence of 2.1 per 100 person-years, while 25 people (5%) switched entire regimens because of virologic failure for an incidence of 3.7 per 100 person-years.
The most frequent toxicities responsible for switching antiretrovirals were neuropsychiatric effects in 4 people (0.8%), elevated transaminase or lactate levels in 3 (0.6%), and peripheral neuropathy in 2 (0.4%).
Complete regimen changes proved more common in people with an initial CD4 count below 50 cells/µL (P < 0.001) and in those with a body mass index above 25 kg/m(2) (P = 0.01) at study entry.
“Both drug switches and complete regimen change were uncommon in patients cotreated for TB-HIV with the chosen regimen,” the SAPiT team concludes. They advise that “patients with severe immunosuppression need to be monitored carefully, as they were most at risk for treatment failure requiring regimen change.”
Source: Anushka Naidoo, Kogieleum Naidoo, Nonhlanhla Yende-Zuma, Tanuja N. Gengiah, Nesri Padayatchi, Andrew L. Gray, Sheila Bamber, Gonasagrie Nair, Salim S. Abdool Karim. Changes to antiretroviral drug regimens during integrated TB–HIV treatment: results of the SAPiT trial. Antiviral Therapy. 2014; 19: 161-169.
For the study abstract
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For main SAPiT Trial results
Source: IAS