Giving low dose prednisone shortly after the onset of HIV treatment to people who are both infected with tuberculosis and have very low CD4 degrees can prevent their immune system from recovering against TB infection, reports doctors.
Rebound is known as paradoxical tuberculosis-associated immune reconstruction inflammatory syndrome, or IRIS.
In the new clinical trial, the problem occurred in 32.5% of 120 patients receiving prednisone treatment during the first four weeks of antiretroviral treatment for their HIV infection. It affected 46.7% of the 120 who received placebo instead (P = 0.03).
The improvement was seen "without evidence of increased risk of serious infections or cancer," said the team, led by Dr. Graeme Meintjes at the University of Cape Town in South Africa.
Starting antiretroviral therapy for HIV patients with low CD4 values, and doing so within the first two weeks of treatment for TB, saves lives, he told Reuters Health by email.
"But this also comes at the expense of a double higher risk of developing a common inflammatory complication-TB-IRIS. So far, there was no management strategy to prevent this complication. The results of our study provide clinics with a strategy to reduce the risk of this complication. There was a 30% decrease in TB-IRIS in patients receiving prednisone, says Dr. Meintjes.
Five volunteers in the prednisone group died against four who received placebo. The severity of serious infections was lower with prednisone, but not significantly so, occurring in 11 prednisone patients and 18 placebo recipients (P = 0.23).
All patients had CD4s of 100 cells / μL or less. Everyone had begun treatment for their TB within 30 days of starting antiretroviral treatment for their HIV.
In many countries there are people who have HIV because they show symptoms of tuberculosis.
"Although TB-IRIS is a rare cause of death, many patients may develop quite severe symptoms and about a quarter developing TB-IRIS requires hospitalization," says Dr. Meintjes. "The results of our study provide a strategy for clinics to reduce risk."
The study, known as PredART, was done at an HIV-TB clinic in South African town Khayelitsha. Patients with Kaposi sarcoma, rifampin-resistant TB, neurological or pericardial TB or other conditions are excluded.
The total daily dose of prednisone was 40 mg for the first 14 days followed by 20 mg for the next 14 days.
When cases of tuberculosis-associated IRIS occurred, they were treated on an open basis with 1.5 mg prednisone per kg body weight per day.
The trial was not driven to detect a mortality benefit of prednisone treatment.
Dr Meintjes said based on early words of results, "there is now a recommendation for the use of prednisone to prevent TB-IRIS in the European AIDS Clinical Society ART guidelines and CDC Opportunistic Infection guidelines."
"We expect the publication of these results to lead other guidelines committees to adopt this recommendation," he said.
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