The study included a second randomization at baseline, 906 subjects were randomized to enhanced prophylaxis with isoniazid, fluconazole, azithromycin, trimethoprim-sulfamethoxazole, and single-dose albendazole (Albenza); 899 others were randomized to standard prophylaxis with trimethoprim-sulfamethoxazole alone (N Engl J Med. 2017 Jul 20;377[3]:233-45).
Enhanced prophylaxis nearly halved the incidence of IRIS from 12% to 7.4%, and significantly reduced deaths at 48 weeks from 14.4% to 11% (P = .04).
“Patients with very low CD4 counts and high viral loads are the patients where this enhanced protocol package would be useful,” Dr. Gibb said.
The median age in the trial was 36 years; 4% of the subjects were 5-17 years old. Just over half the subjects were male.
The work was supported by the U.K. Department for International Development, the Wellcome Trust, and others. Dr. Gibb didn’t have any disclosures.
aotto@frontlinemedcom.com
SOURCE: Gibb D et al. CROI, Abstract 23.