At 24 weeks, the percentage of patients deemed to have virologic success, defined as HIV-1 RNA less than 50 copies/mL, was 81% in the dolutegravir arm and 89% in the efavirenz arm. The respective rates of virologic nonresponse were 10% and 7%. No virologic data were available because of treatment discontinuations or missing information for 9% and 5% of patients, respectively.
The difference in response rates between the arms was due to non–treatment associated withdrawals among patients on dolutegravir, Dr. Dooley said.
Virologic withdrawals for confirmed plasma HIV-1 RNA of 400 copies/mL or more at or after week 24 for two consecutive tests occurred in one patient on dolutegravir and in none on efavirenz. There were no treatment-emergent resistance-associated mutations to any anti-HIV drugs in the dolutegravir group (data not available for the efavirenz group).
Two patients, both in the efavirenz arm, discontinued therapy because of adverse events. TB-associated rates of the immune reconstitution inflammatory syndrome (IRIS) occurred in 4% of patients in each treatment arm. No patients discontinued therapy because of IRIS or liver-related adverse events.
“We think that this study provides evidence that dolutegravir is effective and well tolerated in adults with HIV/TB coinfection who are receiving rifampin-based tuberculosis therapy, and we hope that this will increase the number of options for TB/HIV coinfected patients for whom there are relatively few treatment possibilities,” she concluded.
Dr. Dooley reported research support via her university from ViiV Healthcare, which funded the study.
SOURCE: Dooley K et al. Abstract 33.