Phase III INSPIRING interim analysis shows Tivicay effective and well tolerated in HIV patients with tuberculosis.- Viiv HealthCare.

ViiV Healthcare announced interim (Week 24) study results from INSPIRING, a phase IIIb study evaluating the safety and efficacy of Tivicay (dolutegravir) in antiretroviral treatment-naive (ART-na�ve) adults with HIV, co-infected with tuberculosis (TB). Results show that dolutegravir when administered at 50mg twice-daily with dual nucleoside reverse transcriptase inhibitors (NRTI), was effective and well-tolerated in HIV/TB co-infected adults receiving rifampin-based TB therapy.

An interim analysis conducted at 24 weeks showed that the proportion of patients who maintained viral suppression (HIV-1 RNA less than 50 copies per ml) in the dolutegravir arm was 56/69 (81%) (95% confidence interval CI: 72%, 90%). In the efavirenz arm, 39/44 patients (89%) (95% CI: 79%, 98%) maintained viral suppression. No patients in the dolutegravir arm and two patients in the efavirenz arm discontinued due to adverse events, while five participants (7%) in the dolutegravir arm and none in the efavirenz arm discontinued due to non-treatment related reasons (loss to follow-up/protocol deviations).

There were no reports of treatment emergent resistance in the dolutegravir arm and there was one report in the efavirenz arm. TB-associated immune reconstitution inflammatory syndrome (IRIS) rates were low in both arms (dolutegravir, n=4; efavirenz n=4) with no patients discontinuing due to IRIS or liver events. The INSPIRING study is ongoing and 48-week data will be presented at a future scientific meeting. Data were presented at the annual Conference on Retroviruses and Opportunistic Infections.