In Phase 3 clinical studies, patients receiving tesamorelin for injection had an increased risk of developing diabetes (HBA1c level ≥6.5%) at week 26 vs placebo (4.5% vs 1.3%); Hazard ratio: 3.3 (95% CI: 1.4, 9.6).
At 26 weeks
*The safety of EGRIFTA SV® (2 mg/vial formulation) have been established based on clinical trials conducted with EGRIFTA® (1 mg/vial formulation). Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA SV® are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA®.
*The safety of EGRIFTA SV® (2 mg/vial formulation) have been established based on clinical trials conducted with EGRIFTA® (1 mg/vial formulation). Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA SV® are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA®.
At 52 weeks
(During the second 26 weeks of the trial)
Over 52 weeks, responders (≥8% reduction in excess abdominal fat) experienced2:
References: 1. Data on file. Theratechnologies, Inc. 2. Stanley TL, Falutz J, Marsolais C, et al. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012;54(11):1642-1651.