Efficacy and safety of tesamorelin in people with HIV on integrase inhibitors.

Randomized double-blind placebo-controlled trial

“We leveraged a randomized double-blind trial of 61 PWH and metabolic dysfunction-associated steatotic liver disease to evaluate the efficacy and safety of tesamorelin 2 mg once daily versus identical placebo among participants on INSTI-based regimens at baseline.”

People with HIV on INSTI-based regimens with metabolic dysfunction-associated steatotic liver disease

“In the parent trial, we enrolled 61 men and women aged 18-70 years who had documented HIV infection on stable ART for ≥3 months with a CD4+ T cell count >100/μL and HIV viral load <400 copies/mL.”

38 participants on INSTI-based regimens at baseline

“Of 61 participants in the parent clinical trial, 38 participants (20 randomized to tesamorelin, 18 randomized to placebo) were on an INSTI-based regimen at baseline (Supplemental Figure 1).”

12 months

“Among 38 participants on INSTIs at baseline, 15 participants on tesamorelin and 16 participants on placebo completed the 12-month double-blind phase of the study (Supplemental Figure 1).”

Tesamorelin led to significant declines in visceral fat compared to placebo

“Tesamorelin led to significant declines in visceral fat (median [interquartile range], −25 [−93, −2] vs. 14 [3, 41] cm2, P=0.001) and hepatic fat (−4.2% [−12.3%, −2.7%] vs. −0.5% [−3.9%, 2.7%], P=0.01) as compared to placebo (Figure 1, Supplemental Table 1).”

Tesamorelin reduced the trunk-to-appendicular fat ratio compared to placebo

“Concordant with a selective reduction in visceral but not subcutaneous fat, tesamorelin also reduced trunk-to-appendicular fat ratio (−0.1 [−0.3, 0.0] vs. 0.0 [−0.1, 0.1], P=0.03).”

Tesamorelin was well-tolerated with similar adverse event frequency to placebo

“Tesamorelin was well-tolerated with a similar frequency of adverse events, including hyperglycemia, between treatment groups (Supplemental Table 2).”

Small sample size and limited generalizability to individuals with longer-term exposure to contemporary INSTIs

“Our sample size was relatively small, and thus we did not have adequate power to analyze effects of tesamorelin in the context of specific INSTI-based regimens.”