BackgroundMetabolic-associated fatty liver disease (MAFLD) is increasingly common among people living with the human immunodeficiency virus (PLHIV) and can progress to cirrhosis and cirrhotic-related complications. Pioglitazone is known to improve insulin sensitivity that results in decreasing serum fatty acids and resolution of non-alcoholic steatohepatitis. This study was aimed to evaluate the efficacy of pioglitazone for the treatment of MAFLD in PLHIV and prediabetes.
MethodsA randomized controlled trial was conducted in HIV-positive individuals with prediabetes who had evidence of a fatty liver by abdominal ultrasonography or controlled attenuation parameter (CAP) ≥ 238 decibels per meter (dB/m) through using transient elastography. Participants were randomized to take pioglitazone, 30 mg/day, (pioglitazone group) or placebo (control group) and were followed up and assessed for 48 weeks.
ResultsA total of 98 participants were enrolled, 49 in each group. The mean age was 50.8 years and 66.3% were males. All participants had received antiretroviral therapy with undetectable HIV ribonucleic acid (RNA) and the mean CD4 cell count was 463.2 cells/mm 3 . The mean baseline CAP and liver stiffness were 285.7 dB/m and 5.4 kilopascals (kPa), respectively. At 24 weeks, the mean change of the CAP level was -25.7 dB/m in the pioglitazone group and -5.6 dB/m in the control group (p = 0.040); the mean change of liver stiffness was 0.014 kPa in the pioglitazone group and 0.403 kPa in the control group (p = 0.199). At 48 weeks, the mean change of the CAP level was -23.5 dB/m in the pioglitazone group and 10.2 dB/m in the control group (p < 0.001); the mean change of liver stiffness was -0.184 kPa in the pioglitazone group and 0.554 kPa in the control group (p = 0.016). The mean changes of fasting plasma glucose (FPG) at 24 and 48 weeks were -14.9 and -17.5 mg/dL in the pioglitazone group, respectively, and -3.6 and 4.5 mg/dL in the control group, respectively (p < 0.05). The mean change of the body mass index, lipid profiles, and liver enzymes were not different between the two groups at both time points (p > 0.05). No serious adverse effects were observed in either group.
ConclusionsPioglitazone significantly reduces CAP, liver stiffness, and FPG in PLHIV with prediabetes and MAFLD. Further studies with long-term follow-up duration are warranted to determine the role of pioglitazone for clinical use in this population.