Egypt HCV trial: antivirals plus lifestyle changes or metformin lowered steatosis in 148 patients
In a randomized study of 150 HCV patients with prediabetes, adding lifestyle changes or metformin to antivirals improved glycemic control and steatosis versus antivirals alone.
Researchers in Egypt compared three treatment strategies in 150 patients with chronic hepatitis C virus (HCV) infection, prediabetes and hepatic steatosis, according to a paper in the Egyptian Liver Journal. biomedcentral.com
Egyptian Liver Journalbiomedcentral.comOpen source ↗ The trial was run at the Kasr Al-Ainy Center for treatment of Viral Hepatitis at Cairo University Hospital. Prediabetes was defined as glycosylated hemoglobin (HbA1c) of 5.7–6.4%, and steatosis was measured by controlled attenuation parameter (CAP).
Study design and groups
Patients were randomly divided into three groups. Group 1 received direct-acting antivirals (DAAs) only, group 2 received DAAs combined with lifestyle modifications, and group 3 received DAAs with metformin. The antiviral regimen was sofosbuvir with daclatasvir, with or without ribavirin, for three months. Lifestyle modifications combined a Mediterranean diet with aerobic exercise, and metformin was given at 1000 milligrams daily.
Liver steatosis was assessed at baseline and at sustained virological response 12 weeks after therapy (SVR12), together with body mass index (BMI) and glycemic parameters. Across the cohort, mean age was 49.0 ± 11.42 years, mean BMI was 33.12 ± 4.47 kg/m², mean CAP was 290.11 ± 42.08 dB/m and mean HbA1c was 5.92 ± 0.20%. At baseline the groups did not differ in demographic, laboratory or steatosis characteristics.
Results at SVR12
Of 150 patients, 148 completed the study and achieved SVR12; two patients in group 1 were excluded for non-compliance. biomedcentral.com
Egyptian Liver Journalbiomedcentral.comOpen source ↗ Glycemic parameters improved significantly in all three groups. Steatosis decreased significantly only in group 2 (p < 0.001) and group 3 (p = 0.014).
The change in CAP, BMI, HbA1c and fasting blood sugar differed significantly among the groups (p = 0.004, p < 0.001, p = 0.007 and p = 0.006, respectively). Pairwise comparison showed that groups 2 and 3 were superior in improving glycemic state, while the improvement in liver steatosis was greatest in group 2.
The authors concluded that combining DAAs with lifestyle modifications or metformin in HCV-infected patients with prediabetes and hepatic steatosis improved glycemic control and steatosis more than DAAs alone.
