Evaluation of Glycated Haemoglobin (HbA1c) Level in Type 2 Diabetic Chronic HCV Non-cirrhotic Treatment-Naïve Egyptian Patients Eradicated with Sofosbuvir Plus Daclatasvir

Abstract

Background /Introduction: A high prevalence of type 2 diabetes mellitus (T2DM) was seen in association with hepatitis C virus infection; moreover, risk of development of T2DM is increased about 11 folds in patients with risk factors for metabolic syndrome in the presence of chronic hepatitis C virus (HCV) infection. There is a few available data on the effect of HCV eradication by the new direct-acting antiviral drugs (DAAs) on the glycemic control; hence the aim of our study is to evaluate the glycated haemoglobin (HbA1c) level changes in type 2 diabetic chronic HCV non cirrhotic treatment-naïve Egyptian patients after eradication with sofosbuvir (SOV) plus daclatasvir (DCV).

Patients and methods: A prospective observational cross-sectional study, included 128 type 2 diabetic HCV patients with easy to treat criteria (non cirrhotic treatment-naïve patients with the following liver biochemical markers; total serum bilirubin ≤ 1.2 mg/dl, serum albumin ≥ 3.5 g/dl, INR≤ 1.2 and Platelet count≥ 150.000/mm3); according to the protocol of the Egyptian National Committee for Controlling HCV and the guidelines of the European Association for the Study of the Liver. HbA1c was done for all patients enrolled in the study before starting antiviral treatment, at the end of treatment and 3 months (12 weeks) after the end of treatment to patients who achieved sustained virological response (SVR) 12 only.

Results: According to their antidiabetic medications, patients were classified to Group I: 70 patients taking oral hypoglycemic drugs, Group II: 58 patients taking insulin therapy +/- oral hypoglycemic drugs. Regarding the glycemic profile, a statistically significant decrease of mean HbA1c % values was found in the studied patients (n=128), over the period of the study with p-value < 0.05. For better evaluation of improvement of glycemic control, we used a composite endpoint given by the reduction of HbA1c % (of a minimum of 0.5%). The endpoint was reached to 79% (101 patients) of all studied patients 3 months after the end of treatment. 75.7% (53 patients) reached the endpoint in group I, while 82.75 % (48 patients) of group II reached the endpoint 3 months after the end of treatment.

Conclusion: This study supports the idea that HCV eradication leads to a reduction in HbA1c in patients with diabetes, which could delay the onset and progression of microvascular diabetes complications.

Keywords: HCV; diabetes mellitus; direct-acting antiviral drugs; glycated hemoglobin; non cirrhotic; sustained virological response..