Camel milk with pegylated interferon alfa-2a and ribavirin for treatment-naive chronic hepatitis C genotype 2 3 : an open-label randomized controlled trial

الملخص EN

Background: Chronic hepatitis C is one of the most important causes of cirrhosis and hepatocellular carcinoma (HCC).

Camel milk (CM) is a new candidate therapy for chronic hepatitis C (CHC).

Objectives: The present study assessed the safety and efficacy of pegylated interferon alfa-2a and ribavirin with CM (CM + Peg IFN/RBV) and without CM (Peg IFN/RBV) in CHC genotype 2/3 infections.

Methods: This study was an open-label, randomized, phase 2 trial.

Sampling strategy and date was computer–generated randomization.

The researchers randomly selected 45 adult patients (ages > 18 years), who were treatment-naive with CHC infection (noncirrhotic) to receive Peg IFN/RBV with standard-dose alone (group A, n = 23), CM+ Peg IFN/RBV: 500 cc orally per day (group B, n = 22) for 24 weeks in Iran.

The primary efficacy outcomes were early virological response (EVR12) and end-of-treatment response (ETR24), the secondary efficacy outcome was sustained virological response (SVR24), and the safety outcomes were adverse events and laboratory tests at end-treatment to assess.

Results: The EVR12 was 60% (12/20), ETR24 90% (18/20), and SVR24 100% (18/18) of CM + Peg IFN/RBV therapy.

The EVR12 was 15% (3/20), ETR24 70% (14/20), and SVR24 rates were 71% (10/14) in Peg IFN/RBV therapy (P < 0.05).

Rates of discontinuation due to adverse events were 8.6% (2/23) in control and no discontinuation in intervention group.

The most common adverse events were fatigue, anemia, and insomnia.

Conclusions: Combination of CM with Peg IFN/RBV for 48 weeks showed significant improvements in the viral response and decreased adverse effects in CHC genotype 2/3 (P < 0.05).

The data of the study supported the CM synergistic antiviral activity of Peg IFN/RBV.

Large clinical trials are needed to confirm the results.