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

Al-Reza Hosseini, S. M. and Zibaee, S. and Yousefi, M. and Taghipour, A. and Ghanaei, O. and Noras, M. (2017) Camel milk with pegylated interferon Alfa-2a and ribavirin for treatment-naive chronic hepatitis C genotype 2/ 3: An open-label, randomized controlled trial. Iranian Red Crescent Medical Journal, 19 (9).

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Abstract

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. © 2017, Iranian Red Crescent Medical Journal.

Item Type: Article
Additional Information: Export Date: 16 February 2020 Correspondence Address: Noras, M.; Faculty of Persian Traditional and Complementary Medicine, Mashhad University of Medical SciencesIran; email: norasmr@mums.ac.ir
Uncontrolled Keywords: Camel milk Chronic hepatitis C HCV genotype 2/ 3 Iran peginterferon alpha peginterferon alpha2a ribavirin adult anemia antiviral activity Article autoimmune disease bleeding disorder clinical article clinical outcome controlled study depression drug efficacy fatigue female heart disease hepatitis C Hepatitis C virus genotype 2 Hepatitis C virus genotype 3 human hyperthyroidism insomnia loss of appetite male mycosis neutropenia nonhuman open study randomized controlled trial real time polymerase chain reaction sustained virologic response thrombocytopenia treatment response
Subjects: WC Communicable Diseases
WI Digestive System
Divisions: Mashhad University of Medical Sciences
Depositing User: mr lib3 lib3
Date Deposited: 18 May 2020 05:36
Last Modified: 18 May 2020 05:36
URI: http://eprints.mums.ac.ir/id/eprint/16741

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