Effect of Rifaximin on Thrombocytopenia in Patients With HCV-Related Liver Cirrhosis

After approval by the Ethics Committee of the Faculty of Medicine, Fayoum University, patients were recruited from two tertiary university hospitals in Egypt. Written informed consent was obtained from all patients before enrolment. This was a double-blind, randomised controlled clinical trial that included 165 adults aged 18-75 years with HCV-related liver cirrhosis and thrombocytopenia who had previously received treatment for HCV and achieved a sustained virologic response.

Cirrhosis was diagnosed based on clinical findings (splenomegaly, ascites, and/or esophageal varices), laboratory findings (hypoalbuminemia, hyperbilirubinemia, and/or prolonged prothrombin time), and imaging findings on abdominal ultrasonography, computed tomography, and/or magnetic resonance imaging, with liver biopsy considered when available. The severity of cirrhosis was assessed using the Child-Pugh classification.

Thrombocytopenia was defined as a platelet count <150,000/mm³ and classified as mild (>75,000/mm³), moderate (50,000-75,000/mm³), or severe (<50,000/mm³). Anaemia was defined as haemoglobin <13.5 g/dL in men and <11.5 g/dL in women, and leukopenia as a white blood cell count <4,000/mm³.

Patients were randomly assigned in a 1:1 allocation ratio to the rifaximin group (n=85), which received rifaximin 550 mg orally twice daily for 4 weeks, or the placebo group (n=80). At baseline, all patients underwent clinical evaluation, complete blood count, liver and kidney function tests, and abdominal ultrasonography. A follow-up complete blood count was performed after 4 weeks. Patients were followed weekly in the outpatient hepatology clinic to assess treatment compliance, adverse effects, and cirrhosis-related complications

Inclusion criteria

- Patients ages 18-75 years with HCV-related liver cirrhosis with SVR and thrombocytopenia.

The diagnosis of liver cirrhosis was based on a combination of clinical findings (e.g., splenomegaly, ascites, and/or oesophageal varices), laboratory investigations, and imaging studies, including abdominal ultrasonography, computed tomography, or magnetic resonance imaging. Histological confirmation by liver biopsy was available in selected cases.

Exclusion criteria

• 1) Evidence of bacterial infections in the body by:-
• Clinical history
• Physical examination
• Laboratory investigations:

• WBCs (total and differential count)
• CRP.
• Urine analysis.
• Chest X-ray.
• Ascitic fluid analysis (WBCs & culture and sensitivity) 2) History of variceal bleeding within the 2 weeks preceding this study. 3) Treatment with an antibiotic (including rifaximin) or agents which could have modified the inflammatory process or cytokines (pentoxifylline, steroidal or non-steroidal anti-inflammatory or immunosuppressive drugs) during the last 8 weeks before inclusion.

• Evidence of neoplasia, including hepatocellular carcinoma (HCC). 5) History of red cell or plasma transfusion in the month prior to inclusion in this study.

• History of significant cardiac, pulmonary, renal, or metabolic comorbidities.

• overt hepatic encephalopathy. 8) Active alcohol consumption within the preceding six months. 9) Rifaximin hypersensitivity, 10) Active viral hepatitis requiring direct-acting antiviral therapy 11) Pregnancy or breastfeeding and HIV infection.