A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia

Prior treatment

• Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.

Other illness

• Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
• Patients with current malignancy or a history of malignancy within 3 years before registration.
• Patients with active AIDS-defining disease requiring treatment. -

Other

• Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.

• Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:
  • Patients who are serum HIV-RNA positive or HIV antibody positive, with HIV-RNA maintained at \<200 copies/mL and a CD4-positive T lymphocyte count of ≥200 cells/µL at screening.
  • Patients with HCV infection who have achieved sustained virologic response (SVR) at least 12 months before registration.
  • Patients with Child-Pugh class A or B liver cirrhosis (Child-Pugh score 5-9).
  • Patients who meet at least one of the following criteria for the diagnosis of liver cirrhosis:
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  • Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
  • Abdominal CT showing changes in liver morphology and/or findings suggestive of portal hypertension.
  • Patients with an Eastern Cooperative Oncology Group Performance Status of 0-2.