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

A Multicenter, Single-Arm, Open-Label Phase 2 Study of Once-Weekly Foscenvivint in Patients With Liver Cirrhosis Due to HIV/HCV Co-infection in the Setting of Hemophilia

This is a phase 2 study to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.

This is a multicenter, single-arm, open-label phase 2 study of foscenvivint administered intravenously once-weekly for 24 weeks. A follow-up visit will be conducted 4 weeks after the final administration.

Eligible patients are those with Child-Pugh class A or B liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.

Inclusion Criteria:

• Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:

  1. 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.

  2. 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:

  1. Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.

  2. 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.

Exclusion Criteria:

• Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
• Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.
• Patients with current malignancy or a history of malignancy within 3 years before registration.
• Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.
• Patients with active AIDS-defining disease requiring treatment. -