Clinical trial NCT03004625 (phase 3, status: completed)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: daclatasvir, asunaprevir, ribavirin
SMILES: COC(=O)N[C@@H](C(C)C)C(=O)N1CCC[C@H]1C1=NC=C(N1)C1=CC=C(C=C1)C1=CC=C(C=C1)C1=CN=C(N1)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)OC)C(C)C, COC1=CN=C(O[C@@H]2C[C@H](N(C2)C(=O)[C@@H](NC(=O)OC(C)(C)C)C(C)(C)C)C(=O)N[C@@]2(C[C@H]2C=C)C(=O)NS(=O)(=O)C2CC2)C2=C1C=CC(Cl)=C2, NC(=O)C1=NN(C=N1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H]1O
Eligibility criteria:

        Inclusion Criteria:

          1. Treatment naïve, interferon-experienced, interferon-intolerant or
             interferon-ineligible, HCV genotype 1b patients with compensated liver disease.

          2. Patients with compensated liver cirrhosis will be capped at 40%.

             Cirrhosis is defined as any one of the following:

               -  Liver biopsy showing cirrhosis

               -  Fibroscan indicative of cirrhosis as evidenced by a result > 12.5 kilopascal

             Absence of cirrhosis is defined as any one of the following:

               -  Liver biopsy within 2 years of Screening showing absence of cirrhosis

               -  Fibroscan within 6 months of Baseline with a result of ≤ 12.5 kilopascal

          3. History of chronic HCV infection > 6 months

          4. Aged at least 20 years

          5. HCV RNA of 10,000 IU/mL or greater

          6. Negative serum or urine pregnancy test result (sensitivity of 25 international units
             or better) for women with childbearing potential within the 24-hour period before the
             first dose of study drugs

          7. Female patients with childbearing potential must agree to use two reliable forms of
             effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine
             device, spermicides, or sponge), at least 1 of which must be a physical barrier
             method, during treatment and for at least 6 months following the last dose of
             ribavirin.

          8. A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can
             be used after end of treatment. All men with female partners of childbearing potential
             must use two reliable forms of effective contraception (combined) during treatment and
             for 6 months following the last dose of ribavirin

          9. Ability to participate and willingness to give written informed consent and to comply
             with the study restrictions.

        Exclusion Criteria:

          1. The existence of baseline NS5A RAV "Lycine 31 (L31F/I/M)" or "Tyrosine93 (Y93H)", by
             using direct-sequencing with RAV of > 20%.

          2. Hepatitis B virus or HIV co-infection.

          3. Patients with experience of ascites, oesophageal varices, or other evidence of hepatic
             decompensation, and/or hepatocellular carcinoma.

          4. History of organ transplantation, except cornea transplantation.

          5. Hemoglobin concentration < 12 g/dl for male, 11 g/dl for female

          6. Platelet count < 50,000/mm3

          7. Prior direct antiviral agents (DAAs) experienced.

          8. History of active malignancy within the last 5 years, with the exception of localized
             or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)

          9. History of severe cardiac disease (e.g., New York Heart Association Functional Class
             III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia's
             requiring ongoing treatment, unstable angina or other unstable, uncontrolled or
             significant cardiovascular disease within 6 months).

         10. Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.

         11. Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's
             disease.

         12. Creatinine Clearance (CrCl) <30 mL/min (as estimated by Cockcroft and Gault)

         13. Pregnant or lactating women.