Comparison of the degree and speed of virologic response to two treatment options in patients with chronic Hepatitis C.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2015
INTERVENTION: Group 1 started treatment with Gratisovir 400mg tablets (Sofosbuvir‐Pharco), one tablet daily after main meal plus Weight‐Based Dosing (WBD) of Hepaverin capsules (Ribavirin) 1200mg if body weight is 75kg or above and 1000 mg if body weight is <75 kg, twice daily, orally; patients who achieve very rapid Virologic response (i.e. undetectable hepatitis C virus RNA Levels at week 2) will be then randomized to receive treatment for a total duration of 3 months or 6 months. Patients who do not achieve the very rapid virologic response will be treated for a total duration of 6 months. CONDITION: chronic hepatitis C PRIMARY OUTCOME: Sustained virologic response (serum HCV RNA below level of quantification at 12 weeks post treatment). ultra Rapid Virologic Response (i.e. serum HCV RNA below level of quantification or decreased by at least 4 Logs10 at the end of one week of therapy) very Rapid Virologic Response (vRVR) (i.e. Serum HCV RNA below level of quantification at the end of week 2 of therapy) SECONDARY OUTCOME: Adverse drug reactions assessed clinically or by laboratory tests; examples of possible adverse reactions/events are: anemia, thrombocytopenia (assessed by complete blood count), headache, fatigue, abdominal pain, skin rash, itching (assessed clinically by symptoms and signs) INCLUSION CRITERIA: Chronic Hepatitis C genotype 4 infection with HCV RNA levels > 4 Log 10
Epistemonikos ID: dea19ab9964fe8ee5485925ae713947fa9e48ca2
First added on: Aug 25, 2024