Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)
- Registration Number
- NCT01380938
- Lead Sponsor
- Casa Sollievo della Sofferenza IRCCS
- Brief Summary
WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.
- Detailed Description
The investigators are going to compare weight-based dosages of ribavirin, in combination with Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24, whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in arm B will be treated till week 48.
A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1150
- Patients with chronic hepatitis C virus (HCV) infection (both HCVAb and HCV RNA positive)
- Patients with HCV genotype 2 or 3
- Age 18-70 years
- Naïve patients or previously treated only with standard interferon monotherapy
- Female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment
- Previous treatment with ribavirin
- Cirrhosis (CHILD PUGH B and C)
- Evidence of Hepatocellular carcinoma
- Pregnancy
- Retinopathy class I or II
- Alcohol consumption > 40 gr/day
- Chronic cardiac or respiratory diseases
- HIV or HBsAg or HDV positivity
- Hemoglobin < 8.5 gr/dL
- WBC < 3.500/mm3
- PLT < 80.000/mm3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Peginterferon alpha-2a + Ribavirin Patients enrolled in Arm A will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 1000 mg/day for patients with a body weight \< 75 kg or 1200 mg/day for those with a body weight \> 75 kg. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm A), whereas those without RVR will be treated for 24 weeks (Arm A) Arm B Peginterferon alpha-2a + Ribavirin Patients enrolled in Arm B will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm B), whereas those without RVR will be treated for 48 weeks (Arm B)
- Primary Outcome Measures
Name Time Method Sustained virological Response (SVR) 6 months after the end of treatment The primary measure of efficacy will be HCV RNA not detectable in serum samples 24 weeks after the end of therapy (SVR).
- Secondary Outcome Measures
Name Time Method Rapid virological response (RVR) On treatment week 4 proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment
Trial Locations
- Locations (24)
Infectious Diseases Unit
🇮🇹Catania, Italy
Clinical Medicine Unit "Mater Dei"
🇮🇹Bari, Italy
Università di Bari
🇮🇹Bari, Italy
Medicine Unit
🇮🇹Venosa, Italy
Infectious Diseases Unit "V. Emanuele"
🇮🇹Bisceglie, Italy
Hepatology Unit
🇮🇹Catania, Italy
IRCCS "De Bellis"
🇮🇹Castellana, Italy
Gastroenterology Unit
🇮🇹Mottola, Italy
Infectious Diseases
🇮🇹Siracusa, Italy
Gastroenterology Unit Arcispedale "S. Anna"
🇮🇹Ferrara, Italy
Gastroenterology Unit "Cardarelli"
🇮🇹Napoli, Italy
Internal Medicine University of Firenze
🇮🇹Firenze, Italy
Hospital "V. Cervello"
🇮🇹Palermo, Italy
Infectious Diseases Unit IRCCS "San Matteo"
🇮🇹Pavia, Italy
USL Napoli 1
🇮🇹Napoli, Italy
Campus Biomedico University
🇮🇹Roma, Italy
Hepatology Unit "san Camillo"
🇮🇹Roma, Italy
Hepatology Unit "S. Pertini"
🇮🇹Roma, Italy
Ospedale "Villa Betania"
🇮🇹Roma, Italy
IRCCS "L. Spallanzani"
🇮🇹Rome, Italy
Infectious Diseases Unit Ospedale Civile
🇮🇹Sassari, Italy
IRCCS "Casa Sollievo della Sofferenza"
🇮🇹San Giovanni Rotondo, Italy
SS. Annunziata
🇮🇹Taranto, Italy
Medical Clinic University of Palermo
🇮🇹Palermo, Italy