Clinical trial NCT00910975: Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C
Official title: Tailored Treatment of Hepatitis C Genotype 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C, Genotype 1
Keywords: Hepatitis C virus
Real-time PCR
Treatment
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Sodra Alvsborgs Hospital
name: Skaraborg Hospital
name: Uddevalla Hospital
name: Skane University Hospital
name: Lund University Hospital
name: Karolinska University Hospital
First posted: 2009-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.

Detailed description: The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of HCV. According to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when HCV-RNA becomes undetectable (week 4, 12 or 24). Patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. Still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation.

In this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when HCV RNA level is calculated to be 1 copy/mL, according measurements of HCV RNA on day 14, 21, 28 and 49. This arm also includes an earlier stopping rule: If the HCV RNA does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks.

The advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.

Eligibility criteria: Inclusion Criteria:

* Anti-HCV positive for \> 6 months
* Genotype 1
* Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
* Negative pregnancy test (for fertile women)

Exclusion Criteria:

* Pregnancy or breast-feeding
* Antiviral or immune modulating treatment the last 6 months
* Hepatitis B or HIV infection (HBsAg, anti-HIV)
* Other significant chronic liver disease
* History of bleeding esophageal varices or other signs of decompensation
* Neutrophiles \< 1.0 x 109/L or platelets \< 50 x 109/L. S-creatinine \> 2 x ULN
* History of severe psychiatric disorder
* Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
* Drug abuse, current or during the last year

Primary outcomes:
measure: Medication dose per cured patient
timeFrame: 26 weeks after end of treatment
Secondary outcomes:
measure: Sustained virological response and relapse rate
timeFrame: 26 weeks after end of treatment
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Vastra Gotaland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Magnus Lindh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindh M, Alestig E, Arnholm B, Eilard A, Hellstrand K, Lagging M, Wahlberg T, Wejstal R, Westin J, Norkrans G. Response prediction and treatment tailoring for chronic hepatitis C virus genotype 1 infection. J Clin Microbiol. 2007 Aug;45(8):2439-45. doi: 10.1128/JCM.00577-07. Epub 2007 Jun 20.