Low Dose Peginterferon-α 2a for Chronic Hepatitis C, Genotypes 2 or 3, in HIV-coinfected Patients (SAEI_IFN_1)

Sociedad Andaluza de Enfermedades Infecciosas

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic; HIV Infections

Treatments: Drug: Pegylated interferon alfa-2a and Ribavirin; Drug: Pegylated interferon alfa 2a and Ribavirin

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00553930

SAEI_IFN_1

Details and patient eligibility

About

Hypothesis: A regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis C in HIV-coinfected patients.

Objective: To evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic HCV-RNA)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, in HIV-coinfected patients in real use conditions.

Method: Phase IV, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the Servicio Andaluz de Salud will be enrolled. The usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. The primary end point wall be a sustained virologic response (defined as an undetectable serum HCV-RNA after 24 weeks after the cessation of treatment). Likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by ELISA and HPLC, respectively. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.

Enrollment: 71 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age older than 18 years
• HIV infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis C virus (both anti-HCV antibodies and HCV RNA levels detectable in serum) not previously treated.
• Women of child-bearing age: negative pregnancy test
• Ability to understand and sign a written consent form

Exclusion criteria

• Previous interferon treatment
• Pregnancy or breastfeeding
• Acute or chronic hepatitis B infection (positivity for hepatitis B surface antigen or plasma DNA)
• Creatinine clearance < 50 ml/min, according to Cockcroft-Gault
• Decompensated liver disease
• History of organ transplantation
• Concomitant treatment with immunomodulators or didanosine
• Alcohol abuse or use of other recreational drugs
• History of severe psychiatric conditions
• Autoimmune diseases
• Inability to understand and sign a written consent form

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

G 2/3

Experimental group

Description:

Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected.

Treatment:

Drug: Pegylated interferon alfa 2a and Ribavirin

Drug: Pegylated interferon alfa-2a and Ribavirin