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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G 2/3 | Experimental | Patients with chronic hepatitis or compensated cirrhosis by hepatitis C virus, genotypes 2 or 3, and HIV-coinfected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegylated interferon alfa-2a and Ribavirin | Drug | All patients will be treated with the combination of pegIFN-α 2a (135 μg per week)plus oral Ribavirin at a dose of 800 mg per day. The treatment will be continued up to 20 weeks after reaching an undetectable plasma RNA-HCV. Treatment will be discontinued for patients who did not achieve a reduction of al least 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 and will be considered as viral failures. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response(undetectable serum HCV-RNA) | 24 weeks after the cessation of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Relationships between the plasma interferon an ribavirin concentrations and efficacy. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. | Throughout treatment and 24 weeks after finishing it |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis F Lopez-Cortes, MD, PhD | Infectious Disease Service. Hospitales Universitarios Virgen del Rocio. Sevilla. Spain | Study Director |
| Antonio Rivero, MD, PhD | Hospital Universitario Reina SofÃa. Córdoba. Spain | Principal Investigator |
| Mercedes Gonzalez, MD, PhD | Hospital Universitario Virgen de la Victoria. Malaga. Spain | Principal Investigator |
| Angel Garcia, MD | Hospital Universitario de Valme. Sevilla. Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Diseases Service.Hospitales Universitarios Virgen del Rocio | Seville | Sevilla | 41013 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22235243 | Derived | Lopez-Cortes LF, Ruiz-Valderas R, Jimenez-Jimenez L, Gonzalez-Escribano MF, Torres-Cornejo A, Mata R, Rivero A, Pineda JA, Marquez-Solero M, Viciana P; Grupo para el Estudio de las Hepatitis Viricas (HEPAVIR) de la Sociedad Andaluza de Enfermedades Infecciosas. Influence of IL28B polymorphisms on response to a lower-than-standard dose peg-IFN-alpha 2a for genotype 3 chronic hepatitis C in HIV-coinfected patients. PLoS One. 2012;7(1):e28115. doi: 10.1371/journal.pone.0028115. Epub 2012 Jan 3. |
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| Pegylated interferon alfa 2a and Ribavirin | Drug | Pegylated interferon alfa 2a (135 ug/week)and Ribavirin (800 mg/day). Duration: 20 weeks after reaching an undetectable plasma RNA_HCV. Treatment will be discontinued for patients who did not achieve a decrease of >= 2 log10 IU/ml in plasma HCV RNA levels with respect to baseline at week 12 of treatment or earlier and will be considered as viral failures. |
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|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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