Adult patients diagnosed with chronic compensated hepatitis C, without previous treatment and co-infected with HIV. Infections and Infestations Chronic hepatitis C and HIV
Conditions
Interventions
The objective of this protocol is to obtain data on the effectiveness and safety of the combined treatment with pegylated-interferon alpha 2b and ribavirin in comparison with the combined treatment wi
Sponsors
Barcelona Hospital Clinic Villarroel (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men or women 18-65 years of age 2. Chronic hepatitis C defined by elevated alanine transaminase (ALT) (1.5 times the upper limit of normal at least on two separate occasions over four weeks, before incorporation in the study 3. Anti-hepatitis C virus (anti-HCV) positive according to enzyme-linked immunosorbent assay (ELISA) and positive ribonucleic acid-hepatitis C virus (RNA-HCV) in serum by polymerase chain reaction (PCR) 4. Hepatic biopsy in the 18 months before inclusion in the study showing changes of chronic hepatitis, with or without cirrhosis 5. Compensated hepatopathy, with the following hematological and biochemical criteria: a. Hemoglobin =11 g/dl in females and =12 g/dl in males b. Total leucocytes =3,000 /mm^3 and neutrophyls =1,500 /mm^3 c. Platelets = 80,000 /mm^3 d. Normal prothrombin time and plasmatic albumin e. Normal bilirubin (unless other factors not related to hepatitis, such as Gilbert’s disease, justify its elevation) f. Normal serum creatinine (or 250 cel/mm^3 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Any other cause of hepatopathy in the patient’s history or in the biopsy (if applicable) different from chronic hepatitis C, among others 2. Infection by hepatitis B virus (HBsAg positive), primitive hemochromatosis, alpha-1 antitrypsin deficiency and Wilson’s disease, autoimmune hepatitis, alcoholic hepatopathy, obesity induced hepatopathy, pharmacological hematopathy 3. Hemoglobinopathies included, among others, thalassemia (major and minor) 4. Decompensated hepatopathy defined by background or presence of ascites, bleeding varicose veins or spontaneous encephalopathy 5. Prior treatment of hepatitis C with any antiviral or immunomodulator medication, including ribavirin, thymosin and corticoids (when corticoids have been used only as treatment of hepatopathy, not for other indications) 6. In female patients, pregnancy or breastfeeding 7. Any known disorder which may interfere with the patient’s participation and with completion of the treatment or cause an increased risk of producing relevant side effects, such as: a. Patients with chronic renal failure on hemodialysis b. Psychiatric disorders, especially severe depression or other severe psychiatric disorders, such as major psychosis, suicidal ideas and/or suicide attempt The following is understood to be severe depression: a. Individuals that have been hospitalized due to depression b. Individuals who have received electroconvulsive therapy for depression c. Individuals whose depression has caused a prolonged work absence and/or significant alteration of daily activities. It may be possible to consider including in the study individuals with a background of mild depression as long as an evaluation of their mental state prior to the treatment confirms that they are clinically stable. 8. Patients being treated with efavirenz, except if the patient has been treated with said medication for more than three months and has been assessed positively by a psychiatrist 9. Central nervous system (CNS) traumatism or active epilepsy requiring medication 10. Significant cardiovascular dysfunction six months before (e.g. angina, congestive cardiac failure, recent myocardial infarction, severe hypertension or significant arrhythmia) or significant alteration in the echocardiogram (ECG) 11. Badly controlled diabetes mellitus 12. Chronic pulmonary disease (e.g. chronic obstructive pulmonary disease) 13. Autoimmune disease (e.g. intestinal inflammatory disease, thromboticytopecnic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis) 14. Substance abuse such as alcohol (=80 g /day), inhalated or intravenously (IV)-administered drugs. If the individual has a background of substance abuse and is a candidate for inclusion in the protocol, he/she must have abstained from said drug for at least a year. 15. Clinically significant retinal anomalies 16. Any other disorder that, in the opinion of the researcher, makes the patient inappropriate for recruitment or may interfere with his participation and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To analyse the proportion of patients with sustained virological response maintained (HCV-RNA not detectable in plasma after 24 weeks to end the therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To analyse the proportion of patients with a virological response (HCV-RNA not detectable or =2 log10 drop) after 12, 24, 34, 36, and 48 weeks of therapy 2. To analyse the tolerability and the safety of both treatments in the HIV-HCV co-infected patients 3. To analyse the clinical evolution of these patients 4. To determine parameters of quality of life in the treated patients 5. To evaluate the appearance and evolution of lipodystrophy 6. To evaluate the appearance of mitochondrial toxicity in the patients treated with nucleoside reverse transcriptase inhibitor (NRTI) plus ribavirine 7. To evaluate the histological response in the respondent patients as well as in the non-respondent ones | — |
Countries
Spain
Outcome results
None listed