NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

Condition(s) targeted: Hepatitis C; Anemia; HIV

Intervention: Pegylated Interferon and Ribavirin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ortho Biotech Products, L.P.

Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech Products, L.P.

The purpose of this study was to describe the time course and extent of hemoglobin (Hb) changes and the erythropoietic response to PEG-IFN/RBV (Pegylated Interferon and Ribavirin)-induced anemia In HCV(hepatitis C virus)/HIV (human immunodeficiency virus) co-Infected subjects.

Official title: )A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Primary outcome: Primary endpoints were change in hemoglobin and serum erythropoietin from baseline to week 8 (or early withdrawal)

Secondary outcome: Other endpoints measured were changes in reticulocytes, platelets, total bilirubin, and RBV dose from baseline to week 8.

Detailed description: Patients receiving combination therapy for chronic hepatitis C virus (HCV) infection (standard or pegylated interferon alfa [PEG-IFN] in combination with ribavirin [RBV]) frequently develop moderate to severe anemia. In large, prospective, clinical trials of PEG-IFN alfa-2b and PEG-IFN alfa-2a, the reported mean decreases in hemoglobin (Hb) were 2. 5 g/dL, and 3. 7 g/dL, respectively. Furthermore, in a retrospective study, 54% of standard interferon/RBV-treated patients had hemoglobin decreases of at least 3 g/dL. It is important to understand the causes, natural history, and risk factors associated with HCV therapy-induced anemia, because such decreases in hemoglobin can result in RBV dose reduction or discontinuation, which may decrease the likelihood of a virologic response by patient. Erythropoietin is an endogenous hormone that acts in the bone marrow to increase the number of erythroid progenitor cells (red blood cells). Normally, a decrease in the hemoglobin level is accompanied by an increase in the serum erythropoietin (sEPO) level, which will ultimately normalize the Hemoglobin level. The relationship between hemoglobin and serum erythropoietin is less apparent in patients with chronic diseases such as cancer and human immunodeficiency virus (HIV) infection. It is not known whether HCV/HIV co-infected patients receiving combination PEG-IFN/RBV therapy have a similarly diminished erythropoietic response to anemia. The objective of this study is to document the pattern of hemoglobin changes and erythropoietic response (from baseline to final assessment) in HCV/HIV co-infected patients receiving combination therapy with IFN / RBV.

N/A

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- HIV- infected patients confirmed by HIV-RNA level

- HCV- infected patients confirmed by PCR(polymerase chain reaction) or branched DNA

(b-DNA)

- Scheduled to commence combination IFN/RBV therapy on Day 1

- Normal serum creatinine

- On stable antiretroviral regimen (for HIV) for at least 4 weeks

- Life expectancy > 6 months

Exclusion Criteria:

- Patients with history of any primary hematologic disease

- Anemia attributable to factors such as iron or folate deficiency, pre-treatment

- Hemolysis or gastrointestinal bleeding

- Has suspected or confirmed significant hepatic disease from an etiology other than

- HCV (e. g. alcohol, HBV DNA, autoimmune disease etc)

A Study to Evaluate the Erythropoietic Response in HCV/HIV Co-Infected Patients Receiving Combination Ribavirin/Interferon Therapy or Ribavirin/PEG-Interferon

Starting date: September 2000
Ending date: November 2003
Last updated: March 17, 2008