NATURAL HISTORY-Hepatitis C Virus/ Human Immunodeficiency Virus Coinfection

Centocor Ortho Biotech

Status and phase

Completed

Phase 2

Conditions

Anemia

Hepatitis C

HIV

Treatments

Drug: Pegylated Interferon and Ribavirin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00315432

CR005134

Details and patient eligibility

About

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.

Full 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

Enrollment

91 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)