Natural history of anemia associated with interferon/ribavirin therapy for patients with HIV/HCV coinfection.
The natural history of anemia related to interferon/ribavirin (IFN/RBV) treatment in patients with human immunodeficiency virus/hepatitis C virus (HIV/HCV) coinfection is not completely understood. The current 8-week, multicenter, observational study characterized anemia over the course of HCV treatment in patients with HIV/HCV coinfection. Eligible HIV/HCV coinfected patients were receiving care in community-based and academic institutions and were on stable antiretroviral therapy and initiating IFN/RBV therapy. Hb, sEPO, reticulocytes, transfusions, laboratory values (e.g., total bilirubin), and IFN and RBV dosages were monitored weekly. Ninety-one patients were analyzed (mean age, 46 years; 71% on HAART) and 53 patients completed the study. Mean Hb decreased significantly (5.0 g/dl) within 1 week of initiating IFN/RBV therapy (p = 0.0002); Hb nadir occurred at a median of 37 days. Maximum Hb decreases of > or =2.0 g/dl occurred in 56 (62%) patients and > or =3.0 g/dl occurred in 45 (49%) patients. Reticulocyte count increased within the first 2 weeks and sEPO peaked at week 3. Mean increase from baseline to week 2 in reticulocyte count and sEPO, respectively, was 1.3% (n = 74) and 45.0 mIU/ml (n = 80) (p < 0.0001 for each parameter), and from baseline to week 8 was 0.9% (n = 48) and 41.0 mIU/ml (n = 52) (p < or = 0.0001 for each parameter). Adverse events (AEs) were the most common reason for study discontinuation (66% of discontinuing patients). Among the 25 patients who discontinued due to AEs, 84% discontinued due to anemia (n = 21). Significant decreases in Hb were observed in HIV/HCV-coinfected patients within 1 week of initiating IFN/RBV therapy. sEPO and reticulocyte increases were blunted in response to anemia; Hb levels did not return to baseline values and anemia was a frequent reason for discontinuing the study.
Henry
David H
DH
Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, PA 19106, USA. dhhenry@juno.com
Slim
Jihad
J
Lamarca
Anthony
A
Bowers
Peter
P
Leitz
Gerhard
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000740:Anemia / Q000097:blood* / Q000139:chemically induced; D019380:Anti-HIV Agents / Q000008:administration & dosage; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044383:Black People / Q000706:statistics & numerical data; D002452:Cell Count; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004921:Erythropoietin / Q000097:blood; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy*; D006454:Hemoglobins / Q000032:analysis; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011480:Protease Inhibitors / Q000008:administration & dosage; D011994:Recombinant Proteins; D012156:Reticulocytes / Q000166:cytology; D012189:Retrospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D044465:White People / Q000706:statistics & numerical data; D015215:Zidovudine / Q000008:administration & dosage
D019380:Anti-HIV Agents; D000998:Antiviral Agents; D006454:Hemoglobins; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011480:Protease Inhibitors; D011994:Recombinant Proteins; D018894:Reverse Transcriptase Inhibitors; D004921:Erythropoietin; D012254:Ribavirin; D015215:Zidovudine