Anemia and clinical outcomes in hepatitis C

Benhamou, Yves

doi:10.1016/j.jhep.2007.04.007

Cited by 2 publications

(1 citation statement)

References 18 publications

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“…The use of a fixed dose of VRD and weight‐based dosing of RBV in the current study may therefore have led to lower SVR rates in the VRD group 24. A phase IIb study was recently undertaken to compare the safety and efficacy of three weight‐based VRD doses (53 patients received between 20 and 30 mg/kg of VRD per day) versus weight‐based RBV, both administered with peg‐IFN, in therapy‐naïve patients with HCV genotype 1 infection 25.…”

Section: Discussionmentioning

confidence: 92%

A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results #

et al. 2009

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Pegylated interferon (peg-IFN) and ribavirin (RBV) are effective in eradicating the hepatitis C virus in more than half of patients. However, anemia arising from RBV-induced hemolysis can prompt dose reductions and lower sustained virologic response (SVR) rates. In early clinical trials, Viramidine (VRD, renamed taribavirin), an RBV prodrug, was associated with less anemia and VRD given at 600 mg twice daily (BID) appeared to provide the best safety with comparable efficacy to RBV. The phase III Viramidine's Safety and Efficacy versus Ribavirin 1 (ViSER1) study randomized 972 treatment-naïve patients with chronic hepatitis C to fixed-dose VRD (600 mg BID) or weight-based RBV (1000 or 1200 mg/day), each given with peg-IFN alfa-2b at 1.5 g/kg/week. The primary efficacy endpoint was SVR rate, and the primary safety endpoint was hemoglobin (Hb) event rate (percent of patients with Hb < 10 g/dL or at least a 2.5-g/dL decrease from baseline). SVR rates were 37.7% with VRD (244/647) and 52.3% with RBV (170/325). Thus, the ViSER1 study failed to demonstrate the primary noninferiority efficacy endpoint. Significantly fewer patients had Hb events with VRD (353/647; 54.6%) compared to those with RBV (272/325; 83.7%) (P < 0.001), and significantly fewer developed anemia (Hb < 10 g/dL) with VRD (34/647; 5.3%) compared to those with RBV (76/325; 23.5%) (P < 0.001). Conclusion: Fixed doses of VRD failed to demonstrate noninferiority to RBV in producing SVR rates. The incidence of anemia was approximately four-fold significantly lower with VRD than with RBV. These results suggest fixed-dose VRD given 600 mg BID is insufficient to treat patients with chronic hepatitis C; a weight-based dosing trial of viramidine is currently under way. (HEPATOLOGY 2009;50:717-726.) C ombination therapy with pegylated interferon alfa (peg-IFN) and ribavirin (RBV) is the standard of care for the treatment of patients with chronic hepatitis C, resulting in overall sustained virologic response (SVR) rates of 54%-56%. 1,2 However, adherence to the prescribed regimen of peg-IFN and RBV, especially during the first 12 weeks of treatment, is critical to viral clearance. 3 A recent study showed that when patients infected with hepatitis C virus (HCV) genotype 1 maintained less than 80% of their cumulative RBV dose, the SVR rate was 52% compared with 67% for those who maintained more than 97% of their RBV dose. 4 Patient characteristics such as ethnicity (African American) and coinfection with human immunodeficiency virus, as well as viral genotype (1, 4, 5, or 6) and adverse effects, may impair treatment outcomes and lower SVR

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Section: Discussionmentioning

confidence: 92%

A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results #

et al. 2009

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Peginterferon-α-2a (40 kD) Plus Ribavirin

Keam

Cvetković

2008

Drugs

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Peginterferon-alpha-2a (40 kD) [PEGASYS] is a conjugate of recombinant interferon-alpha-2a and a 40 kD branched polyethylene glycol (PEG) moiety that is highly active against hepatitis C virus (HCV). Ribavirin (COPEGUS) is a synthetic nucleoside analogue that acts in synergy with the antiviral activity of peginterferon-alpha-2a (40 kD). The combination of subcutaneous peginterferon-alpha-2a (40 kD) once weekly plus oral ribavirin twice daily is widely approved for use in adult patients with chronic hepatitis C, including those with persistently 'normal' ALT activity or HIV-HCV co-infection, and is recommended as a first-line treatment option for patients with chronic hepatitis C and compensated liver disease. In randomized, phase III trials, the combination has consistently demonstrated good therapeutic efficacy (i.e. high sustained virological response [SVR] rates) and has been generally well tolerated in both treatment-naive and treatment-experienced patients with chronic hepatitis C, including those with compensated advanced liver disease. Several baseline and dynamic (on-treatment) predictors of SVR that can be used to guide and optimize therapy were also determined in these trials and in subsequent analyses. By utilizing these predictors, therapy with peginterferon-alpha-2a (40 kD) plus ribavirin can be individualized to achieve the optimal balance between efficacy and tolerability, further increasing the usefulness of this drug combination. Thus, peginterferon-alpha-2a (40 kD) plus ribavirin remains a valuable therapy in patients with chronic hepatitis C, as a first-line option in those with compensated liver disease and as a second-line therapy in those with advanced liver disease.

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Anemia and clinical outcomes in hepatitis C

Cited by 2 publications

References 18 publications

A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results #

A phase III study of the safety and efficacy of viramidine versus ribavirin in treatment-naïve patients with chronic hepatitis C: ViSER1 results #

Peginterferon-α-2a (40 kD) Plus Ribavirin

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