Interferon Alfa-2b Alone or in Combination with Ribavirin as Initial Treatment for Chronic Hepatitis C

McHutchison, John G.; Gordon, Stuart C.; Schiff, Eugene R.; Shiffman, Mitchell L.; Lee, William M.; Rustgi, Vinod K.; Goodman, Zachary; Mei, Ling; Cort, Susannah; Albrecht, Janice K.

doi:10.1056/nejm199811193392101

Cited by 3,232 publications

(2,591 citation statements)

References 33 publications

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“…While this activity is not deleterious to most human cells, erythrocytes (RBCs) are adversely affected [2][3][4], and the vast majority of subjects receiving RBV become anemic [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Use of alveolar carbon monoxide to measure the effect of ribavirin on red blood cell survival†

Virtue

Furne

et al. 2004

American J Hematol

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A major side effect of ribavirin (RBV) treatment is anemia. While this anemia is thought to result from increased RBC turnover, RBC survival has not been determined in subjects receiving RBV due to the complexity of the techniques commonly used to quantitate RBC life span. We recently described a simple, rapid, non-invasive technique that utilizes measurements of alveolar carbon monoxide (CO) concentration to determine RBC survival. In the present report, this method was employed to assess RBC survival in patients receiving RBV for hepatitis C. Each of the 31 measurements of RBC survival in 12 subjects with RBV-associated anemia was below the lower limit of normal (77 days), and the average survival (46 ± 14 days) in these subjects was only about 38% of that of healthy controls (122 ± 23 days). Five hepatitis C patients not undergoing RBV treatment had normal RBC survivals (112 ± 17 days). While the mean reticulocyte percentage was significantly elevated in subjects treated with RBV, 59% of these measurements fell within the limits of normal. We conclude that RBV-associated anemia consistently is associated with reduced RBC survival as determined from breath CO measurements and that this reduced survival frequently is not associated with an elevated reticulocyte count. Am.

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“…While this activity is not deleterious to most human cells, erythrocytes (RBCs) are adversely affected [2][3][4], and the vast majority of subjects receiving RBV become anemic [5][6][7].…”

Section: Introductionmentioning

confidence: 99%

Use of alveolar carbon monoxide to measure the effect of ribavirin on red blood cell survival†

Virtue

Furne

et al. 2004

American J Hematol

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“…Across six phase 3 studies of OBV/PTV/r + DSV + RBV, RBV dose reductions were required in only 6.5% of patients, compared with approximately 20% of patients receiving pegIFN/RBV therapy in past studies 1, 2. Head‐to‐head studies have recently reported RBV dose reductions to be lower in patients receiving OBV/PTV/r + DSV + RBV compared with those receiving the first‐generation protease inhibitor, telaprevir, in combination with pegIFN/RBV 17…”

Section: Discussionmentioning

confidence: 99%

“…In combination with standard interferon and pegylated interferon (pegIFN), ribavirin (RBV) has been shown to significantly decrease the risk of post‐treatment viral relapse and increase rates of sustained virological response (SVR) in patients with hepatitis C virus (HCV) infection 1, 2. Despite improving the efficacy of IFN‐based therapy, RBV is associated with haemolytic anaemia,3, 4 a phenomenon driven by accumulation of RBV in erythrocytes and oxidative damage within the red blood cells 5.…”

Section: Introductionmentioning

confidence: 99%

Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin

Feld

Bernstein

Younes

et al. 2018

Liver International

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Background & AimsSome individuals with hepatitis C virus infection treated with direct‐acting antivirals require ribavirin to maximize sustained virological response rates. We describe the clinical management of ribavirin dosing in hepatitis C virus‐infected patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin.MethodsWe performed a post hoc analysis of patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin for 12 or 24 weeks in six phase 3 trials. Multivariate stepwise logistic regression models assessed predictors associated with ribavirin dose adjustments and with developing anaemia.ResultsOf 1548 patients, 100 (6.5%) modified ribavirin dose due to haemoglobin declines, of which 99% achieved sustained virological response at 12 weeks post‐treatment. Median time to first ribavirin dose reduction was 37 days. Low baseline haemoglobin was significantly associated with an increased risk of requiring ribavirin dose modification (odds ratio: 0.618 [0.518, 0.738]; P < .001) and developing anaemia (odds ratio: 0.379 [0.243, 0.593]; P < .001).ConclusionsRibavirin dose reductions were infrequent, occurred early in treatment, and did not impact sustained virological response at 12 weeks post‐treatment. Patients with low baseline haemoglobin should be monitored for on‐treatment anaemia.

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“…Ribavirin is a mutagen and inhibitor of viral RNA polymerase. 13,14 It shows antiviral activity against a variety of RNA viruses and is used to treat infections of hepatitis C virus in combination with interferon-a 15,16 and of lassa fever virus. 17 The method of using antiviral drugs might offer a novel approach for regulated SeV-mediated gene expression in primate ES cells.…”

Section: Introductionmentioning

confidence: 99%

Efficient and stable Sendai virus-mediated gene transfer into primate embryonic stem cells with pluripotency preserved

et al. 2004

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Efficient gene transfer and regulated transgene expression in primate embryonic stem (ES) cells are highly desirable for future applications of the cells. In the present study, we have examined using the nonintegrating Sendai virus (SeV) vector to introduce the green fluorescent protein (GFP) gene into non-human primate cynomolgus ES cells. The GFP gene was vigorously and stably expressed in the cynomolgus ES cells for a year. The cells were able to form fluorescent teratomas when transplanted into immunodeficient mice. They were also able to differentiate into fluorescent embryoid bodies, neurons, and mature blood cells. In addition, the GFP expression levels were reduced dose-dependently by the addition of an anti-RNA virus drug, ribavirin, to the culture. Thus, SeV vector will be a useful tool for efficient gene transfer into primate ES cells and the method of using antiviral drugs should allow further investigation for regulated SeV-mediated gene expression.

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Interferon Alfa-2b Alone or in Combination with Ribavirin as Initial Treatment for Chronic Hepatitis C

Abstract: In patients with chronic hepatitis C, initial therapy with interferon and ribavirin was more effective than treatment with interferon alone.

Cited by 3,232 publications

References 33 publications

Use of alveolar carbon monoxide to measure the effect of ribavirin on red blood cell survival†

Use of alveolar carbon monoxide to measure the effect of ribavirin on red blood cell survival†

Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin

Efficient and stable Sendai virus-mediated gene transfer into primate embryonic stem cells with pluripotency preserved

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