Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial

Poordad, Fred; Lawitz, Eric; Reddy, K. Rajender; Afdhal, Nezam H.; Hézode, Christophe; Zeuzem, Stefan; Lee, Samuel S.; Calleja, José Luís; Brown, Robert S.; Craxı̀, Antonio; Wedemeyer, Heiner; Nyberg, Lisa M.; Nelson, David R.; Rossaro, Lorenzo; Balart, Luis A.; Morgan, Timothy R.; Bacon, Bruce R.; Flamm, Steven L.; Kowdley, Kris V.; Deng, Weiping; Koury, Kenneth; Pedicone, Lisa D.; Dutko, Frank J.; Burroughs, Margaret; Alves, Katia; Wahl, Janice; Brass, Clifford A.; Albrecht, Janice K.; Sulkowski, Mark S.

doi:10.1053/j.gastro.2013.07.051

Cited by 49 publications

(39 citation statements)

References 18 publications

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“…Poordad et al reported lower SVR rates among patients receiving < 50% of the total milligrams of ribavirin protocol assignment than those receiving ≥ 50%. Our patient received ≥ 50% of the total ribavirin dose [17] .…”

Section: Discussionmentioning

confidence: 85%

Sustained Virologic Response with Triple Therapy in a Hemodialysis Patient with Chronic HCV Infection

Kaygusuz¹,

Gül²,

Gülhan³

2014

Mediterr J Infect Microb Antimicrob

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Chronic hepatitis C virus (HCV) infection is more prevalent and has been proven to be an independent risk factor over mortality among hemodialysis patients than normal population. Since sustained virologic response (SVR) is so beneficial and may be maintained in 90-100% of post-transplant cases, treatment of chronic HCV infection is strongly suggested for all patients undergoing renal transplantation. A 45-year-old male patient had been offered to have renal transplantation due to chronic renal failure, and referred to our clinic because of chronic HCV infection (HCV-RNA positive). He had received hemodialysis three times a week since 2007. The patient was diagnosed with chronic HCV infection fifteen years ago and was given a 48-week lasting IFN therapy in 2000 and a subsequent therapy of PEG-IFN-α2a for 48 weeks in 2004. Although both therapies had yielded end of treatment responses, subsequent relapses occurred. The patient was given a combination treatment involving PEG-IFN-α2a (135 μg/wk) for 24 weeks and ribavirin (200 mg/day) for 24 weeks and telaprevir (3 x 750 mg) for the first 12 weeks, and a weekly control visit in our clinic. The therapy was generally well tolerated and SVR was achieved. Triple therapy might be used as a treatment option in hemodialysis patients with genotype 1 chronic HCV infections.

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Section: Discussionmentioning

confidence: 85%

Sustained Virologic Response with Triple Therapy in a Hemodialysis Patient with Chronic HCV Infection

Kaygusuz¹,

Gül²,

Gülhan³

2014

Mediterr J Infect Microb Antimicrob

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“…Poordad et al [12] documented that a reduction in the dose of RBV can be the primary approach in the management of anaemia in patients receiving triple therapy with BOC, without affecting rates of SVR [9] ; therefore, the identification of those patients who are at higher risk of developing severe anaemia may have important clinical relevance [12] .…”

Section: Discussionmentioning

confidence: 99%

ITPA and SLC29A1 Genotyping for the Prediction of Ribavirin Dose Reduction in Anti-HCV Triple Therapy with Protease Inhibitors

Lombardi

Landonio²,

Magni³

et al. 2015

Pharmacology

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Chronic hepatitis C is one of the most important causes of liver disease, leading to cirrhosis, hepatic decompensation and hepatocellular carcinoma. Recently some important advances in therapy have been achieved with the introduction of first wave, first generation direct acting antiviral agents (DAAs) such as boceprevir (BOC), in combination with pegylated interferon (Peg-IFN) and ribavirin (RBV). The superior rate of sustained virological response with this treatment is accompanied by an elevated frequency of anaemia. Several studies have evidenced the importance of single nucleotide polymorphisms (SNPs) in inosine triphosphatase (ITPA) and solute carrier family 29, member 1 (SLC29A1) genes in the development of this adverse event. Here, we investigated haemoglobin levels and the best-known functional SNPs in ITPA and SLC29A1 genes in 22 patients treated with triple therapy with BOC/Peg-IFN/RBV. The identification of ITPA protective and SLC29A1 risk genotypes still appears to be a current methodology in RBV dosing during hepatitis C virus therapy with DAAs.

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“…Similarly, no conclusive data exists about transfusion requirements predicting treatment outcomes. Recently, Poordad et al [22] evaluated the management of anemia in patients on triple therapy (boceprevir) and concluded that RBV reduction was an effective primary management approach. Additionally, RBV dose reduction did not affect SVR.…”

Section: Discussionmentioning

confidence: 99%

HCV Triple Therapy is Equally effective in African-Americans and Non-African-Americans

Wysocki

Newby

Balart

et al. 2014

J. Racial and Ethnic Health Disparities

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Real-world experience with HCV medications differs from original the index studies. AfricanAmericans (AA) are commonly underrepresented in clinical trials. Therefore, we hypothesized that postmarketing experience with the first generation HCV protease inhibitors (PI) (telaprevir and boceprevir) differs from premarket reports in clinically meaningful ways regarding patient race. We conducted a single-center, retrospective, observational analysis to evaluate the efficacy of HCV triple therapy in a nontrial setting. Clinical response and quantitative laboratory values were compared between AA and non-AA patients throughout the duration of treatment. Patients were included if they started triple therapy treatment after July 2011 and are not a part of any other clinical/pharmaceutical trials. Thirty-five patients with HCV genotype 1 were included in this study-22 non-AA and 13 AAs. AAs had a higher BMI compared to non-AA (33.6 vs 28.8, p=0.046). "High" baseline HCV RNA values (above 800,000 copies) were more prevalent in AA (69.2 %) vs non-AA (63.6 %). AA had less favorable IL28B genotypes; only 7.7 % had type CC compared to 40.9 % of non-AA. SVR12 was achieved 82 % of the time with each PI but there was no significance in type of PI used (p=1.00). Patients with cirrhosis were less likely to achieve SVR12 (40 %) compared to those without cirrhosis (88 %, p = 0.013). Thirty-three percent of the patients who received blood transfusions did not achieve SVR12 while every patient who did not require transfusion achieved SVR12 (p=0.001). All patients with IL28B genotype CC achieved SVR12 (p=0.007). SVR12 did not differ among AA (77 %) and non-AA (86.4 %) (p=0.528).

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Effects of Ribavirin Dose Reduction vs Erythropoietin for Boceprevir-Related Anemia in Patients With Chronic Hepatitis C Virus Genotype 1 Infection—A Randomized Trial

Cited by 49 publications

References 18 publications

Sustained Virologic Response with Triple Therapy in a Hemodialysis Patient with Chronic HCV Infection

Sustained Virologic Response with Triple Therapy in a Hemodialysis Patient with Chronic HCV Infection

<b><i>ITPA</i></b> and <b><i>SLC29A1</i></b> Genotyping for the Prediction of Ribavirin Dose Reduction in Anti-HCV Triple Therapy with Protease Inhibitors

HCV Triple Therapy is Equally effective in African-Americans and Non-African-Americans

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