Safety and efficacy of viramidine versus ribavirin in ViSER2: Randomized, double-blind study in therapy-naive hepatitis C patients

Marcellin, Patrick; Gish, Robert G.; Gitlin, Norman; Heise, Jamie; Halliman, Deanine G.; Chun, Eric; Rodrı́guez-Torres, Maribel

doi:10.1016/j.jhep.2009.10.015

Cited by 43 publications

(29 citation statements)

References 25 publications

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“…Initial attempts at utilizing taribavirin/viramidine (Figure 1), a liver-targeted ribavirin analogue that elicits fewer side effects, ultimately failed to demonstrate non-inferiority in Phase III clinical trials [113]. Unfortunately, a weight-based dosing regimen was not used for taribavirin/ viramidine in these studies as is utilized for ribavirin.…”

Section: Introductionmentioning

confidence: 99%

The Application and Mechanism of Action of Ribavirin in Therapy of Hepatitis C

Thomas

Ghany

Liang

2012

Antivir Chem Chemother

132

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Ribavirin has been used as an antiviral agent for several decades. Although it has activity against numerous viruses, its major use clinically has been in the treatment of respiratory syncytial virus in paediatric patients and chronic HCV infection in both children and adults. This review highlights the clinical application and mechanism of action of ribavirin and discusses the future role of ribavirin in treatment of HCV where there are intense research efforts to improve therapy.

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Section: Introductionmentioning

confidence: 99%

The Application and Mechanism of Action of Ribavirin in Therapy of Hepatitis C

Thomas

Ghany

Liang

2012

Antivir Chem Chemother

132

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“…[44]. However, in the ViSER1 study taribavirin given at 600 mg BID, was able to improve survival rates in only 44% of patients and is inferior to Ribavirin which improved survival rates in 55 % of patients [45]. Other miscellaneous nucleoside analogues include acyclic triazole analogues synthesised by Zhu R et al [46], pyrrolopyrimidines designed at Valeant [47], alpha-gamma-diketo acids [48] but none of them had entered clinical trials.…”

Section: Pyrimidine Nucleoside Inhibitorsmentioning

confidence: 99%

A Review on Anti-HCV Agents Targeting Active Site and Allosteric Sites of Non-Structural Protein 5b [Ns5b]

Polamreddy

Vishwakarma

Gundla

2016

Int J Pharm Pharm Sci

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Hepatitis C, a chronic disease affecting the global population significantly is caused majorly by Hepatitis C virus [HCV]. Among the several druggable targets explored for Hepatitis C, the viral protein, non-structural protein 5B [NS5B] is the target of choice for researchers as it is the key enzyme in the HCV replication and its active site is conserved among all genotypes. In the recent years the landscape of Hepatitis C therapies, have evolved from Peg-Interferon [PEG-INF]/Ribavirin, to directly acting anti-virus along with PEG-INF and finally, INF free regimens with greater than 90% sustained virological response [SVR]. The launch of Sofosbuvir, a nucleotide inhibitor of NS5B marks the major paradigm in hepatitis C research. Sofosbuvir exhibits, pan-genotypic activity, low barrier to resistance, highly effective and safe. However, the high prices of these medications limit their universal access. This review will focus on progress towards the discovery and development of NS5B inhibitors targeting allosteric sites and active site, covering the chemical class and structure-activity relationships.

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“…Two phase III trials of taribavirin, ViSER 1 and ViSER 2, compared fixed-dose taribavirin 600 mg/day with WBD ribavirin in combination with peginterferon α-2b and α-2a, respectively [49,50]. Both have noted that while anemia rates are significantly lower among patients treated with taribavirin, SVR rates are also lower (did not meet the primary non-inferiority end point) [49,50]. More recently, a phase IIb study using WBD taribavirin (2030 mg/kg/day) demonstrated comparable efficacy and tolerability in all taribavrin doses.…”

Section: Alternatives To Ribavirin: Ribavirin-analogue and Other Impdmentioning

confidence: 99%

Ribavirin: How Does it Work and is it Still Needed?

Bunchorntavakul

Reddy

2011

Curr Hepatitis Rep

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Ribavirin is a synthetic guanosine analogue, which acts against hepatitis C virus (HCV) through several mechanisms that include 1) immune modulation; 2) inhibition of inosine monophosphate dehydrogenase 3) inhibition of RNA-dependent RNA polymerase; 4) induction of HCV mutagenesis; and 5) modulation of interferonstimulated gene expression. Addition of ribavirin to peginterferon-α substantially improves sustained virologic response (SVR) and decreases relapse rates. Ribavirin can be associated with hemolytic anemia. However, recent data suggest that SVR is not negatively impacted by treatmentinduce anemia. Notably, optimal dosing strategy and the proper management of anemia are crucial to achieve the best treatment outcome. Several advances have been made in the areas relevant to ribavirin, such as the discovery of inosine triphosphatase gene as a promising pharmacogenetic marker and a predictor of anemia, and the role for erythropoiesis-stimulating agent in the management of anemia related to ribavirin use. Recent observations indicate that ribavirin will remain as a critical component of HCV therapy, even in the context of direct acting antivirals.

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Safety and efficacy of viramidine versus ribavirin in ViSER2: Randomized, double-blind study in therapy-naive hepatitis C patients

Cited by 43 publications

References 25 publications

The Application and Mechanism of Action of Ribavirin in Therapy of Hepatitis C

The Application and Mechanism of Action of Ribavirin in Therapy of Hepatitis C

A Review on Anti-HCV Agents Targeting Active Site and Allosteric Sites of Non-Structural Protein 5b [Ns5b]

Ribavirin: How Does it Work and is it Still Needed?

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