751 The safety and efficacy of viramidine® plus pegylated interferon alpha-2B versus ribavirin plus pegylated interferon alpha-2B in therapy-naïve patients infected with HCV: Phase 3 results

Benhamou, Yves; Pockros, Paul J.; Rodrieuez-Torres, M.; Gordon, S.; Shiffinan, M.; Lurie, Yoav; Afdhal, Nezam H.; Lamon, Kim D.; Kim, Y.; Murphy, Brittany L.

doi:10.1016/s0168-8278(06)80739-7

Cited by 55 publications

(32 citation statements)

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“…Taribavirin (also known as viramidine; Valeant Pharmaceutical International, Costa Mesa, CA) is a liver-targeting, synthetic nucleoside (guanosine) analogue designed for the treatment of patients with CHC. 90,91 In a phase 2 study, 92 significantly fewer patients experienced anemia in the taribavirin treatment groups than in the RBV group (4% versus 27%; P Ͻ 0.0001), with no significant difference in SVR rates. In the recently completed Viramidine's (Taribavirin's) Safety and Efficacy versus Ribavirin (VISER 1) study, 91 taribavirin 600 mg twice a day or RBV 500/600 mg twice a day was given with peg-IFN alpha-2b 1.5 g/kg per week for 24 or 48 weeks.…”

Section: Side Effects Of Chc Treatment and Their Managementmentioning

confidence: 99%

“…90,91 In a phase 2 study, 92 significantly fewer patients experienced anemia in the taribavirin treatment groups than in the RBV group (4% versus 27%; P Ͻ 0.0001), with no significant difference in SVR rates. In the recently completed Viramidine's (Taribavirin's) Safety and Efficacy versus Ribavirin (VISER 1) study, 91 taribavirin 600 mg twice a day or RBV 500/600 mg twice a day was given with peg-IFN alpha-2b 1.5 g/kg per week for 24 or 48 weeks. Consistent with results from the phase 2 study, the incidence of drugassociated anemia was significantly lower in the taribavirin than in the RBV treatment group (5% versus 24%; P Ͻ 0.01).…”

Section: Side Effects Of Chc Treatment and Their Managementmentioning

confidence: 99%

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The effects of HCV infection and management on health-related quality of life

2007

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Section: Side Effects Of Chc Treatment and Their Managementmentioning

confidence: 99%

Section: Side Effects Of Chc Treatment and Their Managementmentioning

confidence: 99%

The effects of HCV infection and management on health-related quality of life

2007

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“…For dialysis patients, ribavirin is generally contraindicated, and alternatives are needed to enhance antiviral effects of IFN. New therapies such as taribavirin, a liver-targeted formulation of ribavirin, may have a lower incidence of treatment-related adverse effects than currently available drugs (126) and may offer specific advantages in this patient group. For renal transplant recipients, ribavirin can be used in combination with IFN in those with restored renal function, but the risk for acute rejection with IFN remains a concern.…”

Section: Discussionmentioning

confidence: 99%

The Kidney Transplant Recipient with Hepatitis C Infection

Terrault

Adey

2007

Clinical Journal of the American Society of Nephrology

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Liver disease secondary to chronic hepatitis C virus (HCV) infection is an important cause of morbidity and mortality in dialysis patients and kidney transplant recipients. Evaluation of patients with chronic HCV infection is warranted to determine stage of disease and the need for HCV therapy. Although combination therapy with interferon (IFN) plus ribavirin is the standard of care for chronic HCV infection, IFN monotherapy is recommended in dialysis patients because ribavirin is contraindicated in the presence of renal failure. The goals of pretransplantation HCV therapy are to decrease the risk for progression of HCV-associated liver disease, stabilize renal function in patients with HCV-related glomerulopathy, and prevent development of HCV-associated renal disease after transplantation. Posttransplantation HCV therapy is generally not recommended because of concerns regarding risk for precipitating acute rejection; however, antiviral therapy may be indicated to treat HCV-related glomerulopathy or prevent progression of chronic hepatitis C in patients with more advanced stages of fibrosis. When treatment is required, restored renal function allows use of combination therapy with IFN and ribavirin. Limitations of current HCV therapy include lack of tolerability and suboptimal response rates. New antiviral agents that can be used in dialysis patients (e.g., ribavirin alternatives) and in the posttransplantation setting (e.g., IFN alternatives) are needed to improve outcomes in these populations.

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“…Taribavirin did not meet the noninferiority to ribavirin effi cacy end point on intent-to-treat basis. It demonstrated a superior safety profi le, with signifi cantly lower (5% vs 24%) anemia rates (hemoglobin < 10 g/dL) [17]. In VISER 2, taribavirin plus pegylated interferon-α-2a was compared with ribavirin plus pegylated interferon-α-2a, and produced results similar to VISER 1, with SVR rates of 40% in taribavirin-treated patients and 55% in ribavirintreated patients.…”

Section: Ribavirin Analogsmentioning

confidence: 98%