ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection

Andreone, Pietro; Colombo, Massimo; Enejosa, Jeffrey; Köksal, İftihar; Ferenci, Péter; Maieron, A; Müllhaupt, Beat; Horsmans, Yves; Weiland, Ola; Reesink, H. W.; Rodrigues, Lino; Hu, Yiran; Podsadecki, Thomas; Bernstein, Barry

doi:10.1053/j.gastro.2014.04.045

Cited by 338 publications

(338 citation statements)

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“…Across the phase 3 studies, the highest rates of anaemia occurred in patients with compensated cirrhosis (TURQUOISE‐II),8, 11, 12, 13, 14 a patient population that typically has higher rates of HCV‐treatment‐related adverse events 22. In the recent TURQUOISE‐III study, OBV/PTV/r + DSV achieved 100% SVR12 in GT1b‐infected patients with compensated cirrhosis, demonstrating that RBV is not required in these patients 23…”

Section: Discussionmentioning

confidence: 99%

“…Where administered, RBV was dosed according to body weight with a total daily dose of 1000 mg (<75 kg) or 1200 mg (≥75 kg). The design, patient characteristics, and overall efficacy and safety outcomes of these studies have been described previously 8, 11, 12, 13, 14…”

Section: Methodsmentioning

confidence: 99%

“…Overall, the frequency and clinical severity of anaemia were low across the six trials; 6.5% of subjects had a decrease in haemoglobin levels to <10 g/dL during treatment with OBV/PTV/r + DSV + RBV, and <1% had a haemoglobin decrease to <8 g/dL 8, 11, 12, 13, 14…”

Section: Introductionmentioning

confidence: 96%

“…Six phase 3 trials evaluated the all‐oral DAA regimen of ombitasvir (OBV, an NS5A inhibitor), paritaprevir (an NS3/4A protease inhibitor identified by AbbVie and Enanta, and dosed with ritonavir, PTV/r) and dasabuvir (DSV, a non‐nucleoside NS5B RNA polymerase inhibitor) with or without RBV in HCV genotype (GT)1‐infected patients that were either treatment naive or pegIFN experienced, with or without compensated cirrhosis 8, 11, 12, 13, 14. Overall, the frequency and clinical severity of anaemia were low across the six trials; 6.5% of subjects had a decrease in haemoglobin levels to <10 g/dL during treatment with OBV/PTV/r + DSV + RBV, and <1% had a haemoglobin decrease to <8 g/dL 8, 11, 12, 13, 14…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 96%

Section: Introductionmentioning

confidence: 99%

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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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“…Ombitasvir (OBV) is a NS5A inhibitor formulated in combination with the NS3/4A protease inhibitor paritaprevir (PTV) and the pharmacokinetic potentiator ritonavir (r) which increases peak and trough exposure to the drugs, meaning that PTV can be administered only once a day [11]. This multi-target 3 DAA regimen, administered concomitantly with the non-nucleoside polymerase inhibitor NS5B dasabuvir (DSV), with or without RBV, has shown high rates of SVR in several studies in patients with genotype 1 HCV [12][13][14][15][16].…”

Section: Introductionmentioning

confidence: 99%

Paritaprevir-Ritonavir, Ombitasvir and Dasabuvir plus Ribavirin to Treat Hepatitis C Genotype 1 Infection after Liver Transplantation: A Single-Center Experience

Otero¹,

Vázquez²,

Suárez³

et al. 2017

Glob Surg

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Hepatitis C virus (HCV) infection is a disease with a significant worldwide impact. In Europe and the United States, chronic hepatitis C is the most common cause of chronic hepatic disease and the main indication for liver transplantation. Recurrent hepatitis C infection is universal among transplant recipients who have detectable viremia at the time of transplantation. Hepatitis C treatment was revolutionized with the introduction of safe, powerful direct action antivirals (DAA), which allow the use of multidrug combinations that can selectively inhibit the targets required for viral replication. One of these regimens combined paritarpevir [NS3/4A protease inhibitor], ombitasvir [NS5A inhibitor] and dasabuvir [NS5B polymerase inhibitor], plus ribavirin and was found to be highly effective (SVR rates of 97% in genotype 1). We report the results of a real-world clinical practice study in a single clinical unit in 22 liver graft recipients, transplanted due to cirrhosis caused by genotype 1 HCV with post-transplantation viral recurrence, who received ombitsavir combined with paritaprevir-ritonavir plus dasabuvir and ribavirin.We found an SVR rate at 12 weeks post-treatment of 100% and a remarkably low rate of adverse events.Conclusion: oral ombitasvir combined with ritonavir-paritaprevir plus dasabuvir and ribavirin for 24 weeks is a highly effective treatment for eliminating HCV in liver transplant recipients with genotype 1 and scant fibrosis, producing few serious adverse effects.

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Ombitasvir, Paritaprevir Co-dosed With Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected With HIV-1

Sulkowski

Eron

Wyles

et al. 2015

JAMA

293

203

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ABT-450, Ritonavir, Ombitasvir, and Dasabuvir Achieves 97% and 100% Sustained Virologic Response With or Without Ribavirin in Treatment-Experienced Patients With HCV Genotype 1b Infection

Cited by 338 publications

References 19 publications

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

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

Paritaprevir-Ritonavir, Ombitasvir and Dasabuvir plus Ribavirin to Treat Hepatitis C Genotype 1 Infection after Liver Transplantation: A Single-Center Experience

Ombitasvir, Paritaprevir Co-dosed With Ritonavir, Dasabuvir, and Ribavirin for Hepatitis C in Patients Co-infected With HIV-1

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