Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial

Welzel, Tania M.; Asselah, Tarik; Dumas, Emily O.; Zeuzem, Stefan; Shaw, David R.; Hazzan, Rawi; Forns, Xavier; Pilot‐Matias, Tami; Lü, Wenjing; Cohen, Daniel E.; Feld, Jordan J.

doi:10.1016/s2468-1253(17)30071-7

Cited by 48 publications

(28 citation statements)

References 23 publications

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“…Previous studies evaluating the safety of PTV/r/OBV/DSV have associated the development of SAEs with a more advanced liver disease; thus, the rate of expected SAEs was low. Furthermore, two patients (1%) presented significant elevation (>5× ULN) of ALT during antiviral therapy, which has also been described in studies evaluating PTV/r/OBV/DSV in non‐cirrhotic patients . This effect was mild and did not entail treatment discontinuation.…”

Section: Discussionsupporting

confidence: 60%

Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort

Puigvehí

Cuenca

Viu

et al. 2018

Liver International

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Section: Discussionsupporting

confidence: 60%

Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort

Puigvehí

Cuenca

Viu

et al. 2018

Liver International

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“…It is worth pointing out, that RASs against dasabuvir have very little impact on the treatment of GT 1b patients as reported by clinical trials [9,21–23,48,49] and literature reporting real life treatment data [50]. The known RASs C445F, A553V and S556G were found as baseline polymorphisms in GT 2b and 3a samples.…”

Section: Discussionmentioning

confidence: 95%

Baseline dasabuvir resistance in Hepatitis C virus from the genotypes 1, 2 and 3 and modeling of the NS5B-dasabuvir complex by thein silicoapproach

Akaberi

Bergfors

Kjellin

et al. 2018

Infection Ecology & Epidemiology

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Background: Current combination treatments with direct-acting antiviral agents (DAAs) can cure more than 95% of hepatitis C virus (HCV) infections. However, resistance-associated substitutions (RASs) may emerge and can also be present in treatment-naïve patients. Methods, results and discussion: In this study, a semi-pan-genotypic population sequencing method was developed and used to assess all NS5B amino acid variants between residue positions 310 and 564. Our method successfully sequenced more than 90% of genotype (GT) 1a, 1b, 2b and 3a samples. By using the population sequencing method with a cut-off of 20%, we found the dasabuvir RASs A553V and C445F to be a baseline polymorphism of GT 2b (8 out of 8) and GT 3a (18 out of 18) sequences, respectively. In GT 1a and 1b treatment-naïve subjects (n=25), no high-fold resistance polymorphism/RASs were identified. We further predicted dasabuvir’s binding pose with the NS5B polymerase using the in silico methods to elucidate the reasons associated with the resistance of clinically relevant RASs. Dasabuvir was docked at the palm-I site and was found to form hydrogen bonds with the residues S288, I447, Y448, N291 and D318. The RAS positions 316, 414, 448, 553 and 556 were found to constitute the dasabuvir binding pocket.

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“…Our study showed that the percentage of inmates undergoing 8‐week treatment courses was lower than in the general population (0.5% vs 10.5%). Studies that have demonstrated the efficacy of shorter therapies in selected populations without cirrhosis indicate the need to reduce courses of treatment. What is more, the introduction of new drugs such as voxilaprevir, glecaprevir and pibrentasvir in the near future will facilitate the use of these shorter therapies and may be able to avoid the abandonment of treatment among inmates when they are released …”

Section: Discussionmentioning

confidence: 99%

Comparison of effectiveness and discontinuation of interferon‐free therapy for hepatitis C in prison inmates and noninmates

Marco¹,

Roget

Cervantes

et al. 2018

Journal of Viral Hepatitis

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Chronic hepatitis C treatment with direct acting antiviral (DAA) therapy during incarceration is an attractive option, due to its short duration and to the possibility of directly observed treatment or supervision. The aim of this study is to compare the effectiveness and rates of discontinuation of DAA treatment in prisoners and nonprisoners. We studied all patients treated in the 10 prisons of Catalonia and at 3 public hospitals in the Barcelona area between 1 January 2015 and 30 April 2016. We analysed sustained viral response (SVR) and rates of discontinuation through intention-to-treat and modified-intention-to-treat analyses, the latter excluding discontinuations due to release from prison. One hundred and eighty-eight inmates and 862 noninmates were included. Prisoners were significantly younger than nonprisoners, with higher proportions of men, drug users, HIV infection, genotypes 1a and 3 and more treatment with psychiatric drugs. Overall, 98.4% of patients completed treatment. The discontinuation rate was low, but higher in inmates (3.7% vs 1.2% noninmates; P = .003) and in community patients >65 years old (2.8% vs 1.2% in under 65 seconds; P = .008). Among the inmates, 7 (42.8%) discontinuations were due to release. SVR was 93.1% in inmates vs 96.5% in noninmates (P = .08) by intention-to-treat and 95.1% vs 96.5% (P = .37) by modified intention-to-treat. Virologic failure rates were similar (3.8% vs 3% in noninmates; P = .60). SVR, virologic failure and discontinuation rates were similar in inmates and noninmates. Currently, prisons are considered a priority for the implementation of DAA. Improved coordination between penitentiary and community health systems would help to ensure therapeutic continuity in released prisoners.

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Ombitasvir, paritaprevir, and ritonavir plus dasabuvir for 8 weeks in previously untreated patients with hepatitis C virus genotype 1b infection without cirrhosis (GARNET): a single-arm, open-label, phase 3b trial

Cited by 48 publications

References 23 publications

Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort

Eight weeks of Paritaprevir/r/Ombitasvir + Dasabuvir in HCV genotype 1b with mild‐moderate fibrosis: Results from a real‐world cohort

Baseline dasabuvir resistance in Hepatitis C virus from the genotypes 1, 2 and 3 and modeling of the NS5B-dasabuvir complex by thein silicoapproach

Comparison of effectiveness and discontinuation of interferon‐free therapy for hepatitis C in prison inmates and noninmates

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