THU-142-Sofosbuvir + velpatasvir + voxilaprevir in DAA failure patients with cirrhosis: Final results of the French compassionate use program

Hézode, Christophe; Guyader, Dominique; Nguyen‐Khac, Eric; Larrey, Dominique; Truchi, Régine; Martino, Vincent Di; Calmus, Yvon; Franza, Anne Minello; Giuily, Nathalie; Mokhtari, Saadi; Hartig, Kerstin; Cotte, Laurent; Ribard, D; Valantin, Marc‐Antoine; Bonyhay, Luminita; Antoni, M.; Bronowicki, Jean–Pierre; Combis, Jean‐Marc; Pilette, Christophe; Zamora, Christophe; Erard, Domitille; Arpurt, Jean‐Pierre; Renou, Christophe; Bourlière, Marc; Grando, Véronique; Canva, V.

doi:10.1016/s0618-8278(19)30417-7

Cited by 5 publications

(2 citation statements)

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“…Finally, a total of 24 studies were included for analysis ( Figure 1 ) . Most studies had either a low risk [ 6 , 9 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 ] or moderate risk of bias [ 10 , 11 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ] ( Supplementary Table S2 ). Most studies were reported from the European region (37.5%), followed by the Americas region (29.2%), Western Pacific region (20.8%), Eastern Mediterranean region (8.3%), and African region (4.2%).…”

Section: Resultsmentioning

confidence: 99%

Treatment Outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir in Direct-Acting Antiviral-Experienced Hepatitis C Virus Patients: A Systematic Review and Meta-Analysis

Devan,

Tiong,

Neo

et al. 2023

Viruses

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About 5% of chronic hepatitis C (CHC) patients experienced treatment failure with direct-acting antiviral (DAA) treatment. The global data on the practice and treatment outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) in DAA-experienced CHC patients remains sparse. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of SOF/VEL/VOX as a salvage treatment in DAA-experienced CHC patients. We searched five electronic databases from inception to 31 January 2023. The study outcomes were SVR12 and treatment-related adverse effects, with subgroup analysis performed based on genotype, cirrhosis, HCC, prior SOF/VEL exposure, and region. We identified and analyzed data from 24 studies (2877 DAA-experienced CHC patients); 17.2% had prior SOF/VEL exposure, 25% received ribavirin with SOF/VEL/VOX, and 42% had pre-treatment resistance-associated substitution (RAS) testing performed. Eastern Mediterranean had a higher pooled SVR12 than the America and Europe regions (p < 0.05). Predictors of SOF/VEL/VOX failure were genotype 3, active HCC, baseline cirrhosis, and prior SOF/VEL. Baseline RAS mutation and ribavirin supplementation were not associated with higher SVR12. Treatment discontinuation because of drug-related adverse events was uncommon (10 studies, 0.2%). In summary, SOF/VEL/VOX is efficacious and safe for retreatment in DAA-experienced CHC patients, even with RAS mutation. Our findings support SOF/VEL/VOX as a first-line rescue treatment for DAA-experienced CHC patients.

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Section: Resultsmentioning

confidence: 99%

Treatment Outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir in Direct-Acting Antiviral-Experienced Hepatitis C Virus Patients: A Systematic Review and Meta-Analysis

Devan,

Tiong,

Neo

et al. 2023

Viruses

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“…Given the frequency of baseline NS5A RASs in naive patients (8.9-15.8%) and the emergence of NS5A RASs in patients who fail treatment with NS5A inhibitors (80-90%), it is clear why current retreatment regimens recommend the addition of ribavirin [19,20]. It should be noted that the above is more relevant to retreatment regimens that include SOF/VEL±RIB, since the results of retreatment with SOF/VEL/VOX±RIB and SOF+GLE/PIB±RIB are less dependent on the addition of RIB [39,40]. In recent years, a number of studies have appeared on the e cacy of 16-24 week regimens of SOF+GLE/PIB+RIB in a group of patients infected with HCV genotype 3 who had failed treatment with SOF/VEL/VOX.…”

Section: Discussionmentioning

confidence: 99%

Retreatment of patients with chronic hepatitis C, subtype 3a, and cirrhosis, who previously failed a regimen containing second-generation NS5A inhibitors with sofosbuvir + glecaprevir/pibrentasvir and ribavirin for 16-24 weeks

Fedorchenko,

Klimenko,

Martynovych

et al. 2024

Preprint

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Background: The use of direct acting antiviral agents (DAAs) in patients with chronic HCV genotype (GT) 3a infection results in sustained virologic response (SVR) rates of 93-98%, but 3-6% of patients experience virologic failure. Methods: We observed 11 patients infected with HCV subtype 3a who failed previous treatment with DAAs, with liver cirrhosis. All patients previously failed with sofosbuvir+velpatasvir+ribavirin for 24 weeks. Patients received retreatment with sofosbuvir, glecaprevir/pibrentasvir and ribavirin for 16-24 weeks. We compared SVR12 rates depending on the presence of NS5A mutation (L31M, A30K, Y93H or double mutations). Results: Observed SVR12 rate was: 100% (11/11 patients) overall. Conclusion:s Retreatment with SOF+GLE/PIB+RBV for 16-24 weeks was highly effective and safe in patients with chronic HCV GT3a infection, including those with liver cirrhosis, who previously failed DAA containing second-generation NS5A inhibitors. Presence of NS5A RASs L31M, A30K, Y93H or double mutations at the baseline did not impact SVR12 rates.

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Effectiveness and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir as a Hepatitis C Virus Infection Salvage Therapy in the Real World: A Systematic Review and Meta-analysis

Xie

Wei

et al. 2022

Infect Dis Ther

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Introduction: Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) is the first direct-acting antiviral (DAA) therapy approved for patients who have previously failed a DAA-containing regimen including NS5A inhibitors. In clinical trials, SOF/VEL/VOX was associated with high rates of sustained virologic response at posttreatment week 12 (SVR12) and was well tolerated. However, the effectiveness and safety of SOF/VEL/VOX in the real world remained uncertain. We aimed to perform a systematic review and meta-analysis to assess the real world effectiveness and safety of SOF/VEL/VOX. Methods: We systematically searched the PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases for relevant real world studies published before January 28, 2022. Patients with previous treatment failure who received SOF/VEL/VOX were included. The primary outcome was the

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THU-142-Sofosbuvir + velpatasvir + voxilaprevir in DAA failure patients with cirrhosis: Final results of the French compassionate use program

Cited by 5 publications

References 0 publications

Treatment Outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir in Direct-Acting Antiviral-Experienced Hepatitis C Virus Patients: A Systematic Review and Meta-Analysis

Treatment Outcomes of Sofosbuvir/Velpatasvir/Voxilaprevir in Direct-Acting Antiviral-Experienced Hepatitis C Virus Patients: A Systematic Review and Meta-Analysis

Retreatment of patients with chronic hepatitis C, subtype 3a, and cirrhosis, who previously failed a regimen containing second-generation NS5A inhibitors with sofosbuvir + glecaprevir/pibrentasvir and ribavirin for 16-24 weeks

Effectiveness and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir as a Hepatitis C Virus Infection Salvage Therapy in the Real World: A Systematic Review and Meta-analysis

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