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, Jing; Xu, Bin; Wei, Luqing; Huang, Chunyang; Liu, Wei

doi:10.1007/s40121-022-00666-0

Cited by 17 publications

(17 citation statements)

References 48 publications

(121 reference statements)

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“…The pangenotypic regimen SOF/VEL/ VOX represents a highly effective salvage therapy for patients who have experienced prior DAA failure. [5] Indeed, our data indicate that SOF/VEL/VOX efficacy does not decrease in the presence of PIB or VEL-induced NS5A-RASs, thus supporting its recommendation as re-treatment therapy. [10] However, the effectiveness of the triple-DAA regimen was challenged by the combination of SOF and VEL resistance, which is in agreement with studies reporting lower SOF/VEL/ VOX cure rates in SOF/VEL treatment-experienced patients.…”

Section: Discussionsupporting

confidence: 56%

“…[10] However, the effectiveness of the triple-DAA regimen was challenged by the combination of SOF and VEL resistance, which is in agreement with studies reporting lower SOF/VEL/ VOX cure rates in SOF/VEL treatment-experienced patients. [5] Thus, the addition of at least 2 new DAAs (and not only VOX) might be necessary for the retreatment of SOF/VEL treatment-experienced patients. In contrast, for GLE/PIB treatment-experienced patients, this triple salvage therapy might be sufficient.…”

Section: Discussionmentioning

confidence: 99%

“…[10] However, higher treatment failure rates are still reported for genotype 3 compared with other genotypes for all pangenotypic regimens. [3][4][5] Moreover, recent studies have shown that certain nonepidemic HCV genotypes that harbor natural polymorphisms conferring inherent resistance to NS5A inhibitors, such as genotype 3b, [11] might also be less responsive to pangenotypic regimens. [12] Success in re-treating patients with previous DAA treatment failure is crucial for preventing the persistence and spread of antiviral resistance.…”

Section: Introductionmentioning

confidence: 99%

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Characterization of multi-DAA resistance using a novel hepatitis C virus genotype 3a infectious culture system

et al. 2023

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Background and Aims: The high HCV infection cure rates achieved with direct-acting antiviral (DAA) treatments could be compromised in the future by the emergence of antiviral resistance. Thus, it is essential to understand the viral determinants that influence DAA resistance, which is most prevalent in genotype 3. We aimed at studying how resistance to protease-, NS5A-, and NS5Binhibitors influences the activities of glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir in cell culture, and how the HCV genome adapts to selective pressure by successive rounds of treatment failure.Approach and Results: A previously developed in vivo infectious cDNA clone of strain S52 (genotype 3a) was adapted to efficiently replicate and propagate in human hepatoma cells (Huh7.5) using 31 adaptive substitutions. DAA escape experiments resulted in the selection of S52 variants with decreased drug susceptibility (resistance), which was linked to the emergence of known resistance-associated substitutions (RASs). NS5A-inhibitor resistance was sufficient to promote treatment failure with double-DAA but not triple-DAA regimens. Enhanced viral fitness associated with the selection of sofosbuvir resistance accelerated escape from DAAs. After serial DAA treatment failure, HCV genetic evolution led to a complex genome-wide network of substitutions, some of which coevolved with known RASs. Conclusions: Baseline NS5A-RAS can compromise the efficacy of double-DAA pangenotypic regimens for HCV genotype 3, and enhanced viral fitness can accelerate treatment failure. Persistence of RASs after successive treatment failure is facilitated by the remarkable evolutionary capacity and plasticity of the HCV genome. Proof-of-concept for the potential development of multi-DAA resistance is shown.

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Section: Discussionsupporting

confidence: 56%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Characterization of multi-DAA resistance using a novel hepatitis C virus genotype 3a infectious culture system

et al. 2023

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“…In our study, all patients responded to SOF/VEL/VOX therapy, although data from a meta-analysis by Xie et al from a Canadian centre indicated that this option was less effective in patients previously treated with SOF/VEL [ 23 ]. The 12-week SOF/VEL/VOX therapy may be an effective option not only for patients with failed genotype-specific therapy, but also for those who failed to achieve SVR 12 on the pangenotypic GLE/PIB regimen.…”

Section: Discussionmentioning

confidence: 74%

“…The most common adverse event, reported by 10% of patients, was fatigue. Headaches, nausea, diarrhoea, and itchiness were reported in less than 2% of cases, while in other studies these numbers reached 4–10% [ 23 ]. Anaemia was reported in three of our patients, and in all cases was related to the selection of the therapeutic option with RBV.…”

Section: Discussionmentioning

confidence: 93%

Rescue Therapy after Failure of HCV Antiviral Treatment with Interferon-Free Regimens

Tronina

Brzdęk

Zarębska-Michaluk

et al. 2023

Viruses

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Direct-acting antivirals (DAA) regimens have provided hope for eliminating hepatitis C virus (HCV) infection. Patients following ineffective therapy with DAA, especially those previously treated with inhibitors of non-structural protein 5A (NS5A), remain a challenge. The study aimed to assess the effectiveness of DAA pangenotypic options in patients after failure of NS5A containing genotype-specific regimens. The analysis included 120 patients selected from the EpiTer-2 database with data on 15675 HCV-infected individuals treated with IFN-free therapies from 1 July 2015 to 30 June 2022 at 22 Polish hepatology centres. The majority of them were infected with genotype (GT) 1b (85.8%) and one-third was diagnosed with fibrosis F4. Among the rescue pangenotypic regimens, the most commonly used was the sofosbuvir/velpatasvir (SOF/VEL) ± ribavirin (RBV) combination. The sustained virologic response, which was a measure of treatment effectiveness, was achieved by 102 patients, resulting in cure rate of 90.3% in the per protocol analysis. All 11 non-responders were infected with GT1b, 7 were diagnosed with cirrhosis, and 9 were treated with SOF/VEL±RBV. We demonstrated the high effectiveness of the pangenotypic rescue options in patients after genotype specific NS5A-containing regimens failures, identifying cirrhosis as a negative prognostic factor of treatment effectiveness.

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Effects of comorbid conditions and prescribed chronic medications on the treatment plan for chronic hepatitis C infection: A cross‐sectional retrospective study

Awadh,

Badri,

Alansari

et al. 2024

Health Science Reports

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BackgroundChronic hepatitis C (CHC) infection is a potentially life‐threatening condition characterized by various complications, including end‐stage liver disease and cirrhosis. The mortality rate associated with CHC has been increasing due to the presence of comorbidities and the use of chronic medications. Therefore, the objective of this study was to investigate the impact of these comorbidities and chronic medications on the treatment plan for CHC.MethodsTo achieve this objective, a cross‐sectional retrospective study was conducted at a tertiary hospital in Jeddah, Saudi Arabia. The study population included patients aged 12 years and above who were diagnosed with CHC between 2016 and 2021. Patients below the age of 12 were excluded from the study. A total of 170 patients with CHC were included in the analysis. The study aimed to evaluate the relationship between CHC complications and the treatment approach.ResultsThe mean age of the study participants was 66.78 years, with a higher proportion of female patients. The findings revealed a significant association between hypertension (p = 0.042) and cirrhosis (p = 0.007) with changes in the treatment plan for CHC. Moreover, the presence of diabetes mellitus (p = 0.045), renal diseases (p < 0.001), and hypothyroidism (p = 0.004) were significantly associated with HCV clearance after the initiation of therapy. Additionally, the use of proton pump inhibitors (p = 0.033) and levothyroxine (p = 0.025) was found to be associated with a higher rate of CHC clearance.ConclusionIn conclusion, this study highlights the prevalence of comorbid conditions and the use of chronic medications among patients with CHC. The findings emphasize the importance of considering the effects of comorbidities and chronic medications when developing treatment plans for CHC infections. By taking these factors into account, healthcare professionals can optimize the management of CHC and improve patient outcomes.

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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

Cited by 17 publications

References 48 publications

Characterization of multi-DAA resistance using a novel hepatitis C virus genotype 3a infectious culture system

Characterization of multi-DAA resistance using a novel hepatitis C virus genotype 3a infectious culture system

Rescue Therapy after Failure of HCV Antiviral Treatment with Interferon-Free Regimens

Effects of comorbid conditions and prescribed chronic medications on the treatment plan for chronic hepatitis C infection: A cross‐sectional retrospective study

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