Trial reportHepatology (Baltimore, Md.)2015
All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study.
Trial report in Hepatology (Baltimore, Md.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02032901 (A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection), which is not on this map. Cited by 254 papers, 9 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
Who cites it
254 citing papers in PubMed, 9 syntheses or guidelines pooled it.
- Prevalence of Drug Resistance Associated Substitutions in Persons With Chronic Hepatitis C Infection and Virological Failure Following Initial or Re-treatment With Pan-genotypic Direct-Acting Antivirals: A Systematic Review and Meta-analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Pooled it
- 2017 KASL clinical practice guidelines management of hepatitis C: Treatment of chronic hepatitis C.Clinical and molecular hepatology · 2018Guideline
- Recommendations for the treatment of hepatitis C virus infection in chronic kidney disease: a position statement by the Spanish association of the liver and the kidney.Journal of nephrology · 2018Guideline
- Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review.Annals of internal medicine · 2017Pooled it
- APASL consensus statements and recommendations for hepatitis C prevention, epidemiology, and laboratory testing.Hepatology international · 2016Guideline
- SASLT guidelines: Update in treatment of Hepatitis C virus infection.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2016Guideline
- Hepatitis C virus genotype 3: Meta-analysis on sustained virologic response rates with currently available treatment options.World journal of gastroenterology · 2016Pooled it
- HCV Council--critical appraisal of data: recommendations for clinical practice in a rapidly evolving therapeutic landscape.Liver international : official journal of the International Association for the Study of the Liver · 2016Guideline
- KASL clinical practice guidelines: management of hepatitis C.Clinical and molecular hepatology · 2016Guideline
- Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial.The lancet. Gastroenterology & hepatology · 2021Trial
- Glecaprevir/Pibrentasvir in patients with chronic HCV genotype 3 infection: An integrated phase 2/3 analysis.Journal of viral hepatitis · 2019Trial
- A prospective study of daclatasvir and sofosbuvir in chronic HCV-infected kidney transplant recipients.BMC nephrology · 2019Trial
- Trial
- Glecaprevir/pibrentasvir for hepatitis C virus genotype 3 patients with cirrhosis and/or prior treatment experience: A partially randomized phase 3 clinical trial.Hepatology (Baltimore, Md.) · 2018Trial
- Hepatitis C virus testing for case identification in persons born during 1945-1965: Results from three randomized controlled trials.Hepatology (Baltimore, Md.) · 2018Trial
- The effectiveness of daclatasvir based therapy in European patients with chronic hepatitis C and advanced liver disease.BMC infectious diseases · 2017Trial
- Ribavirin-Free Regimen With Sofosbuvir and Velpatasvir Is Associated With High Efficacy and Improvement of Patient-Reported Outcomes in Patients With Genotypes 2 and 3 Chronic Hepatitis C: Results From Astral-2 and -3 Clinical Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Trial
- High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection.Liver international : official journal of the International Association for the Study of the Liver · 2016Trial
- Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence.Hepatology (Baltimore, Md.) · 2016Trial
- Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).Hepatology (Baltimore, Md.) · 2016Trial
194 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
26 authors.
Funding
Abstract
unlabelledTreatment options for patients with hepatitis C virus (HCV) genotype 3 infection are limited, with the currently approved all-oral regimens requiring 24-week treatment and the addition of ribavirin (RBV). This phase III study (ALLY-3; ClinicalTrials.gov: NCT02032901) evaluated the 12-week regimen of daclatasvir (DCV; pangenotypic nonstructural protein [NS]5A inhibitor) plus sofosbuvir (SOF; pangenotypic NS5B inhibitor) in patients infected with genotype 3. Patients were either treatment naïve (n = 101) or treatment experienced (n = 51) and received DCV 60 mg plus SOF 400 mg once-daily for 12 weeks. Coprimary endpoints were the proportions of treatment-naïve and treatment-experienced patients achieving a sustained virological response (SVR) at post-treatment week 12 (SVR12). SVR12 rates were 90% (91 of 101) and 86% (44 of 51) in treatment-naïve and treatment-experienced patients, respectively; no virological breakthrough was observed, and ≥99% of patients had a virological response (VR) at the end of treatment. SVR12 rates were higher in patients without cirrhosis (96%; 105 of 109) than in those with cirrhosis (63%; 20 of 32). Five of seven patients who previously failed treatment with an SOF-containing regimen and 2 of 2 who previously failed treatment with an alisporivir-containing regimen achieved SVR12. Baseline characteristics, including gender, age, HCV-RNA levels, and interleukin-28B genotype, did not impact virological outcome. DCV plus SOF was well tolerated; there were no adverse events (AEs) leading to discontinuation and only 1 serious AE on-treatment, which was unrelated to study medications. The few treatment-emergent grade 3/4 laboratory abnormalities that were observed were transient.
conclusionA 12-week regimen of DCV plus SOF achieved SVR12 in 96% of patients with genotype 3 infection without cirrhosis and was well tolerated. Additional evaluation to optimize efficacy in genotype 3-infected patients with cirrhosis is underway.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.