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Official Title Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection
Purpose / DescriptionThis open-label phase 2a trial enrolled 211 subjects from 18 centers in the United States. In part 1 of the trial, investigators initially enrolled 88 treatment-naive patients (44 with genotype 1 and 44 with genotype 2 or 3) to receive the interferon-free regimen of daclatasvir 60 mg once daily with sofosbuvir 400 mg once daily, with or without weight-based ribavirin for 24 weeks; one of the study arms that did not include ribavirin had a 7-day lead-in with sofosbuvir alone. The study later expanded (part 2 ) to include an additional 123 patients with genotype (GT) 1 randomly assigned to a course of daclatasvir plus sofosbuvir, with or without ribavirin for 12 weeks (for 82 treatment naive patients) or 24 weeks (for 41 who had prior treatment failure with telaprevir or boceprevir-based regimens). The SVR12 was 98% for the 126 treatment-naive GT1 patients and 98% for the 41 prior non-responders; 92% of the 26 GT2 patients and 89% of the 18 GT3 patients achieved an SVR12. Response rates did not vary by genotype 1 subtype, treatment duration, presence of ribavirin, or IL28B status. Both medications were generally well-tolerated; the most common adverse effects were fatigue (37%), headache (29%) and nausea (19%) with similar frequency between the treatment groups with or without ribavirin.
Phase Phase II
ClinicalTrials.gov NCT01359644
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb; Pharmasset (Gilead Sciences)
References
- Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370:211-21.
Official Title Daclatasvir with Sofosbuvir and Ribavirin for Hepatitis C Virus Infection with Advanced Cirrhosis or Post-Liver Transplantation Recurrence
Purpose / DescriptionThis open-label study enrolled 60 patients with advanced cirrhosis (Child-Pugh class distribution 20% A, 53% B and 27% C) and 53 patients with post-liver transplant HCV recurrence; both groups received a 12-week course of daclatasvir plus sofosbuvir plus ribavirin (initial dose 600 mg daily and then adjusted up to 1000 mg/day as tolerated based on hemoglobin levels and renal function). Genotypes 1, 2, 3, 4 and 6 were represented; the majority (76%) were genotype 1 and 15% had genotype 3. The overall SVR12 rates were 83% among advanced cirrhotics, with subanalysis by Child Pugh class showing SVR12 rates of 92% with class A, 94% with class B, and 56% with class C. The SVR12 rate was 94% among post-transplant patients. Among genotype 3 patients, 88% (15 of 17) achieved SVR12. The combination was well tolerated with no serious treatment-related adverse events.
Phase Phase III
ClinicalTrials.gov NCT02032875
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Poordad F, Schiff ER, Vierling JM, et al. Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post-liver transplantation recurrence. Hepatology. 2016;63:1493-505.
Official Title Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1
Purpose / DescriptionIn this phase 3, open-label trial, patients with HCV genotype 1 through 4 and HIV confection were treated with daclatasvir and sofosbuvir. Previously untreated patients received either an 8-week or 12-week course, whereas treatment-experienced patients were treated with a 12-week course. Patients with cirrhosis were allowed in the enrollment and comprised 10% and 29% of treatment-naive and experienced groups respectively. Overall, 168 (83%) of 203 patients had genotype 1 infection. Among treatment-naive patients, the SVR12 rates were 97% in the 12-week group and 76% in the 8-week group. For the treatment-experienced patients, all of whom received therapy for 12 weeks, the SVR12 rate was 98%.
Phase Phase III
ClinicalTrials.gov NCT02032888
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:714-25.
Official Title All-Oral 12-Week Treatment with Daclatasvir plus Sofosbuvir in Patients with Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase III Study
Purpose / DescriptionIn this parallel-arm phase 3 trial, investigators assigned 101 treatment-naive genotype 3 patients and 51 treatment-experienced genotype 3 patients to a 12-week all-oral regimen of daclatasvir 60 mg once daily and sofosbuvir 400 mg once daily. Cirrhotic patients comprised 19% and 25% of these groups respectively. An SVR12 was achieved in 90% of treatment-naive and 86% of treatment-experienced GT 3 patients, with viral relapse responsible for nearly all the treatment failures. The presence of cirrhosis was associated with a lower SVR12 rate at 63% overall, regardless of treatment experience. This combination was generally safe and well tolerated with the most frequent adverse events being headache, fatigue and nausea.
Phase Phase III
ClinicalTrials.gov NCT02032901
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Nelson DR, Cooper JN, Lalezari JP, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61:1127-35.
Official Title Daclatasvir, Sofosbuvir, and Ribavirin for Hepatitis C Virus Genotype 3 and Advanced Liver Disease: A Randomized Phase III study (ALLY-3+)
Purpose / DescriptionIn this phase 3, open-label, randomized controlled trial, 50 patients (13 treatment-naive and 37 treatment-experienced) with genotype 3 HCV infection and either stage 3 or 4 fibrosis were randomized 1:1 to sofosbuvir plus daclatasvir plus ribavirin (weight-based dosing) for either 12 or 16 weeks. The overall SVR12 rates were 90% for all patients, and 88% and 92% for patients in the 12-week and 16-week arms respectively. All patients with stage 3 fibrosis achieved SVR, compared with 86% (31 of 36) cirrhotic patients. Treatment experience did not appear to influence SVR12 rates.
Phase Phase III
ClinicalTrials.gov NCT02319031
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Leroy V, Angus P, Bronowicki JP, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+). Hepatology. 2016;63:1430-41.
Official Title Daclatasvir plus Peginterferon Alfa and Ribavirin for Treatment-Naive Chronic Hepatitis C Genotype 1 or 4 Infection: A Randomised Study
Purpose / DescriptionIn this phase 2b randomized, double-blinded, placebo-controlled trial, investigators enrolled treatment-naive patients with HCV genotype 1 or 4 to receive daclatasvir (or placebo) plus peginterferon and ribavirin. The study design consisted of three main arms: peginterferon and ribavirin plus (a) daclatasvir 20 mg, (b) daclatasvir 60 mg, or (c) placebo. In addition, patients in the daclatasvir groups were stratified at week 12 based on HCV RNA levels at weeks 4 and 10; those patients with a a protocol-defined response (HCV RNA less than lower limit of quantitation at week 4 and undetectable at week 1) then were re-randomized to receive an additional 12 weeks of either daclatasvir or placebo, in combination with peginterferon and ribavirin; patients who did not have a protocol-defined response all received placebo with peginterferon for 12 weeks, followed by an additional 24 weeks of peginterferon and ribavirin. Those enrolled in the original placebo group received peginterferon and ribavirin for 48 weeks, with receipt of placebo during the first 24 weeks. Overall, for genotype 1, the SVR12 rates were 65% in the daclatasvir 20 mg arm (95/147), 90% in the 60 mg arm (88/146), and 36% (26/72) in the placebo arm. Among the patients with genotype 4, the SVR12 rates were were 75% (9/12) in the daclatasvir 20 mg arm, 100% (12/12) in the 60 mg arm, and 50% (3/6) in the placebo arm. For patients with genotype 1 HCV, the regimen of daclatasvir with peginterferon and ribavirin was only moderately effective. For patients with genotype 4 HCV, the findings from the relatively small numbers of patients in this study suggest daclatasvir with peginterferon and ribavirin is effective, particularly with the 60 mg dose of daclatasvir.
Phase Phase II
ClinicalTrials.gov NCT01125189
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Hézode C, Hirschfield GM, Ghesquiere W, et al. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015;64:948-56.
Official Title Randomized Controlled Trial of the NS5A Inhibitor Daclatasvir plus Pegylated Interferon and Ribavirin for HCV Genotype-4 (COMMAND-4)
Purpose / DescriptionThis phase 3 trial randomized 124 treatment-naive patients with genotype 4 HCV infection, in a 2:1 ratio, to daclatasvir versus placebo combined with peginterferon and ribavirin. The treatment arm had a response-guided strategy that permitted the cessation of therapy at 24 weeks if patients achieved an undetectable HCV RNA at week 4 and 12; the remainder and the placebo arm received a total of 48 weeks of peginterferon plus ribavirin. Most (79%) of the daclatasvir plus peginterferon plus ribavirin group had extended rapid virologic responses allowing 24-week duration. The SVR12 rates were 82% for the daclatasvir arm versus 43% for the placebo arm. There was no significant differences in the safety profile between the daclatasvir plus peginterferon plus ribavirin arm versus the control arm (peginterferon plus ribavirin).
Phase Phase III
ClinicalTrials.gov NCT01448044
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Hézode C, Alric L, Brown A, et al. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015;21:195-205.
Official Title All-Oral Daclatasvir plus Asunaprevir for Hepatitis C Virus Genotype 1b: A Multinational, Phase 3, Multicohort Study
Purpose / DescriptionThis was a phase 3 multi-cohort study that enrolled patients from 18 countries, all with genotype 1b HCV infection. The first cohort included 307 treatment-naive patients who were randomized in a 2:1 ratio to receive either daclatasvir 60 mg once daily plus the investigational drug asunaprevir 100 mg twice daily for 24 weeks versus placebo—a comparison designed to evaluate safety and tolerability. The second and third cohorts of the study assigned 205 treatment-experienced patients with GT1b infection with prior non-response to peginterferon plus ribavirin (partial or null responders) and 235 patients ineligible and/or intolerant to peginterferon to 24 weeks of daclatasvir 60 mg once daily plus asunaprevir 100 mg twice daily. The SVR12 rates were 91% for the treatment-naive cohort, 82% for the non-responder cohort, and 83% for the ineligible/intolerant cohort. The most common adverse events (occurring in 10% or more in any cohort) were headache, fatigue, nausea and asthenia. There were few discontinuations due to adverse events.
Phase Phase III
ClinicalTrials.gov NCT01581203
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Manns M, Pol S, Jacobson IM, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014;384:1597-605.
Official Title Daclatasvir and Asunaprevir plus Peginterferon Alfa and Ribavirin in HCV Genotype 1 or 4 Non-Responders
Purpose / DescriptionThis open-label phase 3 study that enrolled treatment-experienced patients with genotype 1 or 4 infection who were prior null or partial responders to peginterferon and ribavirin to receive a 24-week course of daclatasvir, the asunaprevir (investigational), peginterferon, and ribavirin. With this treatment regimen, SVR12 was achieved in 329 (93%) of 354 patients with HCV genotype 1 infection, including SVR12 rates of 153 (87%) of 176 patients with GT 1a and 176 (99%) of 178 with genotype 1b. In addition, SVR12 was achieved in 43 (98%) of 44 patients with HCV genotype 4. Prior response to treatment with peginterferon and ribavirin, cirrhosis, or IL28B status did not significantly influence SVR12 response rates. The most commonly reported adverse events were fatigue, headache, pruritus, asthenia, and influenza-like syndrome without safety or tolerability concerns independent of those historically observed with peginterferon plus ribavirin.
Phase Phase III
ClinicalTrials.gov NCT01573351
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Jensen D, Sherman KE, Hézode C, et al. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015;63:30-7.
Official Title Fixed-Dose Combination Therapy with Daclatasvir, Asunaprevir, and Beclabuvir for Noncirrhotic Patients with HCV Genotype 1 Infection
Purpose / DescriptionIn this open-label, randomized, phase3, multi-center, international trial, investigators examined the safety and efficacy of the fixed dose combination of daclatasvir-asunaprevir-beclabuvir (investigational) for 12 weeks in 415 patients with genotype 1 HCV infection without cirrhosis. The trial included treatment-naïve and treatment-experienced patients; all subjects received 12 weeks of therapy. Overall, 379 (91%) of 415 patients achieved an SVR12, including and SVR 12 in 92% in treatment naïve patients and 89% in treatment-experienced patients. This regimen appeared to be safe and well tolerated in this group of cirrhotic patients. The most common adverse events were headache, fatigue, diarrhea, and nausea.
Phase Phase III
ClinicalTrials.gov NCT01979939
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Poordad F, Sievert W, Mollison L, et al. Fixed-dose combination therapy with daclatasvir, asunaprevir, and beclabuvir for noncirrhotic patients with HCV genotype 1 infection. JAMA. 2015;313:1728-35.
Official Title Daclatasvir in Combination with Asunaprevir and Beclabuvir for Hepatitis C Virus Genotype 1 Infection with Compensated Cirrhosis
Purpose / DescriptionThis multi-center, randomized, double-blind, phase 3 study examined the safety and efficacy of the fixed dose combination of daclatasvir-asunaprevir-beclabuvir, with or without ribavirin, in 202 patients with genotype 1 HCV infection and compensated (Child-Pugh class A) cirrhosis. The trial included treatment-naïve and treatment-experienced patients; all subjects received 12 weeks of therapy. A high SVR12 rate was observed in all treatment groups, with a trend toward slightly higher rates in treatment-naive (93 to 98%) compared with treatment-experienced (87 to 93%) patients. Viral relapse was the most common cause of treatment failure and occurred more frequently in the ribavirin-free arms. This FDC appeared to be safe and well tolerated in this group of cirrhotic patients. Adverse events including fatigue, headache and anemia, were more common in the ribavirin-containing arms.
Phase Phase III
ClinicalTrials.gov NCT01973049
Treatments
Daclatasvir![Daclatasvir Daklinza](//cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
![Daclatasvir Daklinza](http://cdn.hepatitisc.uw.edu/css/images/drugs/10.png)
Daclatasvir
Tradename:DaklinzaOther Names:DCVClass:DiscontinuedFunding
IndustryBristol-Myers Squibb
References
- Muir AJ, Poordad F, Lalezari J, et al. Daclatasvir in combination with asunaprevir and beclabuvir for hepatitis C virus genotype 1 infection with compensated cirrhosis. JAMA. 2015;313:1736-44.
Editor's Summary
A PDF version of this treatment drug's summary, including the clinical trial descriptions and references.
Daclatasvir Slide Deck
August 9, 2017
Clinical Trial Image Decks
AI444040 - August 9, 2017
ALLY-1 - August 9, 2017
ALLY-2 - August 9, 2017
ALLY-3 - August 9, 2017
ALLY-3+ - August 9, 2017
COMMAND-1 - August 9, 2017
COMMAND-4 - August 9, 2017
HALLMARK-DUAL - August 9, 2017
HALLMARK-QUAD - August 9, 2017
UNITY-1 - August 9, 2017
UNITY-2 - August 9, 2017