MedPath

Dasabuvir

Generic Name
Dasabuvir
Brand Names
Exviera, Viekira Pak
Drug Type
Small Molecule
Chemical Formula
C26H27N3O5S
CAS Number
1132935-63-7
Unique Ingredient Identifier
DE54EQW8T1
Background

Dasabuvir is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients . Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as Dasabuvir. Dasabuvir is a non-nucleoside NS5B inhibitor which binds to the palm domain of NS5B and induces a conformational change which renders the polymerase unable to elongate viral RNA . The binding sites for non-nucleoside NS5B inhibitors are poorly conserved across HCV genotypes leading to the restriction of Dasabuvir's use to genotype 1 only.

In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend Dasabuvir as first line therapy in combination with Ombitasvir, Paritaprevir, and Ritonavir for genotype 1b and with Ribavirin for genotype 1a of Hepatitis C . Dasabuvir, Ombitasvir, Paritaprevir, Ritonavir, and Ribavirin are used with the intent to cure, or achieve a sustained virologic response (SVR), after 12 weeks of therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality .

Dasabuvir is available as a fixed dose combination product with Ombitasvir, Paritaprevir, and Ritonavir (tradename Viekira Pak) used for the treatment of chronic Hepatitis C. Approved in December 2014 by the FDA, Viekira Pak is indicated for the treatment of HCV genotype 1a with Ribavirin or genotype 1b without Ribavirin . When combined together, Dasabuvir Ombitasvir, Paritaprevir, and Ritonavir as the combination product Viekira Pak have been shown to achieve a SVR of 100% for genotype 1b and 89% or 95% for genotype 1a after 12 weeks or 24 weeks of treatment including Ribavirin.

Indication

Dasabuvir, in combination with Ombitasvir, Paritaprevir, and Ritonavir (as Viekira Pak) is indicated for the treatment of patients with HCV genotype 1a with Ribavirin or genotype 1b without Ribavirin including those with compensated cirrhosis .

Associated Conditions
Chronic hepatitis C genotype 1a, Chronic hepatitis C genotype 1b
Associated Therapies
-

Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.

Phase 4
Conditions
Chronic Hepatitis, C Virus
Interventions
Drug: Ombitasvir-Paritaprevir-Ritonavir
Drug: Dasabuvir
Drug: Ribavirin
First Posted Date
2016-11-01
Last Posted Date
2016-11-01
Lead Sponsor
University of Modena and Reggio Emilia
Target Recruit Count
75
Registration Number
NCT02950870
Locations
🇮🇹

Gastroenterology Unit, Modena, Italy

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2016-06-16
Last Posted Date
2019-10-11
Lead Sponsor
AbbVie
Target Recruit Count
256
Registration Number
NCT02803138
Locations
🇮🇱

Ha'Emek Medical Center /ID# 153695, Afula, Israel

🇮🇱

Assaf Harofeh Medical Center /ID# 153708, Be'er Ya'akov, Israel

🇮🇱

The Edith Wolfson Medical Cent /ID# 153706, Holon, Israel

and more 15 locations

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C

Completed
Conditions
Chronic Hepatitis C
Interventions
Drug: Paritaprevir/ritonavir/ombitasvir
Drug: Dasabuvir
Drug: Ribavirin
First Posted Date
2016-04-01
Last Posted Date
2019-03-15
Lead Sponsor
AbbVie
Target Recruit Count
216
Registration Number
NCT02725866

Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

Phase 3
Completed
Conditions
Hepatitis C, Acute
Interventions
Drug: Paritaprevir/ritonavir/ombitasvir
Drug: Glecaprevir/pibrentasvir
Drug: Dasabuvir
Drug: Ribavirin
First Posted Date
2015-12-17
Last Posted Date
2022-08-22
Lead Sponsor
Kirby Institute
Target Recruit Count
83
Registration Number
NCT02634008
Locations
🇦🇺

Royal Adelaide Hospital, Adelaide, South Australia, Australia

🇦🇺

St Vincent's Hospital, Sydney, New South Wales, Australia

🇬🇧

Pennine Acute Hospital, Manchester, United Kingdom

and more 8 locations

The Effectiveness of ABT-450/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C -An Observational Study in Ireland

Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2015-10-21
Last Posted Date
2019-05-06
Lead Sponsor
AbbVie
Target Recruit Count
101
Registration Number
NCT02582671

A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults

Phase 3
Completed
Conditions
Hepatitis C Infection
Hepatitis C Virus
Interventions
First Posted Date
2015-10-21
Last Posted Date
2021-07-30
Lead Sponsor
AbbVie
Target Recruit Count
166
Registration Number
NCT02582632

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada

Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2015-10-20
Last Posted Date
2019-03-27
Lead Sponsor
AbbVie
Target Recruit Count
565
Registration Number
NCT02581189

Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium

Completed
Conditions
Chronic Hepatitis C, Genotype 1 or 4
Interventions
First Posted Date
2015-10-20
Last Posted Date
2019-05-06
Lead Sponsor
AbbVie
Target Recruit Count
314
Registration Number
NCT02581163

Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults

Phase 2
Completed
Conditions
Hepatitis C (HCV)
Hepatitis C Genotype 1a
Chronic Hepatitis C
Interventions
Drug: Ombitasvir/ABT-450/Ritonavir
Drug: Dasabuvir
Drug: Ribavirin (RBV)
First Posted Date
2015-07-10
Last Posted Date
2017-10-31
Lead Sponsor
AbbVie
Target Recruit Count
46
Registration Number
NCT02493855

A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

First Posted Date
2015-07-01
Last Posted Date
2021-10-05
Lead Sponsor
AbbVie
Target Recruit Count
64
Registration Number
NCT02486406
Locations
🇵🇷

San Jorge Children Hospital /ID# 136832, San Juan, Puerto Rico

🇺🇸

Seattle Children's Hospital /ID# 137019, Seattle, Washington, United States

🇩🇪

Helios Klinikum Wuppertal /ID# 142883, Wuppertal, Germany

and more 18 locations
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