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
-

Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults

Phase 3
Completed
Conditions
Hepatitis C Genotype 1a
Chronic Hepatitis C
Hepatitis C (HCV)
Interventions
First Posted Date
2015-06-19
Last Posted Date
2017-10-03
Lead Sponsor
AbbVie
Target Recruit Count
25
Registration Number
NCT02476617

Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment

Phase 4
Active, not recruiting
Conditions
Hepatitis C Virus
Interventions
First Posted Date
2015-06-02
Last Posted Date
2024-08-23
Lead Sponsor
Nova Scotia Health Authority
Target Recruit Count
44
Registration Number
NCT02460133

Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions

First Posted Date
2015-01-07
Last Posted Date
2022-06-29
Lead Sponsor
Valme University Hospital
Target Recruit Count
1128
Registration Number
NCT02333292
Locations
🇪🇸

Valme University Hospital, Seville, Andalusia, Spain

A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

Phase 3
Completed
Conditions
Chronic Hepatitis C Infection
Compensated Cirrhosis
Interventions
First Posted Date
2014-08-19
Last Posted Date
2021-07-12
Lead Sponsor
AbbVie
Target Recruit Count
60
Registration Number
NCT02219503

A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection

Phase 3
Completed
Conditions
Chronic Hepatitis C Virus (HCV) Infection
Interventions
First Posted Date
2014-08-15
Last Posted Date
2016-06-29
Lead Sponsor
AbbVie
Target Recruit Count
36
Registration Number
NCT02216422

Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

Phase 3
Completed
Conditions
Hepatitis C Virus
Compensated Cirrhosis
End-stage Renal Disease
Chronic Hepatitis C
Severe Renal Impairment
Interventions
First Posted Date
2014-08-01
Last Posted Date
2017-11-09
Lead Sponsor
AbbVie
Target Recruit Count
68
Registration Number
NCT02207088

Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy

Phase 2
Terminated
Conditions
Hepatitis C
HIV Infections
Interventions
Drug: Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)
Drug: Dasabuvir (DSV)
Drug: Ribavirin (RBV)
First Posted Date
2014-07-21
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
46
Registration Number
NCT02194998
Locations
🇺🇸

University of Washington AIDS CRS, Seattle, Washington, United States

🇺🇸

UCLA CARE Center CRS, Los Angeles, California, United States

🇺🇸

Cincinnati Clinical Research Site, Cincinnati, Ohio, United States

and more 13 locations
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