Ribavirin

Generic Name
Ribavirin
Brand Names
Ibavyr, Rebetol, Virazole
Drug Type
Small Molecule
Chemical Formula
C8H12N4O5
CAS Number
36791-04-5
Unique Ingredient Identifier
49717AWG6K
Background

Producing a broad-spectrum activity against several RNA and DNA viruses, Ribavirin is a synthetic guanosine nucleoside and antiviral agent that interferes with the synthesis of viral mRNA. It is primarily indicated for use in treating hepatitis C and viral hemorrhagic fevers. 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 . It is reported that ribavirin might be only effective in early stages of viral hemorrhagic fevers including Lasser fever, Crimean-Congo hemorrhagic fever, Venezuelan hemorrhagic fever, and Hantavirus infection. Ribavirin is a prodrug that is metabolized into nucleoside analogs that blocks viral RNA synthesis and viral mRNA capping. Before the development of newer drugs, ribavirin and Peginterferon alfa-2a/Peginterferon alfa-2b dual therapy was considered the first-generation and standard antiviral treatment . The dual therapy was administered for 48 weeks in patients with genotype 1, 4, 5, and 6, and 24 weeks in patients with genotype 2 and 3 . Newer drugs developed as Hepatitis C viral infection treatments can be used to reduce or eliminate the use of ribavirin, which are associated with serious adverse effects. They also improve therapeutic efficacy in patients with failed Peginterferon alfa-2a/Peginterferon alfa-2b and ribavirin-based therapy. The potential use of ribavirin as a treatment for acute myeloid leukemia is currently under investigation.

According to 2017 American Association for the Study of Liver Diseases (AASLD) and 2015 consensus guidelines from the Canadian Association for the Study of the Liver (CASL), ribavirin is typically used as an adjunct therapy to various first-line and second-line combination therapies recommended for each genotypes. Ribavirin is added to decrease relapse rates by accelerating viral clearance early in the treatment course . When used to treat Hepatitis C virus (HCV) infections, it is always used as a part of combination therapies as ribavirin monotherapy is not efficacious in the treatment of chronic hepatitis C infection . Additionally, including ribavirin in the regimen can increase the risk of anemia.

In HCV genotye 1/2/3/4/5/6 patients, ribavirin can be used in combination therapy involving Daclatasvir and Sofosbuvir, Eplusa (Sofosbuvir, Velpatasvir), Harvoni (Sofosbuvir, Ledipasvir), Simeprevir and Sofosbuvir, Viekira Pak (Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir), Technivie (Ritonavir, Ombitasvir, Paritaprevir) and Zepatier (Elbasvir, Grazoprevir). Addition of weight-based ribavirin to Technivie therapy increased sustained virologic response after 12 weeks of daily therapy (SVR12) from 90% to 97% in patients with HCV genotype 1a and 90.9% to 100% in HCV genotype 4 patients . Zepatier therapy along with ribavirin improved SVR in HCV genotype 5 patients. Combination therapy of ribavirin and Peginterferon alfa-2a results in the SVR of 44% in patients with genotype 1 infection and 70% in patients with genotype 2-6. The inclusion of ribavirin in the combination therapies depend on individual patient's profile, for example if HCV genotype 3 patient has a Y93H genetic variant and compensated cirrhosis.

Indication

Indicated for the treatment of chronic Hepatitis C virus (HCV) infection in combination with other antiviral agents with the intent to cure or achieve a sustained virologic response (SVR). Typically added to improve SVR and reduce relapse rates .

The addition of ribavirin in Technivie therapy indicated for treating HCV genotype 1a and 4 infections is recommended in patients with or without cirrhosis.

Resistance: viral genetic determinants resulting in variable response to ribavirin therapy has not been yet determined.

Associated Conditions
Chronic Hepatitis C Virus (HCV) Infection, Severe Respiratory Syncytial Virus Infection
Associated Therapies
-

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

First Posted Date
2007-05-17
Last Posted Date
2016-11-01
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
14
Registration Number
NCT00475072

Ribavirin/Pegasys Treatment of Recurrent Hepatitis C After Liver Transplant

Phase 3
Completed
Conditions
First Posted Date
2007-04-27
Last Posted Date
2007-04-27
Lead Sponsor
University Hospital, Geneva
Target Recruit Count
25
Registration Number
NCT00466219

Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2007-03-12
Last Posted Date
2012-07-27
Lead Sponsor
Bausch Health Americas, Inc.
Target Recruit Count
278
Registration Number
NCT00446134
Locations
🇺🇸

Cedars-Sinai Medical Center, 8635 W. 3rd Street, Suite 590W, Los Angeles, California, United States

Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy

First Posted Date
2007-02-21
Last Posted Date
2009-02-06
Lead Sponsor
IRCCS San Raffaele
Target Recruit Count
60
Registration Number
NCT00437476
Locations
🇮🇹

San Raffaele Hospital Dep. Infectious Diseases, Milan, Italy

Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Patients Starting Treatment With Anti-Hepatitis C Virus (HCV) Therapy

First Posted Date
2007-02-21
Last Posted Date
2009-02-06
Lead Sponsor
IRCCS San Raffaele
Target Recruit Count
50
Registration Number
NCT00437684
Locations
🇮🇹

San Raffaele Hospital, Dep. Infectious Diseases, Milan, Italy

Retreatment of Chronic Hepatitis C Non-responders With Pegylated Interferon Alpha Plus Ribavirin Plus Pioglitazone

First Posted Date
2007-02-09
Last Posted Date
2015-05-28
Lead Sponsor
University Hospital, Geneva
Target Recruit Count
5
Registration Number
NCT00433069
Locations
🇨🇭

Service de Gastroentérologie et d'Hépatologie, University Hospital, Geneva, GE, Switzerland

Study of Nitazoxanide, Peginterferon, and Ribavirin Combination Therapies in the Treatment of Chronic Hepatitis C

First Posted Date
2007-01-12
Last Posted Date
2008-09-25
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
121
Registration Number
NCT00421434
Locations
🇪🇬

Department of Tropical Medicine & Infectious Diseases, Alexandria University, Alexandria, Egypt

🇪🇬

Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine, Tanta, Egypt

A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

First Posted Date
2007-01-11
Last Posted Date
2014-08-05
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
465
Registration Number
NCT00420784
Locations
🇺🇸

North Shore University Hospital, Manhasset, New York, United States

🇳🇱

Academic Medical Center, Amsterdam, Netherlands

🇺🇸

University of Florida, Gainesville, Florida, United States

and more 31 locations

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

First Posted Date
2006-12-14
Last Posted Date
2013-08-08
Lead Sponsor
Human Genome Sciences Inc.
Target Recruit Count
933
Registration Number
NCT00411385
Locations
🇺🇸

Atlanta Gastroenterology Associates, Atlanta, Georgia, United States

🇺🇸

Temple University Hospital, Philadelphia, Pennsylvania, United States

🇺🇸

Baylor University Medical Center, Dallas, Texas, United States

and more 156 locations
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