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
-

Zidovudine Levels in HIV Infected Patients Being Treated for HCV

First Posted Date
2003-04-24
Last Posted Date
2009-08-07
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
16
Registration Number
NCT00059358
Locations
🇵🇷

UPR Adult ACTU, San Juan, Puerto Rico

Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3

Phase 4
Completed
Conditions
Interventions
First Posted Date
2003-03-25
Last Posted Date
2013-12-06
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
58
Registration Number
NCT00056862
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Treatment of Hepatitis C in Hemophilic Patients With HIV

Phase 2
Completed
Conditions
First Posted Date
2003-02-27
Last Posted Date
2008-07-30
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
22
Registration Number
NCT00055341
Locations
🇺🇸

University of Cincinnati, Cincinnati, Ohio, United States

Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation

Phase 3
Completed
Conditions
First Posted Date
2003-01-27
Last Posted Date
2010-03-30
Lead Sponsor
Fred Hutchinson Cancer Center
Registration Number
NCT00016081
Locations
🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇺🇸

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States

🇺🇸

University of Chicago Cancer Research Center, Chicago, Illinois, United States

and more 1 locations

Hepatitis C Antiviral Resistance in African-Americans

Phase 3
Completed
Conditions
Interventions
First Posted Date
2002-06-10
Last Posted Date
2017-08-03
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
401
Registration Number
NCT00038974
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

🇺🇸

University of Miami School of Medicine, Miami, Florida, United States

and more 5 locations

A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

Phase 1
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2021-10-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
15
Registration Number
NCT00000772
Locations
🇺🇸

Beth Israel Deaconess - East Campus A0102 CRS, Boston, Massachusetts, United States

🇺🇸

University of Minnesota, ACTU, Minneapolis, Minnesota, United States

A Study of Ribavirin in the Treatment of Patients With AIDS and AIDS-Related Problems

Phase 1
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
96
Registration Number
NCT00001015
Locations
🇺🇸

Bellevue Hosp / New York Univ Med Ctr, New York, New York, United States

🇺🇸

Harvard (Massachusetts Gen Hosp), Boston, Massachusetts, United States

🇺🇸

Univ of California / San Diego Treatment Ctr, San Diego, California, United States

and more 2 locations

The Safety and Effectiveness of Ribavirin in the Early Stages of HIV-Infection

Not Applicable
Terminated
Conditions
First Posted Date
2001-08-31
Last Posted Date
2005-06-24
Lead Sponsor
ICN Pharmaceuticals
Registration Number
NCT00002298

A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome

Not Applicable
Completed
Conditions
First Posted Date
2001-08-31
Last Posted Date
2010-08-27
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
130
Registration Number
NCT00001123
Locations
🇺🇸

NIAID/DMID/CASG Central Unit, Birmingham, Alabama, United States

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