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 Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

First Posted Date
2007-09-26
Last Posted Date
2014-08-05
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
117
Registration Number
NCT00535847
Locations
🇺🇸

Atlanta Gastroenterology Associates, Atlanta, Georgia, United States

🇺🇸

South Denver Gastroenterology, Englewood, Colorado, United States

🇺🇸

University of Florida, Gainesville, Florida, United States

and more 38 locations

Phase IV Study to Evaluate the Efficacy/Safety to Extend Treatment and High Dose of Ribavirin in co-Infected Patients

First Posted Date
2007-09-10
Last Posted Date
2009-01-29
Lead Sponsor
Hospital Carlos III, Madrid
Target Recruit Count
384
Registration Number
NCT00526448
Locations
🇪🇸

Hospital Parc Taulí, Sabadell, Barcelona, Spain

🇪🇸

Hospital do Meixoeiro, Vigo, Pontevedra, Spain

🇪🇸

Hospital Universitario de Canarias, La Laguna, Santa Cruz de Tenerife, Spain

and more 37 locations

Evaluating the Safety of Two Medications to Treat Hepatitis C in People With Thalassemia (The HepC Study)

Phase 2
Completed
Conditions
First Posted Date
2007-07-18
Last Posted Date
2014-03-04
Lead Sponsor
Carelon Research
Target Recruit Count
21
Registration Number
NCT00502788
Locations
🇺🇸

Weill Medical College of Cornell University, New York, New York, United States

🇺🇸

Children's Hospital and Research Center at Oakland, Oakland, California, United States

🇨🇦

Toronto General Hospital, Universty Health Network, Toronto, Ontario, Canada

and more 2 locations

Comparison of Pegasys Versus Peg-Intron for Treatment of Chronic Hepatitis C Genotype 4

First Posted Date
2007-07-17
Last Posted Date
2012-10-23
Lead Sponsor
Amr Hafez
Target Recruit Count
217
Registration Number
NCT00502099

Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-07-12
Last Posted Date
2012-08-01
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
51
Registration Number
NCT00500578
Locations
🇺🇸

U.T.M.D. Anderson Cancer Center, Houston, Texas, United States

Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

First Posted Date
2007-07-03
Last Posted Date
2014-05-08
Lead Sponsor
Romark Laboratories L.C.
Target Recruit Count
64
Registration Number
NCT00495391
Locations
🇺🇸

VA Palo Alto Healthcare System, Palo Alto, California, United States

🇺🇸

McGuire VA Medical Center, Richmond, Virginia, United States

🇺🇸

Nashville Medical Research Institute, Nashville, Tennessee, United States

and more 7 locations

An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals

Phase 1
Completed
Conditions
First Posted Date
2007-06-21
Last Posted Date
2017-07-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
41
Registration Number
NCT00489385
Locations
🇺🇸

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

Ribavirin, Its Dosing Regime

Phase 4
Completed
Conditions
Interventions
First Posted Date
2007-06-08
Last Posted Date
2018-01-09
Lead Sponsor
Maastricht University Medical Center
Target Recruit Count
15
Registration Number
NCT00484328
Locations
🇳🇱

University of Maastricht, Maastricht, Netherlands

S-Adenosyl Methionine (SAMe) to Treat Patients With Chronic Hepatitis C

First Posted Date
2007-05-21
Last Posted Date
2013-07-05
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
24
Registration Number
NCT00475176
Locations
🇺🇸

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

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