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
-

Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

First Posted Date
2006-05-10
Last Posted Date
2014-09-04
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
372
Registration Number
NCT00323804
Locations
🇫🇷

Service d'Hépatogastroentérologie - CH La Roche sur Yon, La Roche sur Yon, France

🇫🇷

Service d'Hépatogastroentérologie - CH Montélimar, Montelimar, France

🇫🇷

Centre Hospitalier, Saint Quentin, France

and more 40 locations

Chronic Hepatitis C Non-Responder Study With AdoMet and Betaine

Phase 2
Completed
Conditions
First Posted Date
2006-04-03
Last Posted Date
2010-10-28
Lead Sponsor
University Hospital, Basel, Switzerland
Target Recruit Count
30
Registration Number
NCT00310336
Locations
🇨🇭

University Hospital Basel, Basel, BS, Switzerland

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

First Posted Date
2006-03-20
Last Posted Date
2010-06-03
Lead Sponsor
Chugai Pharmaceutical
Target Recruit Count
180
Registration Number
NCT00304551
Locations
🇯🇵

Tohoku Region, Tohoku, Japan

🇯🇵

Hokkaido Region, Hokkaido, Japan

🇯🇵

Kyusyu Region, Kyusyu, Japan

and more 5 locations

Pegylated Interferon and Ribavirin Therapy in Chronic Hepatitis Genotype 4

Phase 4
Completed
Conditions
Interventions
First Posted Date
2006-01-18
Last Posted Date
2008-02-26
Lead Sponsor
Ain Shams University
Target Recruit Count
280
Registration Number
NCT00277862
Locations
🇪🇬

MISR Welding, Cairo, Egypt

🇪🇬

ELectricity Auth, Mynia and Cairo, Egypt

🇪🇬

AUS Specialized Hospital,, Cairo;, Cairo,, Egypt

and more 1 locations

Safety Study of Low Dose Interleukin 2 (IL-2) Plus PEG-IFN/RBV In Chronic Hepatitis C Virus Genotype I

First Posted Date
2006-01-16
Last Posted Date
2008-03-07
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
18
Registration Number
NCT00277758
Locations
🇺🇸

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

Phase 2 Study of VX-950, Pegasys and Copegus in Hepatitis C

Phase 2
Completed
Conditions
First Posted Date
2005-12-06
Last Posted Date
2007-12-21
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
12
Registration Number
NCT00262483
Locations
🇵🇷

Call for information, Santurce, Puerto Rico

Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

First Posted Date
2005-11-17
Last Posted Date
2017-04-06
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
121
Registration Number
NCT00255008

Trial of Peg-interferon Plus Epoetin-alfa for Treatment of Chronic Hepatitis C Virus Infection

First Posted Date
2005-11-03
Last Posted Date
2017-03-20
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
150
Registration Number
NCT00248339
Locations
🇺🇸

Virginia Commonwealth University, Richmond, Virginia, United States

Timing and Duration of Acute Hepatitis C Treatment

Phase 4
Completed
Conditions
First Posted Date
2005-10-19
Last Posted Date
2006-09-11
Lead Sponsor
Ain Shams University
Target Recruit Count
180
Registration Number
NCT00241618
Locations
🇪🇬

Shebin Liver Center, Cairo, Egypt

🇪🇬

ASU Specialized Hospital, Cairo, Egypt

🇪🇬

ASU, Cairo, Egypt

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