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 Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

First Posted Date
2014-11-17
Last Posted Date
2023-10-04
Lead Sponsor
Gilead Sciences
Target Recruit Count
1609
Registration Number
NCT02292706
Locations
🇺🇸

Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia, United States

🇺🇸

North Shore Health Inc., Manhasset, New York, United States

🇺🇸

Asheville Gastroenterology Associates, PA, Asheville, North Carolina, United States

and more 134 locations

Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

First Posted Date
2014-10-10
Last Posted Date
2014-10-10
Lead Sponsor
Tanta University
Target Recruit Count
30
Registration Number
NCT02261662
Locations
🇪🇬

Tanta University Hospital, Tanta, Gharbia, Egypt

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-09-25
Last Posted Date
2020-03-02
Lead Sponsor
Gilead Sciences
Target Recruit Count
226
Registration Number
NCT02249182

Coadministration of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) With Ribavirin (RBV) in Adults With Genotype 4 (GT4) Hepatitis C Virus (HCV) in Egypt

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-09-25
Last Posted Date
2021-07-30
Lead Sponsor
AbbVie
Target Recruit Count
160
Registration Number
NCT02247401

Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-08-20
Last Posted Date
2018-11-15
Lead Sponsor
Gilead Sciences
Target Recruit Count
269
Registration Number
NCT02220998
Locations
🇺🇸

Emory university, Atlanta, Georgia, United States

SMV + SOF With/Without RBV for IFN-II Patients With CHC

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-08-12
Last Posted Date
2018-06-19
Lead Sponsor
SC Liver Research Consortium, LLC
Target Recruit Count
24
Registration Number
NCT02214420
Locations
🇺🇸

Scripps Clinic, La Jolla, California, United States

🇺🇸

Clinical Research Centers of America, LLC, Murray, Utah, United States

🇺🇸

Icahn School of Medicine at Mt. Sinai, New York, New York, United States

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