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 to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects

First Posted Date
2015-07-01
Last Posted Date
2021-10-05
Lead Sponsor
AbbVie
Target Recruit Count
64
Registration Number
NCT02486406
Locations
🇵🇷

San Jorge Children Hospital /ID# 136832, San Juan, Puerto Rico

🇺🇸

Seattle Children's Hospital /ID# 137019, Seattle, Washington, United States

🇩🇪

Helios Klinikum Wuppertal /ID# 142883, Wuppertal, Germany

and more 18 locations

Intravenous Ribavirin Protocol to Treat Individuals With Viral Hemorrhagic Fever

Not Applicable
Conditions
Interventions
First Posted Date
2015-06-26
Last Posted Date
2022-04-05
Lead Sponsor
U.S. Army Medical Research and Development Command
Target Recruit Count
30
Registration Number
NCT02483260
Locations
🇩🇪

Landstuhl Regional Medical Center, Landstuhl, APO Ae, Germany

Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-06-16
Last Posted Date
2018-11-16
Lead Sponsor
Gilead Sciences
Target Recruit Count
153
Registration Number
NCT02472886

Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment

First Posted Date
2015-06-02
Last Posted Date
2024-08-23
Lead Sponsor
Nova Scotia Health Authority
Target Recruit Count
44
Registration Number
NCT02460133

Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa

First Posted Date
2015-04-01
Last Posted Date
2017-12-13
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
120
Registration Number
NCT02405013
Locations
🇨🇮

CHU de Youpougon - Service de Gastro-entéro-hépatologie, Abidjan, Côte D'Ivoire

🇨🇲

Clinique de la Cathédrale, Yaoundé, Cameroon

🇸🇳

CHU Fann, Service des Maladies Infectieuses, Dakar, Senegal

and more 1 locations

Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-03-04
Last Posted Date
2020-03-06
Lead Sponsor
Gilead Sciences
Target Recruit Count
205
Registration Number
NCT02378935
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Indiana University, Indianapolis, Indiana, United States

🇺🇸

Southwest Care Center, Santa Fe, New Mexico, United States

and more 31 locations
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