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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

Overview

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

Research Report

Published: Jul 16, 2025

Ribavirin (DB00811): A Comprehensive Monograph on its Pharmacology, Clinical Utility, and Evolving Therapeutic Role

Executive Summary

Ribavirin is a synthetic guanosine analog prodrug that exhibits broad-spectrum antiviral activity against a diverse range of RNA and DNA viruses.[1] First synthesized in 1970, its clinical utility has been defined by a complex and evolving understanding of its pharmacology and therapeutic application. The drug's mechanism of action is notably multifaceted and remains a subject of extensive research. It is not mediated by a single pathway but rather a concert of concentration-dependent effects, including the inhibition of host inosine monophosphate dehydrogenase (IMPDH) leading to GTP depletion, the induction of lethal mutagenesis or "error catastrophe" in viral genomes, direct inhibition of viral polymerases, and significant immunomodulatory actions that enhance the host's antiviral response.[2]

Historically, Ribavirin became a cornerstone of antiviral therapy as a critical component of combination treatment for chronic hepatitis C virus (HCV) infection. While ineffective as a monotherapy for HCV, its addition to interferon-alfa, and later pegylated interferon, dramatically improved sustained virologic response (SVR) rates and, most importantly, prevented post-treatment relapse.[3] With the advent of highly effective direct-acting antiviral (DAA) agents, Ribavirin's role has transitioned from a primary therapy to a specialized adjuvant. It is now reserved for specific, difficult-to-treat patient populations—such as those with cirrhosis or certain HCV genotypes—to shorten treatment duration or bolster SVR rates in interferon-free regimens.[5]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/04/10
Phase 4
Completed
2024/12/20
Phase 3
Completed
Khyber Medical University Peshawar
2024/07/05
Phase 2
Recruiting
2024/01/25
Phase 2
Recruiting
Bernhard Nocht Institute for Tropical Medicine
2024/01/18
Phase 2
Not yet recruiting
Irrua Specialist Teaching Hospital
2023/07/11
Phase 1
Recruiting
2023/02/08
Phase 4
Terminated
2022/09/08
Phase 1
Completed
2022/07/21
Phase 4
UNKNOWN
2021/06/01
Phase 2
Completed
Bernhard Nocht Institute for Tropical Medicine

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Zydus Pharmaceuticals USA Inc.
68382-127
ORAL
400 mg in 1 1
11/10/2022
Navinta LLC
68475-003
RESPIRATORY (INHALATION)
6 g in 1 1
12/2/2022
Zydus Lifesciences Limited
65841-046
ORAL
200 mg in 1 1
9/27/2023
Zydus Pharmaceuticals USA Inc.
68382-395
RESPIRATORY (INHALATION)
6 g in 1 1
12/2/2022
Zydus Pharmaceuticals USA Inc.
68382-046
ORAL
200 mg in 1 1
11/10/2022
Aurobindo Pharma Limited
65862-207
ORAL
200 mg in 1 1
2/6/2024
Aurobindo Pharma Limited
65862-290
ORAL
200 mg in 1 1
2/6/2024
Zydus Lifesciences Limited
65841-603
ORAL
400 mg in 1 1
9/27/2023
Zydus Lifesciences Limited
65841-260
ORAL
200 mg in 1 1
9/27/2023
Zydus Pharmaceuticals USA Inc.
68382-129
ORAL
600 mg in 1 1
11/10/2022

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
IBAVYR ribavirin 200 mg film coated tablets bottle
243632
Medicine
A
3/15/2016

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PEGETRON
Merck Canada Inc
02246026
Capsule ,  Powder For Solution - Subcutaneous ,  Oral
200 MG / CAP
8/13/2002
PEGETRON
Merck Canada Inc
02246027
Powder For Solution ,  Capsule - Subcutaneous ,  Oral
200 MG / CAP
8/13/2002
REBETRON SOLUTION (ALBUMIN (HUMAN) FREE) (18 MIU MULTI-DOSE PEN / 200MG CAPSULES)
schering-plough canada inc
02241159
Liquid ,  Capsule ,  Kit - Oral ,  Subcutaneous
200 MG / CAP
12/23/1999
IBAVYR
pendopharm division of pharmascience inc
02425890
Tablet - Oral
400 MG
7/14/2014
VICTRELIS TRIPLE
Merck Canada Inc
02371472
Capsule ,  Powder For Solution - Oral ,  Subcutaneous
200 MG / CAP
8/16/2011
REBETRON READY TO USE SOLUTION (ALBUMIN(HUMAN)FREE) (6000000 IU/ML AND 200MG CAPSULES)
schering-plough canada inc
02239730
Capsule ,  Kit ,  Liquid - Oral ,  Subcutaneous
200 MG / CAP
3/31/1999
VICTRELIS TRIPLE
Merck Canada Inc
02371448
Capsule ,  Powder For Solution - Subcutaneous ,  Oral
200 MG / CAP
8/16/2011
PEGASYS RBV
Hoffmann-La Roche Limited
02253410
Solution ,  Tablet - Subcutaneous ,  Oral
200 MG / TAB
5/26/2004
PEGASYS RBV
Hoffmann-La Roche Limited
02253429
Tablet ,  Solution - Oral ,  Subcutaneous
200 MG / TAB
5/26/2004
MODERIBA
02436396
Tablet - Oral
200 MG
2/17/2015

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
REBETOL 200 MG CAPSULAS DURAS
99107003
CÁPSULA DURA
Diagnóstico Hospitalario
Not Commercialized
RIBAVIRINA AUROVITAS 200 MG CÁPSULAS DURAS EFG
Aurovitas Spain, S.A.U.
77096
CÁPSULA DURA
Diagnóstico Hospitalario
Not Commercialized
REBETOL 200 MG CAPSULAS DURAS
99107001
CÁPSULA DURA
Diagnóstico Hospitalario
Not Commercialized
RIBAVIRINA NORMON 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Laboratorios Normon S.A.
73658
COMPRIMIDO RECUBIERTO CON PELÍCULA
Diagnóstico Hospitalario
Commercialized
REBETOL 40 MG/ML SOLUCION ORAL
99107004
SOLUCIÓN ORAL
Diagnóstico Hospitalario
Not Commercialized
RIBAVIRINA TEVA 200 MG CAPSULAS DURAS EFG
09509004
CÁPSULA DURA
Diagnóstico Hospitalario
Not Commercialized
RIBAVIRINA TEVA 200 MG CAPSULAS DURAS EFG
09509003
CÁPSULA DURA
Diagnóstico Hospitalario
Not Commercialized
RIBAVIRINA TEVA PHARMA BV 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
09527003
COMPRIMIDO RECUBIERTO CON PELÍCULA
Diagnóstico Hospitalario
Not Commercialized
RIBAVIRINA TEVA PHARMA BV 200 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
09527008
COMPRIMIDO RECUBIERTO CON PELÍCULA
Diagnóstico Hospitalario
Not Commercialized
REBETOL 200 MG CAPSULAS DURAS
99107002
CÁPSULA DURA
Diagnóstico Hospitalario
Not Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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