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
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]
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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