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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
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
-

Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection

Phase 1
Completed
Conditions
HIV-1 Infection
Hepatitis
Interventions
Drug: Ledipasvir/Sofosbuvir
Drug: Sofosbuvir
Drug: Ribavirin
First Posted Date
2014-05-01
Last Posted Date
2018-04-27
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
44
Registration Number
NCT02128217
Locations
🇺🇸

7804 Weill Cornell Chelsea CRS, New York, New York, United States

🇺🇸

2701 Northwestern University CRS, Chicago, Illinois, United States

🇺🇸

Rush Univ. Med. Ctr. ACTG CRS (2702), Chicago, Illinois, United States

and more 9 locations

Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis

Phase 4
Completed
Conditions
Hepatitis C Virus Infection
Interventions
First Posted Date
2014-05-01
Last Posted Date
2016-08-03
Lead Sponsor
Gilead Sciences
Target Recruit Count
66
Registration Number
NCT02128542

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

Phase 2
Completed
Conditions
Chronic HCV Infection
Interventions
Drug: SOF
Drug: LDV/SOF
Drug: RBV
First Posted Date
2014-04-22
Last Posted Date
2016-12-06
Lead Sponsor
Gilead Sciences
Target Recruit Count
122
Registration Number
NCT02120300

Evaluation of Safety, Tolerability, and Antiviral Activity of Chlorcyclizine HCl in Patients With Chronic Hepatitis C

Phase 1
Completed
Conditions
Chronic Hepatitis C
Interventions
First Posted Date
2014-04-21
Last Posted Date
2020-06-09
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
24
Registration Number
NCT02118012
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

Terminated
Conditions
Hepatitis C, Chronic
Interventions
Drug: Boceprevir
Drug: Simeprevir
Drug: Pegylated Interferon (Peginterferon) Alfa-2a
Drug: Ribavirin
First Posted Date
2014-04-21
Last Posted Date
2016-12-12
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
19
Registration Number
NCT02118597

Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir

Not Applicable
Completed
Conditions
Hepatitis C, Chronic
Cirrhosis
Interventions
First Posted Date
2014-04-14
Last Posted Date
2017-03-15
Lead Sponsor
Louis Stokes VA Medical Center
Target Recruit Count
50
Registration Number
NCT02113631
Locations
🇺🇸

Louis Stokes Cleveland VA medical center, Cleveland, Ohio, United States

Boceprevir in End Stage Renal Disease (ESRD)

Not Applicable
Withdrawn
Conditions
End Stage Renal Disease
Hepatitis C Infection
Interventions
Drug: P-IFN alfa 2a
Drug: P-IFN alfa 2b
Drug: Ribavirin
Drug: Boceprevir
First Posted Date
2014-04-14
Last Posted Date
2015-09-23
Lead Sponsor
Columbia University
Registration Number
NCT02112630

Therapy With Asunaprevir, Daclatasvir, Ribavirin and Pegylated Interferon Alpha-2a in HCV Genotype 4-infected Patients Who Have Failed to a Previous Therapy With Peg-Interferon/Ribavirin (ANRS HC32 QUATTRO)

Phase 2
Completed
Conditions
Hepatitis C Virus Genotype 4 Infection
Interventions
First Posted Date
2014-04-08
Last Posted Date
2017-01-24
Lead Sponsor
ANRS, Emerging Infectious Diseases
Target Recruit Count
60
Registration Number
NCT02107365
Locations
🇫🇷

Hôpital Jean Verdier, Bondy, France

🇫🇷

Hôpital de Haut Lévêque, Bordeaux Pessac, France

🇫🇷

Hôpital Beaujon, Clichy, France

and more 22 locations
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