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
-

12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF

First Posted Date
2015-11-16
Last Posted Date
2018-05-02
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Target Recruit Count
7
Registration Number
NCT02605304
Locations
🇺🇸

Ucsf Aids Crs (801), San Francisco, California, United States

🇺🇸

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

Evaluation of Unipeg® for Response and Ongoing Safety in Pakistani Population

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-11-11
Last Posted Date
2018-09-27
Lead Sponsor
Getz Pharma
Target Recruit Count
64
Registration Number
NCT02601976

Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2015-11-09
Last Posted Date
2018-11-16
Lead Sponsor
Gilead Sciences
Target Recruit Count
87
Registration Number
NCT02600351

Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

First Posted Date
2015-11-04
Last Posted Date
2023-04-20
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
100
Registration Number
NCT02596880
Locations
🇮🇷

Shariati Hospital, Tehran, Iran, Islamic Republic of

A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection

First Posted Date
2015-10-30
Last Posted Date
2017-01-30
Lead Sponsor
Trek Therapeutics, PBC
Target Recruit Count
16
Registration Number
NCT02593162
Locations
🇺🇸

Southern California Research Center, Coronado, California, United States

Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Canada

First Posted Date
2015-10-20
Last Posted Date
2019-03-27
Lead Sponsor
AbbVie
Target Recruit Count
565
Registration Number
NCT02581189
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