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Ribavirin (Copegus®)
Ribavirin is a nucleoside analog that inhibits viral RNA synthesis by interfering with guanosine triphosphate pools and viral polymerase activity.
Ribavirin is a nucleoside analog that inhibits viral RNA synthesis by interfering with guanosine triphosphate pools and viral polymerase activity. Used for Chronic hepatitis C virus (HCV) infection in combination with peginterferon alfa or direct-acting antivirals, Severe respiratory syncytial virus (RSV) infection in immunocompromised patients.
At a glance
| Generic name | Ribavirin (Copegus®) |
|---|---|
| Also known as | COPEGUS (RIBAVIRIN) |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Drug class | Nucleoside analog antiviral |
| Target | Viral RNA-dependent RNA polymerase; inosine monophosphate dehydrogenase (IMPDH) |
| Modality | Small molecule |
| Therapeutic area | Virology/Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Ribavirin is converted intracellularly to its active triphosphate form, which depletes cellular GTP pools and directly inhibits viral RNA-dependent RNA polymerase. This dual mechanism reduces viral replication across multiple RNA viruses. It has been used primarily in combination with interferon for hepatitis C virus (HCV) treatment, though its exact mechanism in HCV remains incompletely understood.
Approved indications
- Chronic hepatitis C virus (HCV) infection in combination with peginterferon alfa or direct-acting antivirals
- Severe respiratory syncytial virus (RSV) infection in immunocompromised patients
Common side effects
- Hemolytic anemia
- Fatigue
- Headache
- Nausea
- Dyspnea
- Teratogenicity/reproductive toxicity
- Hyperuricemia
Key clinical trials
- Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19_#2 (PHASE1)
- A Phase 1b/2a Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C (PHASE1, PHASE2)
- Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (PHASE2)
- Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012) (PHASE2)
- A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
- Evaluate the Efficacy and Safety of TG-2349 in Subjects With Hepatitis C Infection (PHASE2)
- A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection (PHASE2, PHASE3)
- Bioequivalence Study of Ribavirin in Healthy Adult Subjects Under Fed Condition (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ribavirin (Copegus®) CI brief — competitive landscape report
- Ribavirin (Copegus®) updates RSS · CI watch RSS
- Vertex Pharmaceuticals Incorporated portfolio CI