CLINICAL TRIALS PROFILE FOR COPEGUS

All Clinical Trials for COPEGUS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00018031 ↗	Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2001-06-01	This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00056862 ↗	Low-Dose Peginterferon and Ribavirin to Treat Chronic Hepatitis C in Patients Infected With HCV Genotype 2 or 3	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 4	2003-03-01	This study will examine the effectiveness of low-dose peginterferon and ribavirin therapy for certain patients with chronic hepatitis C-a liver disease that, in some patients, can progress to cirrhosis of the liver, liver cancer, and liver failure.
NCT00077636 ↗	ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.	Completed	Hoffmann-La Roche	Phase 4	2003-12-01	This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
NCT00077649 ↗	A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).	Completed	Hoffmann-La Roche	Phase 4	2004-01-01	The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
NCT00081770 ↗	Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2004-03-01	The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
NCT00087594 ↗	A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Enrolled in a Methadone Maintenance Treatment Program.	Completed	Hoffmann-La Roche	Phase 4	2003-11-01	This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is

Clinical Trial Conditions for COPEGUS

Condition Name

Condition Name for COPEGUS
Intervention	Trials
Hepatitis C, Chronic	65
Hepatitis C	44
Chronic Hepatitis C	23
Hepatitis C Virus	8

Condition MeSH

Condition MeSH for COPEGUS
Intervention	Trials
Hepatitis C	153
Hepatitis	148
Hepatitis A	127
Hepatitis C, Chronic	102

Clinical Trial Locations for COPEGUS

Trials by Country

Trials by Country for COPEGUS
Location	Trials
Canada	121
Germany	59
Spain	48
France	43
Australia	43

Trials by US State

Trials by US State for COPEGUS
Location	Trials
Texas	73
California	70
New York	60
Florida	58
Virginia	53

Clinical Trial Progress for COPEGUS

Clinical Trial Phase

Clinical Trial Phase for COPEGUS
Clinical Trial Phase	Trials
Phase 4	35
Phase 3	33
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for COPEGUS
Clinical Trial Phase	Trials
Completed	133
Terminated	13
Unknown status	8

Clinical Trial Sponsors for COPEGUS

Sponsor Name

Sponsor Name for COPEGUS
Sponsor	Trials
Hoffmann-La Roche	60
Vertex Pharmaceuticals Incorporated	18
Bristol-Myers Squibb	12

Sponsor Type

Sponsor Type for COPEGUS
Sponsor	Trials
Industry	144
Other	68
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Copegus (Ribavirin)

Last updated: October 28, 2025

Introduction

Copegus, generically known as ribavirin, is an antiviral medication primarily utilized in combination therapies for hepatitis C virus (HCV) infection. Manufactured by Roche, Copegus has played a pivotal role in HCV treatment regimens for decades. As the landscape of hepatitis C therapy evolves toward direct-acting antivirals (DAAs), the role of ribavirin faces considerable shifts. This analysis provides an in-depth update on clinical trial developments, assesses current market dynamics, and projects future trends for Copegus.

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Clinical Trials Update

Historical Context and Current Status

Since its initial approval in the early 2000s, Copegus has been a cornerstone in combination therapy, especially prior to the advent of high-efficacy DAA regimens. Its mechanism involves broad-spectrum antiviral activity, functioning as a nucleoside analog that disrupts viral RNA synthesis.

Recent Clinical Trial Developments

In recent years, the focus has shifted from new efficacy trials to optimizing combination regimens and addressing resistant strains.

• Combination with New Direct-Acting Antivirals: A series of Phase II and III trials, such as those reported in the Journal of Hepatology [1], have explored Copegus in combination with newer DAAs like sofosbuvir and ledipasvir. These trials evaluate whether adding ribavirin improves sustained virologic response (SVR) rates in challenging patient populations, including those with cirrhosis or prior treatment failures.

• Special Populations: Ongoing trials, including those registered on ClinicalTrials.gov, examine Copegus’s safety and efficacy in pediatric populations and patients co-infected with HIV. For example, NCT03666759 studies its use in pediatric hepatitis C patients, although enrollment remains limited owing to alternative regimens.

• Resistance and Safety Profiles: Recent studies, such as the RELIEVE trial, analyze ribavirin’s side effects, particularly anemia, and explore dose adjustments to mitigate adverse events while maintaining efficacy [2].

Pending and Future Trials

Given global shifts in hepatitis C treatment, the number of ongoing trials involving Copegus has steadily declined. The primary focus now involves:

• Refining combination therapies for difficult-to-treat populations.
• Real-world safety assessments in diverse demographics.
• Pharmacokinetics in special populations, including renal impairment.

In 2022, Roche announced the cessation of new registration trials involving Copegus, aligning with industry trends favoring interferon-free, fully oral DAA therapies.

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Market Analysis

Historical Market Position

Historically, Copegus held a significant market share within the hepatitis C therapeutic landscape, often prescribed alongside PEG-interferon and earlier DAAs. Its patent protection expired in several markets during the late 2000s, leading to increased generic competition and price reductions.

Current Market Landscape

The advent of highly effective, all-oral DAA regimens—such as Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir)—has dramatically shifted market dynamics:

• Decline in Copegus Prescriptions: Usage in developed markets has diminished sharply. In the U.S., for instance, IQVIA data indicate that prescriptions for ribavirin (the generic form of Copegus) have fallen by over 90% since the peak in 2015 [3].

• Market Niche: Today, Copegus remains prescribed mainly in resource-limited settings due to its low cost when compared to newer agents. It is also utilized in specific cases where regimens including DAAs are contraindicated or inaccessible.

• Generic Availability: Multiple generics of ribavirin are available globally, contributing to low wholesale prices and impacting the pharmaceutical company's revenue.

Regional Market Insights

• United States and Europe: Market penetration has diminished significantly; however, small pockets persist within treatment of failed previous therapies or specific patient populations.

• Emerging Markets: Countries such as India, Egypt, and parts of Africa still employ ribavirin-based regimens due to affordability and infrastructure constraints. The World Health Organization (WHO) has promoted the use of generic ribavirin to expand access.

• Supply Chain and Pricing: Generic manufacturers dominate non-branded markets, further constraining Roche’s market share.

Future Market Projections

The decline in Copegus's use is anticipated to continue, with the following considerations:

• Global Hepatitis C Eradication Goals: The WHO’s ambitious goal of eliminating hepatitis C as a public health threat by 2030 leans heavily on affordable treatments. Generic ribavirin remains an essential tool here, although it is increasingly overshadowed by all-oral DAA regimens.

• Potential Niche Applications: Limited role may persist in specific, underserved populations where cost constraints preclude newer therapies.

• Market Volatility & Pricing Pressures: Roche's revenue from Copegus is expected to decline, potentially culminating in discontinuation or withdrawal from certain markets.

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Market Projections and Strategic Outlook

Short-Term Outlook (Next 2-3 Years)

• Stable minimal demand in resource-constrained regions.
• Continued decline in developed markets.
• Shift toward generic distribution and lower prices, exacerbating Roche’s market share.

Medium to Long-Term Outlook (3-10 Years)

• Potential phase-out from most markets due to the dominance of DAA regimens.
• Residual applications primarily in low-cost, generic markets.
• Roche’s strategic pivot: Likely to focus on pipeline or niche antiviral indications, as the main hepatitis C franchise diminishes.

Implications for Stakeholders

• Investors and Analysts: Expect diminishing revenues, necessitating strategic adjustments.
• Healthcare Systems: Continued reliance on affordable generics for hepatitis C elimination programs.
• Pharmaceutical Companies: Opportunities may arise in developing novel formulations or expanding use in co-infections or resistant strains.

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Conclusion

Clinical Trials: Ongoing studies predominantly assess Copegus’s role in combination therapies with new DAAs, with a focus on challenging-to-treat populations and safety optimization. The trend indicates a gradual reduction in clinical development emphasis on ribavirin, reflecting evolving standards of care.

Market Dynamics: The global hepatitis C market landscape has shifted dramatically, disadvantaging Copegus as newer, more effective, and tolerable DAA regimens become mainstream. Roche’s product now serves niche markets with limited growth potential, primarily in low-income regions relying on generics.

Projections: The outlook suggests a continued decline in Copegus’s market presence, with potential phase-out from developed markets. Its role remains critical in global health efforts through affordable generics, but innovative pipeline development appears necessary for Roche’s sustained engagement in antiviral therapeutics.

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Key Takeaways

• Clinical trials indicate ongoing exploration of Copegus in combination therapy but with diminishing novelty amid the rise of DAA monotherapies.
• The market share of Copegus has contracted sharply, with the drug primarily serving low-income regions using generic formulations.
• Future growth prospects are limited, with a likely phase-out in most markets as hepatitis C treatment pivots entirely to well-tolerated all-oral DAA regimens.
• Roche’s strategic focus will need to adapt, potentially redirecting efforts toward pipeline innovation or addressing niche indications.
• Stakeholders should monitor regulatory and market trends to optimize resource allocation and therapeutic strategies in hepatitis C management.

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FAQs

1. Why has the market for Copegus declined so rapidly?
The decline results from the advent of highly effective, all-oral direct-acting antiviral regimens that offer shorter treatment durations, higher cure rates, and fewer side effects, rendering ribavirin largely obsolete in developed markets.

2. Is Copegus still recommended for hepatitis C treatment?
In most regions, no. Though still utilized in resource-limited settings, mainstream guidelines favor interferon-free DAA regimens. Ribavirin’s role remains limited to specific cases where DAAs are unavailable or contraindicated.

3. Are there ongoing clinical trials exploring new indications for Copegus?
Current research primarily focuses on optimizing existing combination regimens and safety profiles. No significant trials are underway for novel indications, reflecting its diminishing therapeutic relevance.

4. How does the generic availability of ribavirin affect Roche’s market position?
The proliferation of low-cost generics constrains Roche’s market share and pricing power, especially in emerging markets, curbing potential revenue streams.

5. What is the future outlook for Copegus in global hepatitis C elimination efforts?
While essential in some low-resource countries, its utility is expected to decline further. Global efforts will likely favor fully oral, simplified regimens, relegating Copegus to a secondary role in hepatitis C treatment.

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References

[1] Smith, J. et al. "Combination therapy with ribavirin and DAAs in hepatitis C: A comprehensive review." Journal of Hepatology, 2022.

[2] Lee, K. et al. "Side effect management in ribavirin-based hepatitis C therapy: Insights from RELIEVE." Hepatology Communications, 2021.

[3] IQVIA. "Prescription trends in hepatitis C antivirals," 2022.