CLINICAL TRIALS PROFILE FOR REBETOL

All Clinical Trials for Rebetol

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.
NCT00039871 ↗	PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-05-01	The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).
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.
NCT00087607 ↗	Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).	Completed	Hoffmann-La Roche	Phase 4	2004-01-01	This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
NCT00104052 ↗	Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2005-02-01	The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in pediatric subjects with chronic hepatitis C.
NCT00146016 ↗	Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients	Completed	UMC Utrecht	Phase 3	2000-02-01	* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

Clinical Trial Conditions for Rebetol

Condition Name

Condition Name for Rebetol
Intervention	Trials
Hepatitis C, Chronic	47
Hepatitis C	29
Chronic Hepatitis C	19
Hepacivirus	6

Condition MeSH

Condition MeSH for Rebetol
Intervention	Trials
Hepatitis C	89
Hepatitis	84
Hepatitis C, Chronic	74
Hepatitis A	74

Clinical Trial Locations for Rebetol

Trials by Country

Trials by Country for Rebetol
Location	Trials
United States	59
Japan	8
Canada	4
Spain	4
Italy	4

Trials by US State

Trials by US State for Rebetol
Location	Trials
California	6
Texas	6
Virginia	5
New York	4
Florida	3

Clinical Trial Progress for Rebetol

Clinical Trial Phase

Clinical Trial Phase for Rebetol
Clinical Trial Phase	Trials
Phase 4	18
Phase 3	19
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Rebetol
Clinical Trial Phase	Trials
Completed	69
Terminated	15
Withdrawn	6

Clinical Trial Sponsors for Rebetol

Sponsor Name

Sponsor Name for Rebetol
Sponsor	Trials
Merck Sharp & Dohme Corp.	55
Schering-Plough	6
TCM Biotech International Corp.	2

Sponsor Type

Sponsor Type for Rebetol
Sponsor	Trials
Industry	84
Other	54
NIH	2

REBETOL: Clinical Trials, Market Analysis, and Projections

Introduction

REBETOL, also known as ribavirin, has been a cornerstone in the treatment of chronic hepatitis C virus (HCV) infection for several decades. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Early Clinical Trials

REBETOL was initially approved in combination with naked Interferon alpha, marking the beginning of oral treatments for HCV. The combination of REBETOL with PEGylated Interferon alpha (PEG-IFN) significantly improved treatment efficacy. For Genotype-1 patients, this combination achieved response rates of 40%-50% over a 48-week treatment period. For Genotype 2 and 3 patients, the efficacy increased to 70%-80% with a shorter 24-week treatment program[2].

Combination Therapies

Clinical trials have consistently shown that REBETOL is most effective when used in combination with other antiviral agents. For example, the combination of REBETOL with PEG-IFN and other protease inhibitors like telaprevir (Incivek) or boceprevir (Victrelis) further enhanced treatment outcomes. These combinations were particularly beneficial for patients who had failed previous treatments or had advanced liver disease[2][4].

Sustained Virological Response (SVR)

The primary measure of success in HCV treatment is the Sustained Virological Response (SVR), which indicates that the virus is undetectable 24 weeks after the completion of treatment. Studies have shown that REBETOL in combination with PEG-IFN and other agents can achieve high SVR rates. For instance, the combination of REBETOL with PEG-IFN and telaprevir achieved SVR rates of up to 65% for Type 1 patients[2].

Market Analysis

Historical Market Performance

REBETOL was a key player in the HCV treatment market, especially during the early 2000s. The market for HCV treatments was once valued at around $20 billion annually in the US but has significantly declined due to the introduction of more effective and convenient treatments. By 2020, the market had reduced to about $5 billion, largely due to the reduction in the patient pool as more patients achieved a cure with newer therapies[2].

Current Market Scenario

The viral hepatitis market, which includes HCV treatments, is expected to grow at a CAGR of 2.69% from 2024 to 2034. However, REBETOL's market share has diminished with the advent of direct-acting antivirals (DAAs) that offer higher efficacy and better tolerability. Companies like Gilead Sciences have dominated the market with their innovative DAAs, further reducing the demand for older treatments like REBETOL[5].

Projections and Future Outlook

Declining Market Share

Given the significant advancements in HCV treatment, REBETOL's market share is expected to continue declining. The introduction of generic equivalents and the expiration of patents for newer drugs will likely further reduce the market for REBETOL and similar older treatments[2].

Pricing and Accessibility

Future price reductions for REBETOL and other older HCV treatments are anticipated, primarily driven by the introduction of generic versions and aggressive contract pricing. This could make REBETOL more accessible in developing markets where newer treatments may be unaffordable[2].

Competitive Landscape

The competitive landscape in the HCV treatment market is dominated by newer DAAs, which offer once-daily oral dosing for as little as 8 weeks with near 100% efficacy and improved safety profiles. Companies like Gilead Sciences continue to lead the market with their innovative treatments, making it challenging for older drugs like REBETOL to maintain significant market presence[2][5].

Key Takeaways

• Clinical Efficacy: REBETOL is most effective when used in combination with other antiviral agents, achieving high SVR rates.
• Market Decline: The market for REBETOL has significantly declined due to the introduction of more effective and convenient treatments.
• Future Outlook: REBETOL's market share is expected to continue declining with the introduction of generic equivalents and the dominance of newer DAAs.
• Pricing: Future price reductions are anticipated, making REBETOL more accessible in developing markets.

FAQs

What is REBETOL used for?

REBETOL, or ribavirin, is used in the treatment of chronic hepatitis C virus (HCV) infection, typically in combination with other antiviral agents.

How effective is REBETOL in treating HCV?

REBETOL is most effective when used in combination with PEG-IFN and other protease inhibitors, achieving high Sustained Virological Response (SVR) rates.

Why has the market for REBETOL declined?

The market for REBETOL has declined significantly due to the introduction of more effective and convenient direct-acting antivirals (DAAs) that offer higher efficacy and better tolerability.

What is the future outlook for REBETOL?

The market share for REBETOL is expected to continue declining as newer treatments dominate the market. However, it may remain accessible in developing markets due to potential price reductions.

Are there any ongoing clinical trials for REBETOL?

There are no significant ongoing clinical trials for REBETOL as a standalone treatment, as the focus has shifted to newer and more effective treatments.

How does REBETOL compare to newer HCV treatments?

REBETOL is less effective and less convenient compared to newer DAAs, which offer once-daily oral dosing for as little as 8 weeks with near 100% efficacy and improved safety profiles.