CLINICAL TRIALS PROFILE FOR RIBASPHERE

All Clinical Trials for Ribasphere

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.
NCT00446134 ↗	Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)	Completed	Bausch Health Americas, Inc.	Phase 2	2007-03-01	The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
NCT00446134 ↗	Taribavirin Phase 2 Dose Finding Study for the Treatment of Hepatitis C Virus (HCV)	Completed	Valeant Pharmaceuticals International, Inc.	Phase 2	2007-03-01	The objective of the study is to select an optimal dose of taribavirin by comparing the efficacy and safety of 3 taribavirin dose levels, 20, 25, and 30 mg/kg/day, versus ribavirin 800 to 1400 mg/day based on body weight, both administered in combination with peginterferon alfa-2b to therapy-naive patients with chronic Hepatitis C Virus (HCV) genotype 1 infection.
NCT00854802 ↗	A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients	Completed	Parexel	N/A	2009-01-01	The purpose of this study is to compare several Debio 025 (alisporivir)/peg-IFNα2a/ribavirin triple therapies with the current standard of care (SOC) in treatment naïve chronic hepatitis C genotype 1 patients.

Clinical Trial Conditions for Ribasphere

Condition Name

Condition Name for Ribasphere
Intervention	Trials
Hepatitis C	5
Hepatitis C Virus (HCV)	3
Chronic Hepatitis C	2
Hepatitis C, Chronic	2

Condition MeSH

Condition MeSH for Ribasphere
Intervention	Trials
Hepatitis	14
Hepatitis C	14
Hepatitis A	10
Hepatitis C, Chronic	5

Clinical Trial Locations for Ribasphere

Trials by Country

Trials by Country for Ribasphere
Location	Trials
United States	56
Japan	19
Australia	9
United Kingdom	7
Mexico	7

Trials by US State

Trials by US State for Ribasphere
Location	Trials
California	7
Texas	7
New York	5
Virginia	4
Maryland	3

Clinical Trial Progress for Ribasphere

Clinical Trial Phase

Clinical Trial Phase for Ribasphere
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	8

Clinical Trial Status

Clinical Trial Status for Ribasphere
Clinical Trial Phase	Trials
Completed	12
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for Ribasphere

Sponsor Name

Sponsor Name for Ribasphere
Sponsor	Trials
Bristol-Myers Squibb	5
National Institute of Allergy and Infectious Diseases (NIAID)	1
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for Ribasphere
Sponsor	Trials
Industry	15
Other	4
NIH	1

Clinical Trials, Market Analysis, and Projections for Ribavirin (Ribasphere)

Introduction to Ribavirin (Ribasphere)

Ribavirin, marketed under various names including Ribasphere, is a nucleoside analogue used primarily in the treatment of chronic hepatitis C (CHC) virus infection. It is often used in combination with interferon drugs such as peginterferon alfa-2a (Pegasys) or peginterferon alfa-2b (PEG-Intron)[4][5].

Clinical Trials and Efficacy

REALIZE Study

One of the pivotal clinical trials involving ribavirin is the REALIZE study, which evaluated the efficacy of telaprevir-based therapy in combination with pegylated-interferon and ribavirin for patients who had previously failed hepatitis C treatment. The study showed significant improvements in sustained virologic response (SVR) rates for patients treated with telaprevir-based therapy compared to those receiving pegylated-interferon and ribavirin alone. For example, prior relapsers achieved an SVR rate of 86% with telaprevir-based therapy versus 24% with the control arm. Similar improvements were seen in prior partial responders and null responders[1].

Safety and Tolerability

The REALIZE study also highlighted the safety and tolerability profile of ribavirin when used in combination with other antiviral drugs. The most common adverse events included rash and anemia, which were managed through dose adjustments and discontinuation strategies. The study demonstrated that delaying the start of telaprevir by four weeks (lead-in phase) did not provide additional clinical benefits[1].

Market Analysis

Global Market Growth

The global ribavirin market is projected to grow significantly over the forecast period of 2022-2029, driven by several key factors. The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 16.40% during this period[5].

Drivers of Growth

• Increasing Prevalence of Chronic Hepatitis C: The rise in global incidences of CHC is a major driver of the ribavirin market.
• Rising Healthcare Expenditure: Increased spending on healthcare infrastructure and research and development activities is fueling market growth.
• Government Initiatives and Awareness: Growing government initiatives and public awareness about hepatitis C treatment are also contributing to the market's expansion[5].

Regional Market Dynamics

• North America: This region dominates the ribavirin market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure.
• Asia-Pacific: This region is expected to grow rapidly due to increasing research and development activities and rising government support. The increasing prevalence of infectious and chronic diseases in this region is also driving demand for new treatments[5].

Market Projections

Revenue and Sales

The ribavirin market is expected to see substantial revenue growth. By 2029, the market is projected to expand significantly, driven by the increasing demand for effective treatments for hepatitis C and other conditions where ribavirin is used[5].

Competitive Landscape

The market is characterized by the presence of both global and local brands. The competition is influenced by factors such as the availability of generic versions, the emergence of new treatments, and the impact of biosimilars. For instance, the rise of direct-acting antivirals has changed the treatment landscape for hepatitis C, but ribavirin remains a crucial component in many treatment regimens[5].

Patient Epidemiology Analysis

Disease Epidemiology

The increasing prevalence of chronic hepatitis C globally is a key factor driving the demand for ribavirin. Additionally, the rise in other conditions such as thyroid cancer and hemorrhagic fever, for which ribavirin may be used, further contributes to the market's growth[5].

Demographic Factors

The market analysis also considers demographic factors such as age and geographic distribution. For example, the ribavirin market is segmented into adult and pediatric demographics, with varying dosage forms and treatment protocols[5].

Challenges and Opportunities

Regulatory Environment

Changes in regulations and healthcare policies can significantly impact the ribavirin market. For instance, contraindications and boxed warnings associated with ribavirin use, such as the risk of serious disorders and anemia, must be carefully managed[4].

Emerging Markets

The rise in research and development activities, particularly in regions like Asia-Pacific, presents opportunities for market growth. Emerging markets with growing government support and increasing healthcare expenditure are expected to drive the demand for ribavirin in the forecast period[5].

Key Takeaways

• Clinical Efficacy: Ribavirin, when used in combination with other antiviral drugs, has shown significant improvements in SVR rates for patients with chronic hepatitis C.
• Market Growth: The global ribavirin market is projected to grow at a CAGR of 16.40% from 2022 to 2029.
• Regional Dynamics: North America and Asia-Pacific are key regions driving the market growth due to their healthcare infrastructure and government support.
• Drivers of Growth: Increasing prevalence of CHC, rising healthcare expenditure, and government initiatives are major drivers of the market.
• Challenges and Opportunities: Regulatory changes, emerging markets, and the rise of new treatments present both challenges and opportunities for the ribavirin market.

FAQs

Q: What is the primary use of ribavirin in medical treatment? A: Ribavirin is primarily used in the treatment of chronic hepatitis C (CHC) virus infection, often in combination with interferon drugs.

Q: What were the key findings of the REALIZE study regarding ribavirin? A: The REALIZE study showed that telaprevir-based therapy, which includes ribavirin, significantly improved SVR rates for patients who had previously failed hepatitis C treatment.

Q: What is the projected growth rate of the global ribavirin market? A: The global ribavirin market is expected to grow at a CAGR of 16.40% from 2022 to 2029.

Q: Which regions are expected to drive the growth of the ribavirin market? A: North America and Asia-Pacific are expected to be the key regions driving the growth of the ribavirin market.

Q: What are the major drivers of the ribavirin market growth? A: The major drivers include the increasing prevalence of CHC, rising healthcare expenditure, and growing government initiatives and public awareness.

Sources

1. Results From Phase 3 REALIZE Study Showed Telaprevir-Based Therapy Significantly Improved SVR (Viral Cure) Rates in People Whose Prior Treatment For Hepatitis C Was Unsuccessful.
   • Investors.vrtx.com
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
   • Drug-dev.com
3. Clinical Trials Market Size, Share, Industry Trends, Growth, 2032.
   • Fortunebusinessinsights.com
4. Clinical Policy: Ribavirin (Copegus, Moderiba, Rebetol, Ribasphere).
   • Superiorhealthplan.com
5. Global Ribavirin Market - Industry Trends and Forecast to 2029.
   • Databridgemarketresearch.com

Last updated: 2025-01-07