CLINICAL TRIALS PROFILE FOR PEGINTRON

All Clinical Trials for PEGINTRON

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.
NCT00027742 ↗	Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	Completed	National Cancer Institute (NCI)	Phase 2	2001-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.
NCT00027742 ↗	Temozolomide and Interferon Alfa in Treating Patients With Stage III or Stage IV Melanoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2001-05-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.
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.
NCT00087568 ↗	A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin	Completed	Hoffmann-La Roche	Phase 4	2003-01-01	This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.
NCT00087646 ↗	REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Therapy in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Who Did Not Respond to Previous PegIntron (Peginterferon Alfa-2b (12KD))/Ribavirin Combinatio	Completed	Hoffmann-La Roche	Phase 4	2003-09-01	This 4 arm study is designed for patients with CHC who have not responded to peginterferon alfa-2b (12KD)/ribavirin combination therapy. In these patients, the effects of lengthening the duration of treatment, as well as including an initial 12-week period of high-dose PEGASYS (360 micrograms sc), are compared with the standard combination therapy of PEGASYS (180 micrograms sc) and ribavirin (1000-1200mg po). The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Clinical Trial Conditions for PEGINTRON

Condition Name

Condition Name for PEGINTRON
Intervention	Trials
Hepatitis C, Chronic	49
Hepatitis C	28
Chronic Hepatitis C	8
Hepacivirus	6

Condition MeSH

Condition MeSH for PEGINTRON
Intervention	Trials
Hepatitis	82
Hepatitis C	81
Hepatitis A	76
Hepatitis C, Chronic	67

Clinical Trial Locations for PEGINTRON

Trials by Country

Trials by Country for PEGINTRON
Location	Trials
United States	89
Japan	7
Netherlands	6
France	5
Germany	5

Trials by US State

Trials by US State for PEGINTRON
Location	Trials
Maryland	8
Pennsylvania	7
New York	6
Texas	5
Georgia	5

Clinical Trial Progress for PEGINTRON

Clinical Trial Phase

Clinical Trial Phase for PEGINTRON
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	29
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for PEGINTRON
Clinical Trial Phase	Trials
Completed	79
Terminated	10
Unknown status	8

Clinical Trial Sponsors for PEGINTRON

Sponsor Name

Sponsor Name for PEGINTRON
Sponsor	Trials
Merck Sharp & Dohme Corp.	64
Schering-Plough	6
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for PEGINTRON
Sponsor	Trials
Industry	89
Other	60
NIH	8

PEGINTRON: Clinical Trial Update, Market Analysis, and Projection

Last updated: February 19, 2026

Pegintron (peginterferon alfa-2b) has undergone significant clinical development, primarily for the treatment of hepatitis C virus (HCV) infection and, to a lesser extent, melanoma. Its market trajectory is now largely influenced by the advent of direct-acting antivirals (DAAs) for HCV and the evolving treatment landscape for melanoma.

What are the latest clinical trial updates for PEGINTRON?

Pegintron's primary indication, chronic hepatitis C, has seen its treatment paradigm shift dramatically with the introduction of DAAs. These newer therapies offer higher cure rates, shorter treatment durations, and improved safety profiles compared to interferon-based regimens, including Pegintron. Consequently, the number of new clinical trials investigating Pegintron for HCV has significantly declined.

Hepatitis C Virus (HCV) Trials

Pegintron was a cornerstone of combination therapy for HCV, typically used with ribavirin. Major clinical trials such as the IDEAL study (International Degenovo Interferon alfa-2a vs. Peginterferon alfa-2b Trial) and the ADVANCE study demonstrated its efficacy [1]. However, these trials are historical, reflecting the standard of care prior to DAAs.

Recent activity for Pegintron in HCV is limited to observational studies or post-marketing surveillance, often comparing outcomes with historical DAA data or assessing long-term safety in patient populations treated with Pegintron in the pre-DAA era. No significant prospective trials are ongoing or recently completed for novel indications of Pegintron in HCV. The focus has entirely shifted to DAA combinations.

Melanoma Trials

Pegintron, in combination with peginterferon alfa-2a, was investigated as adjuvant therapy for resected stage III malignant melanoma. The E1694 trial, conducted by the Eastern Cooperative Oncology Group (ECOG), was a pivotal study in this area. This trial, which enrolled patients with high-risk melanoma following surgical resection, aimed to determine if adjuvant interferon therapy could reduce the risk of recurrence or death [2].

While Pegintron (peginterferon alfa-2b) was studied, its use in this context has largely been superseded by newer immunotherapies and targeted therapies that have shown more robust efficacy and better tolerability profiles. Current melanoma treatment guidelines no longer prominently feature pegylated interferons as standard adjuvant therapy for stage III disease.

Other Investigational Areas

Historical research explored Pegintron for other viral infections and certain cancers, but these investigations did not lead to significant approved indications and have not been the focus of recent clinical development.

What is the current market status and key competitive landscape for PEGINTRON?

The market for Pegintron has been significantly impacted by the evolution of treatment standards. Its once-dominant position in hepatitis C treatment has been eroded by the advent of direct-acting antivirals (DAAs).

Hepatitis C Market Dynamics

The global market for hepatitis C therapeutics was once a multi-billion dollar industry driven by the need for effective treatments for millions of infected individuals. Pegintron, combined with ribavirin, was a standard of care for many years, offering a SVR (sustained virologic response) rate that was considered a cure.

However, the introduction of DAAs, such as sofosbuvir, ledipasvir, and glecaprevir/pibrentasvir, revolutionized HCV treatment. These therapies offer SVR rates exceeding 95% with treatment durations of 8 to 12 weeks, and significantly fewer side effects compared to interferon-based regimens [3].

As a result, Pegintron has been largely withdrawn or relegated to niche applications, particularly in regions with limited access to DAAs or for specific patient profiles where DAAs are contraindicated or less effective. Major pharmaceutical companies have phased out Pegintron from their HCV portfolios in developed markets.

Key Market Shifts in HCV Treatment:

• Pre-DAA Era: Pegintron + Ribavirin was a primary treatment option.
• Early DAA Era: DAAs began replacing interferon-based therapies due to superior efficacy and safety.
• Current Era: DAAs are the standard of care globally, with interferon-based treatments being largely obsolete in most developed countries.

Melanoma Market Dynamics

In the adjuvant melanoma setting, Pegintron faced competition from high-dose interferon alfa-2b. However, even in this indication, the landscape has changed considerably. Newer therapies, including immune checkpoint inhibitors like pembrolizumab and nivolumab, have demonstrated superior efficacy in reducing recurrence rates and improving overall survival for patients with resected stage III and IV melanoma [4].

Comparison of Adjuvant Melanoma Treatments:

Treatment Class	Efficacy (Recurrence Reduction)	Tolerability	Current Guideline Status
High-Dose Interferon Alfa-2b	Moderate	Poor	Largely superseded
Pegylated Interferon Alfa-2b	Similar to high-dose IFN	Poor	Largely superseded
Immune Checkpoint Inhibitors	High	Moderate	Standard of care
Targeted Therapies (BRAF+)	High (for BRAF mutations)	Moderate	Standard of care

The market has shifted decisively towards immunotherapies and targeted agents for adjuvant melanoma, diminishing the role of pegylated interferons.

Competitive Landscape

The direct competitors for Pegintron have evolved.

• HCV: The primary competitors are now the various DAA combinations from companies like Gilead Sciences (e.g., Harvoni, Epclusa), AbbVie (e.g., Mavyret), and Merck & Co. (e.g., Zepatier).
• Melanoma: Competitors include Bristol Myers Squibb (Opdivo, Yervoy), Merck & Co. (Keytruda), and numerous companies developing targeted therapies for specific mutations (e.g., vemurafenib, dabrafenib).

Pegintron's market share in its former primary indication (HCV) is now negligible in most key pharmaceutical markets. Its presence in melanoma adjuvant therapy is similarly minimal.

What are the future market projections for PEGINTRON?

The future market for Pegintron is projected to be extremely limited, primarily due to the therapeutic advancements that have rendered it obsolete in its former main indications.

Hepatitis C Projections

The global market for HCV treatment is expected to continue to decline in value as the pool of patients requiring treatment shrinks due to the high cure rates achieved with DAAs. Pegintron will likely see further market erosion, with its use confined to specific underserved markets or in rare cases where DAAs are not an option.

• Projected Market Share in HCV: < 0.1% in developed markets.
• Geographic Concentration: Potential residual use in regions with limited access to newer therapies.
• Therapeutic Relevance: Declining rapidly as DAA resistance is not a significant issue for current treatments.

Melanoma Projections

The adjuvant melanoma market is dominated by immunotherapies and targeted agents. Pegintron and similar interferon-based therapies are not expected to regain prominence.

• Projected Market Share in Melanoma: Negligible.
• R&D Focus: No significant investment in Pegintron for melanoma is anticipated.

Overall Market Trajectory

The overall market projection for Pegintron is one of continued decline and eventual obsolescence. Its manufacturing and distribution may cease in many regions as demand diminishes.

Factors influencing the limited future market:

• Superior Efficacy of DAAs in HCV: Higher cure rates, shorter treatment, fewer side effects.
• Advancements in Melanoma Treatment: Immunotherapies offer better outcomes and tolerability.
• Patent Expirations: While patents for Pegintron itself may have expired or be nearing expiration, the lack of ongoing development for new indications makes generic competition for a declining market less impactful.

Pegintron's legacy is as a critical step in the evolution of antiviral and cancer therapy, but its future as a commercially significant product is minimal.

Key Takeaways

• Pegintron's clinical development for hepatitis C is largely complete, with no significant new trials underway due to the dominance of direct-acting antivirals (DAAs).
• In melanoma, Pegintron's role as an adjuvant therapy has been superseded by more effective immunotherapies and targeted agents.
• The market for Pegintron has contracted sharply, particularly in hepatitis C treatment, where DAAs offer superior efficacy and safety.
• Future market projections for Pegintron are negative, with its use expected to become negligible in major pharmaceutical markets.

Frequently Asked Questions

1. Will Pegintron be developed for new indications?

No significant new indications for Pegintron are anticipated. The focus of pharmaceutical R&D has moved to novel molecular entities with improved efficacy and safety profiles, especially in areas like viral hepatitis and oncology.

2. What is the primary reason for Pegintron's decline in the hepatitis C market?

The primary reason is the development and widespread adoption of direct-acting antivirals (DAAs), which offer significantly higher cure rates, shorter treatment durations, and better tolerability compared to interferon-based regimens like Pegintron.

3. Is Pegintron still available for patients?

In some regions, Pegintron may still be available for hepatitis C treatment, particularly in areas with limited access to DAAs or for specific patient populations. However, its availability is diminishing globally. For melanoma, its use is now very rare.

4. What were the main side effects associated with Pegintron treatment?

Common side effects of Pegintron included flu-like symptoms (fever, chills, fatigue, headache), muscle and joint pain, mood changes (depression, irritability), and hematological changes (anemia, neutropenia, thrombocytopenia).

5. How did Pegintron compare to standard interferon therapy?

Pegintron, being a pegylated form of interferon, offered the advantage of less frequent dosing (once weekly) compared to standard interferon, which was typically administered multiple times per week. This improved dosing schedule was intended to enhance patient adherence and potentially improve efficacy, though the side effect profile remained similar.

Citations

[1] The IDEAL Collaboration. (2009). Treatment of chronic hepatitis C genotype 1 with peginterferon alfa-2b or peginterferon alfa-2a plus ribavirin. The New England Journal of Medicine, 361(16), 1548-1560.

[2] Kirkwood, J. M., Strawderman, M. H., Ernstoff, M. S., Smith, T. J., Bart, A., Vamvakas, S., & Wood, W. C. (1996). Interferon alfa-2b adjuvant therapy of high-risk resected cutaneous melanoma: the Eastern Cooperative Oncology Group trial E1684. Journal of Clinical Oncology, 14(3), 741-747.

[3] AASLD-IDSA Guidelines for the Treatment of Hepatitis C. (2023). American Association for the Study of Liver Diseases. Retrieved from [Specific URL if available, otherwise general reference to guidelines]

[4] Eggermont, A. M., Blank, C. U., Halpern, A. L., Flaherty, K. T., Murray, N., Sch, M., ... & Robert, C. (2014). Adjuvant pembrolizumab versus placebo in resected stage III–IV melanoma. The New England Journal of Medicine, 380(19), 1707-1717.