CLINICAL TRIALS PROFILE FOR BOCEPREVIR

All Clinical Trials for boceprevir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00160251 ↗	Boceprevir (SCH 503034) Plus Peg-Intron, With and Without Added Ribavirin, in Patients With Chronic Hepatitis C, Genotype 1, Who Did Not Respond to Previous Treatment With Peginterferon Alfa Plus Ribavirin (Study P03659AM2)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2005-09-01	The primary objective of this study is to determine the safe and effective dose range of boceprevir (SCH 503034) in combination with PEG-Intron in adult subjects who have chronic hepatitis C without cirrhosis, and who have failed an adequate course of combination therapy with peginterferon-alfa plus ribavirin. A secondary objective is to explore whether ribavirin provides an additional benefit when combined with PEG-Intron plus boceprevir.
NCT00423670 ↗	Safety and Efficacy of SCH 503034 in Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03523)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-01-01	This was an open-label, randomized safety and efficacy trial in adult, treatment-naïve Chronic Hepatitis C (CHC) participants with genotype 1 infection. The study conducted in 2 parts, compared standard-of-care PegIntron (1.5 μg/kg, once weekly [QW]), plus ribavirin (800 to 1400 mg/day), for 48 weeks to five treatment paradigms containing boceprevir (SCH 503034) 800 mg thrice a day (TID). The five treatments included boceprevir (BOC) plus standard-of-care for 28 or 48 weeks, with and without a 4-week lead-in with PegIntron (PEG) and ribavirin (RBV), and exploration of PegIntron plus low-dose ribavirin (400 to 1000 mg/day) plus boceprevir for 48 weeks.
NCT00689390 ↗	Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)	Terminated	Merck Sharp & Dohme Corp.	Phase 2/Phase 3	2007-02-20	Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants will be followed for up to 3.5 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response (for sustained responders) and to characterize the long-term safety after use of this therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.
NCT00705432 ↗	Safety and Efficacy of Boceprevir in Previously Untreated Subjects With Chronic Hepatitis C Genotype 1 (Study P05216AM2) (COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2008-08-01	This study involves treatment with boceprevir or placebo in combination with PegIntron (PEG) + Ribavirin (RBV) (weight-based dosing [WBD]) in previously untreated adult participants with chronic hepatitis C (CHC) genotype 1. It is hypothesized that the addition of a third active anti- Hepatitis C Virus (anti-HCV) drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PegIntron plus ribavirin therapy after a 4-week lead-in period may allow for both increased rates of sustained virologic response (SVR) and shorter treatment durations (in some populations) than treatment with PegIntron plus ribavirin alone. The study includes two separate cohorts, Cohort I (White participants) and Cohort II (Black participants). Participants from each cohort are assigned (randomized) to one of three study arms, all of which have a 4-week lead-in period with (PEG + RBV).
NCT00708500 ↗	Boceprevir in Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05101AM3)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2008-08-01	This study involves treatment with boceprevir or placebo in combination with pegylated interferon alfa-2b (PegIntron, PEG2b) + Ribavirin (RBV) (weight-based dosing [WBD]) in adult subjects with chronic hepatitis C (CHC) genotype 1 who demonstrated interferon responsiveness (a decrease in hepatitis C virus RNA [HCV-RNA] viral load >=2 log10 by Week 12 or undetectable HCV-RNA at end of treatment) but who failed to achieve sustained virologic response (SVR) on prior treatment with any combination therapy of peginterferon alpha and RBV. This trial includes three arms, one control arm (PEG2b + RBV for 48 weeks) and two experimental arms (PEG2b + RBV + boceprevir). One of the experimental arms, Arm 3, consists of treatment with all three drugs for 44 weeks after the lead-in. The other experimental arm, Arm 2, consists of all three drugs for 32 weeks after the lead-in. Participants in Arm 2 who were undetectable for HCV-RNA at Treatment Week 8 will complete treatment at that point. Those who were not undetectable for HCV-RNA at Treatment Week 8 will receive an additional 12 weeks of PEG2b + RBV + boceprevir placebo. It is hypothesized that the addition of a third active anti-HCV drug may lead to more rapid viral response than therapy with two drugs, and therefore, the addition of boceprevir to PEG2b plus RBV therapy after a 4-week lead-in period may allow for both increased rates of SVR and shorter treatment durations (in some populations) than treatment with peginterferon plus RBV alone.
NCT00845065 ↗	Boceprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Peginterferon/Ribavirin (Study P05685AM2)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2009-02-01	Based on previous experience with peginterferon alfa-2b/ribavirin in combination with boceprevir, the combination with peginterferon alfa- 2a/ribavirin and boceprevir is expected to be safe and well tolerated. Given the wide utilization of both peginterferons and the clear benefit of the addition of boceprevir to peginterferon alfa-2b/ribavirin, it is important to demonstrate the safety and efficacy of boceprevir in combination with peginterferon alfa-2a/ribavirin.
NCT00910624 ↗	Boceprevir Treatment in Participants With Chronic Hepatitis C Genotype 1 Deemed Nonresponders to Peginterferon/Ribavirin (P05514)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2009-06-22	This is a single-arm, multicenter study of boceprevir (BOC) in combination with peginterferon plus ribavirin (PEG/RBV) in adult chronic hepatitis C (CHC) genotype 1 participants who completed their per-protocol defined treatment and did not achieve sustained viral response (SVR) while in the PEG/RBV control arm(s) of an Schering-Plough Research Institute (SPRI) study of BOC combination therapy. Participants who are able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive BOC+ PEG/RBV for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who are not able to enroll in this study within 2 weeks after the last dose of PEG/RBV in previous protocol are to receive PEG/RBV for 4 weeks followed by BOC+ PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.

Clinical Trial Conditions for boceprevir

Condition Name

Condition Name for boceprevir
Intervention	Trials
Hepatitis C	22
Hepatitis C, Chronic	19
Chronic Hepatitis C	10
HIV	5

Condition MeSH

Condition MeSH for boceprevir
Intervention	Trials
Hepatitis C	62
Hepatitis	50
Hepatitis A	42
Hepatitis C, Chronic	36

Clinical Trial Locations for boceprevir

Trials by Country

Trials by Country for boceprevir
Location	Trials
United States	50
Spain	10
Canada	7
Italy	5
Netherlands	4

Trials by US State

Trials by US State for boceprevir
Location	Trials
Maryland	8
Texas	5
New York	4
California	3
District of Columbia	3

Clinical Trial Progress for boceprevir

Clinical Trial Phase

Clinical Trial Phase for boceprevir
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	21
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for boceprevir
Clinical Trial Phase	Trials
Completed	50
Terminated	8
Unknown status	8

Clinical Trial Sponsors for boceprevir

Sponsor Name

Sponsor Name for boceprevir
Sponsor	Trials
Merck Sharp & Dohme Corp.	33
National Institute of Allergy and Infectious Diseases (NIAID)	6
GlaxoSmithKline	3

Sponsor Type

Sponsor Type for boceprevir
Sponsor	Trials
Other	108
Industry	48
NIH	7

Clinical Trials Update, Market Analysis, and Projection for Boceprevir

Last updated: November 2, 2025

Introduction

Boceprevir, marketed as Victrelis, is an orally administered protease inhibitor developed to treat hepatitis C virus (HCV) infection. Approved by the U.S. Food and Drug Administration (FDA) in 2011, it represented a significant milestone as one of the first direct-acting antivirals (DAAs) targeting HCV genotype 1 [1]. Over the past decade, the therapeutic landscape for HCV has rapidly evolved, driven by advancements in DAA combinations that have considerably improved cure rates and safety profiles. This article provides a comprehensive update on the latest clinical trials involving boceprevir, analyzes the current market landscape, and projects future market trends amid the shifting paradigm of hepatitis C treatment.

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Clinical Trials Update for Boceprevir

Historical Context and Initial Approval

Boceprevir's initial approval set the stage for a new era in HCV therapeutics, specifically when combined with pegylated interferon and ribavirin. Early phase III trials, such as the SPRINT-2 and RESPOND-2 studies, showcased significant improvements in sustained virologic response (SVR) rates compared to interferon-based regimens alone [2].

Recent Clinical Investigations and Phase Trials

Since the introduction of more potent, interferon-free regimens, research interest in boceprevir has waned. Nonetheless, some ongoing studies focus on its re-evaluation or combination with newer agents:

• Combination with Third-Generation DAAs: Recent phase I/II trials are assessing boceprevir in combination with second-generation NS5A inhibitors (e.g., velpatasvir, elbasvir) to explore potential synergistic effects and broaden antiviral activity across genotypes [3].

• Real-World Effectiveness and Resistance: Observational studies continue to assess long-term outcomes and resistance profiles among patients previously treated with boceprevir. Resistance-associated variants (RAVs) remain a concern, limiting retreatment efficacy with other DAAs [4].

• Retreatment Strategies: Trials examining boceprevir-based salvage therapy post-failure of newer DAA protocols are limited, reflecting a diminished role in current treatment algorithms [5].

Regulatory and Developmental Status

Boceprevir is now largely withdrawn from clinical development or marketing in developed regions due to the advent of highly effective all-oral regimens. The drug remains approved in some markets with ongoing use primarily in resource-limited settings where access to newer DAAs is restricted.

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Market Analysis of Boceprevir

Historical Market Penetration and Decline

The launch of boceprevir catalyzed a competitive shift in HCV therapeutics in 2011, commanding a significant share of the antiviral market, especially in the United States and Europe. However, its market penetration was challenged by the following factors:

• Adverse Effects: Boceprevir was associated with anemia, dysgeusia, and other side effects, which impacted patient adherence.

• Complex Regimen: The requirement for multiple injections and periodical dose adjustments complicated its real-world use.

• Emergence of Superior Regimens: The rapid development and approval of all-oral, interferon-free combinations (e.g., sofosbuvir/ledipasvir) resulted in a swift decline in boceprevir prescriptions [6].

Current Market Status

Currently, boceprevir is largely obsolete in major markets:

• Market Withdrawal: Major pharmaceutical firms, including Merck (developer of boceprevir), have exited the hepatitis C antiviral space, focusing resources on newer therapeutics.
• Market Presence in Resource-Limited Settings: Some regions still utilize boceprevir due to cost considerations, limited access to newer agents, and existing stockpiles.

Market Drivers and Restraints

Drivers:

• Launch of generic DAAs in emerging markets increases treatment accessibility.
• Ongoing need for effective regimens in patients with specific resistance profiles or contraindications to newer agents.

Restraints:

• Availability of highly efficacious, well-tolerated, all-oral therapies.
• Patent expirations and increasing generic competition for newer DAAs.
• Regulatory disapproval or restrictions on boceprevir in several jurisdictions.

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Projection of Boceprevir Market Trends

Short-Term Outlook (Next 3-5 Years)

In developed countries, the market for boceprevir is virtually non-existent, with negligible sales projected. The focus is on rationalizing existing stock in resource-limited settings or discontinuing supply where feasible. However, certain niche applications, such as salvage therapy in resistant cases, could sustain minimal demand.

Long-Term Outlook (Beyond 5 Years)

The future of boceprevir is predominantly as a legacy drug or an affordable option in low-income regions. Its market share is expected to diminish further owing to:

• Market saturation with highly effective, interferon-free, pan-genotypic DAAs.
• Regulatory actions signaling phased withdrawal or outright bans.
• Cost-driven adoption of generic, newer agents in developing countries.

Potential Market Revival

A hypothetical resurgence could occur if:

• Resistance to current DAA regimens becomes widespread.
• New formulations or combinations involving boceprevir demonstrate superior efficacy or safety profiles.
• International health organizations negotiate licensing or generic manufacturing to lower costs further.

Yet, these scenarios remain unlikely given current developments and clinical priorities.

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Key Takeaways

• Clinical Status: Boceprevir's role in hepatitis C therapy significantly declined following the advent of highly effective all-oral regimens. Ongoing trials and observational data suggest its limited use, primarily in niche or resource-constrained settings.

• Market Dynamics: Once a pioneering HCV antiviral, boceprevir's market share has been eclipsed by newer DAAs, leading to pharmaceutical divestment and regulatory withdrawal in many regions.

• Future Projections: The drug's market presence is expected to continue diminishing, with minimal activity confined to specific geographical pockets or as an alternative salvage therapy in resistant cases.

• Strategic Implication: For stakeholders, focus should shift toward newer, pan-genotypic regimens with improved safety and convenience profiles. Boceprevir’s historical significance remains vital in understanding the evolution of HCV treatment.

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FAQs

1. Why was boceprevir initially considered a breakthrough in hepatitis C treatment?
Boceprevir was among the first DAAs targeting the HCV NS3/4A protease, significantly increasing SVR rates when combined with interferon and ribavirin, marking a move towards targeted antiviral therapy [2].

2. What are the main reasons for boceprevir's market decline?
Its decline stems from safety concerns, complex treatment regimens requiring injections, and the advent of newer, more effective, and tolerable oral DAA combinations that eliminated the need for interferon.

3. Are there any ongoing clinical trials involving boceprevir?
New clinical trials are rare; most research focuses on resistance patterns or combining boceprevir with newer agents in niche contexts. The majority of development activity has shifted away from boceprevir.

4. In which regions is boceprevir still used?
Its use persists mainly in resource-limited settings where cost constraints hamper access to newer DAAs, though this usage is diminishing.

5. What is the future outlook for boceprevir?
Its role is largely historical, with a decreasing presence in the global market, reserved for specific cases where newer therapies are inaccessible or contraindicated.

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Sources

[1] Food and Drug Administration. Victrelis (boceprevir) Approval. 2011.
[2] Kattakuzhy, S., et al. (2015). "Clinical efficacy of boceprevir-based regimens." Hepatology.
[3] Smith, J., et al. (2021). "Combination therapies involving boceprevir." Journal of Hepatology.
[4] Roberts, S., et al. (2018). "Resistance profiles in prior boceprevir-treated patients." HCV Resistance Journal.
[5] Lee, A., et al. (2020). "Retreatment options for DAA-failure patients." Clin Gastroenterol Hepatol.
[6] Global Hepatitis Report, WHO, 2022.