CLINICAL TRIALS PROFILE FOR VICTRELIS

All Clinical Trials for Victrelis

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00959699 ↗	A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected With HIV and Hepatitis C (P05411 AM4)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2009-11-01	The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b) 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV) (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virus (HCV) genotype 1. Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit viral replication in HCV-infected host cells. The mechanism of inhibition represents a new mechanism of action compared to both interferon alfa and ribavirin. Based on previous experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected population, this combination treatment is expected to provide significant benefit to the HIV/HCV coinfected population. Given the high unmet medical need of these participants and the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants coinfected with HIV/HCV. This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via a crossover arm.
NCT01353911 ↗	Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)	Completed	Merck Sharp & Dohme Corp.	Phase 2	2011-06-27	This study will evaluate the safety, tolerability, and antiviral activity of grazoprevir (MK-5172) when administered in combination with peginterferon alfa-2b (Peg-IFN) and ribavirin (RBV) in treatment-naïve (TN) participants with chronic hepatitis C.
NCT01390844 ↗	Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2011-10-21	This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population. The primary hypothesis is that the proportion of participants achieving sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.
NCT01465516 ↗	Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir	Terminated	Arrowhead Regional Medical Center		2011-11-01	Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.
NCT01471717 ↗	Study to Evaluate the Pharmacokinetics and Safety of INX-08189 Administered With VictrelisTM in Healthy Subjects	Completed	Bristol-Myers Squibb	Phase 1/Phase 2	2011-10-01	This study is designed to evaluate the potential for a pharmacokinetic drug-drug interaction between INX-08189 and Victrelis, a Direct Acting Antiviral (DAA).
NCT01912495 ↗	Dutch Acute HCV in HIV Study (DAHHS)	Completed	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Phase 2	2013-08-01	Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4. The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.
NCT01912495 ↗	Dutch Acute HCV in HIV Study (DAHHS)	Completed	Maastricht University Medical Center	Phase 2	2013-08-01	Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4. The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.

Clinical Trial Conditions for Victrelis

Condition Name

Condition Name for Victrelis
Intervention	Trials
Hepatitis C, Chronic	4
Hepatitis C	2
Hepatitis C Infection	2
Hepatitis C,	1

Condition MeSH

Condition MeSH for Victrelis
Intervention	Trials
Hepatitis C	8
Hepatitis	7
Hepatitis A	6
Hepatitis C, Chronic	4

Clinical Trial Locations for Victrelis

Trials by Country

Trials by Country for Victrelis
Location	Trials
United States	3
Netherlands	2
Hungary	1

Trials by US State

Trials by US State for Victrelis
Location	Trials
Ohio	1
Minnesota	1
California	1

Clinical Trial Progress for Victrelis

Clinical Trial Phase

Clinical Trial Phase for Victrelis
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	3
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Victrelis
Clinical Trial Phase	Trials
Completed	6
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for Victrelis

Sponsor Name

Sponsor Name for Victrelis
Sponsor	Trials
Merck Sharp & Dohme Corp.	4
Maastricht University Medical Center	1
Onze Lieve Vrouwe Gasthuis	1

Sponsor Type

Sponsor Type for Victrelis
Sponsor	Trials
Other	11
Industry	6
U.S. Fed	1

VICTRELIS (Boceprevir): Clinical Trials, Market Analysis, and Projections

Introduction

VICTRELIS, also known as boceprevir, is an oral HCV NS3/4A protease inhibitor developed by Merck for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Phase IIb Clinical Study for HCV/HIV Coinfection

A significant clinical trial involved evaluating the efficacy of VICTRELIS in combination with peginterferon alfa-2b and ribavirin for treating patients coinfected with chronic HCV genotype 1 and HIV-1. This Phase IIb study included 100 patients and showed that 60.7% of patients receiving VICTRELIS in combination with peginterferon alfa-2b and ribavirin achieved a sustained virologic response 12 weeks after treatment (SVR-12), compared to 26.5% of patients receiving peginterferon alfa-2b and ribavirin alone[1].

DYNAMO 1 Trial

Another notable trial is the DYNAMO 1 study, a Phase II clinical trial that evaluates the use of VICTRELIS in combination with mericitabine, Pegasys (pegylated interferon alfa-2a), and Copegus (ribavirin) in adult patients with chronic HCV genotype 1 infection who had a null response to prior peginterferon alfa and ribavirin therapy. This study aims to recruit patients at 25 sites globally and is part of the collaboration between Merck and Roche to explore novel combination therapies[3].

Efficacy and Safety

Sustained Virologic Response

The clinical trials have consistently shown that VICTRELIS, when used in combination with peginterferon alfa and ribavirin, significantly increases the likelihood of achieving SVR-12. For example, in the Phase IIb study for HCV/HIV coinfected patients, the SVR-12 rate was 34.2% higher in the VICTRELIS treatment arm compared to the control arm[1].

Safety Profile

Preliminary safety data from these studies indicate that the safety profile of VICTRELIS in combination therapy is similar to that observed in patients with HCV mono-infection. However, there were instances of HIV breakthrough in some patients, highlighting the need for careful monitoring in coinfected patients[1].

Market Analysis

Approval and Launch

VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011, for the treatment of chronic HCV genotype 1 infection in combination with peginterferon alfa and ribavirin. Merck partnered with Roche to promote VICTRELIS, leveraging their existing market presence and marketing muscle[2].

Pricing and Revenue

At the time of its launch, VICTRELIS was priced at $1,100 per week wholesale, or $26,400-$48,400 annually. Despite being priced lower than its competitor Incivek (telaprevir), VICTRELIS faced stiff competition. Analysts predicted peak worldwide sales of $2.0 billion for VICTRELIS in 2015, compared to $2.7 billion for Incivek[2].

Market Projections

The global market for boceprevir (VICTRELIS) was estimated to be worth $32 million in 2023 and is forecasted to reach $46 million by 2030, with a compound annual growth rate (CAGR) of 5.3% during the forecast period 2024-2030. This growth is modest, reflecting the evolving landscape of HCV treatments and the emergence of newer therapies[5].

Key Players and Competitive Landscape

The market for boceprevir includes several key players such as Lan Pharmatech, Excenen Pharmatech, BioCrick, Shimadzu Group, CSNpharm, and Selleck Chemicals. These companies are involved in the production and distribution of boceprevir, contributing to the overall market size and growth[5].

Public Awareness and Disease Education

Merck and Roche have also focused on public awareness and disease education as part of their marketing strategy for VICTRELIS. This includes supporting initiatives to raise awareness about hepatitis C and the importance of early diagnosis and treatment[2].

Indications and Usage

VICTRELIS is indicated for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy. It must be used in combination with peginterferon alfa and ribavirin and not as monotherapy[3].

Challenges and Future Directions

Resistance and Non-Response

Patients who are poorly interferon responsive or have previously failed therapy with peginterferon alfa and ribavirin have a lower likelihood of achieving SVR with VICTRELIS. This highlights the need for ongoing research into new combination therapies and strategies to overcome resistance[4].

Collaborative Studies

Merck's collaboration with Roche and other organizations, such as the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and the AIDS Clinical Trial Group (ACTG), is crucial for evaluating the potential role of VICTRELIS in different patient populations and exploring novel treatment regimens[1].

Key Takeaways

• Clinical Efficacy: VICTRELIS significantly improves SVR rates when used in combination with peginterferon alfa and ribavirin.
• Safety Profile: The safety profile is generally consistent with that of HCV mono-infection, but careful monitoring is needed in coinfected patients.
• Market Performance: Despite competitive pressures, VICTRELIS has a forecasted market size of $46 million by 2030.
• Indications: It is indicated for chronic HCV genotype 1 infection in combination with peginterferon alfa and ribavirin.
• Future Directions: Ongoing research and collaborative studies are essential for optimizing treatment outcomes and addressing resistance.

FAQs

What is VICTRELIS used for?

VICTRELIS (boceprevir) is used for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in combination with peginterferon alfa and ribavirin.

When was VICTRELIS approved by the FDA?

VICTRELIS was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2011.

How does VICTRELIS compare to other HCV treatments?

VICTRELIS was priced lower than its competitor Incivek but had a lower SVR rate. However, it remains a viable option due to its efficacy in combination therapy.

What are the key challenges in using VICTRELIS?

Key challenges include the potential for resistance and breakthrough, particularly in poorly interferon responsive patients, and the need for careful monitoring in coinfected patients.

What is the forecasted market size for VICTRELIS by 2030?

The forecasted market size for VICTRELIS by 2030 is $46 million, with a CAGR of 5.3% during the forecast period 2024-2030.

Who are the main players in the boceprevir market?

The main players include Lan Pharmatech, Excenen Pharmatech, BioCrick, Shimadzu Group, CSNpharm, and Selleck Chemicals.

Sources

1. Merck Press Release: Results from Investigational Studies with VICTRELIS™ (boceprevir) Presented at the Conference on Retroviruses and Opportunistic Infections[1].
2. MM+M: Victrelis - MM+M - Medical Marketing and Media[2].
3. Merck Press Release: Merck Announces Initiation of Clinical Development Collaboration with Roche To Evaluate Investigational Combination Regimens for the Treatment of Chronic Hepatitis C Genotype 1 Infection[3].
4. FDA Label: VICTRELIS (boceprevir) Label[4].
5. Valuates Reports: Boceprevir - Market, Report Size, Worth, Revenue, Growth, Industry[5].