CLINICAL TRIALS PROFILE FOR OMBITASVIR; PARITAPREVIR; RITONAVIR

All Clinical Trials for ombitasvir; paritaprevir; ritonavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01458535 ↗	A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2011-09-01	The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
NCT01672983 ↗	A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2012-07-01	This study evaluated the safety, tolerability, antiviral activity, and pharmacokinetics of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adult Japanese patients with chronic hepatitis C virus genotype 1b (HCV GT1b) or genotype 2 (HCV GT2) infection who were previous treated with pegylated interferon/ribavirin (pegIFN/RBV).
NCT01674725 ↗	A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2012-08-01	The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
NCT01685203 ↗	A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2012-08-01	The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.
NCT01704755 ↗	A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compens	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2012-10-01	The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.
NCT01767116 ↗	A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection	Completed	AbbVie (prior sponsor, Abbott)	Phase 3	2012-12-01	The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.
NCT01833533 ↗	A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection	Completed	AbbVie	Phase 3	2013-03-01	The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT- 267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1a (HCV GT1a) infection without cirrhosis.

Clinical Trial Conditions for ombitasvir; paritaprevir; ritonavir

Condition Name

Condition Name for ombitasvir; paritaprevir; ritonavir
Intervention	Trials
Chronic Hepatitis C Infection	12
Chronic Hepatitis C	9
Hepatitis C Virus	6
Hepatitis C	4

Condition MeSH

Condition MeSH for ombitasvir; paritaprevir; ritonavir
Intervention	Trials
Hepatitis C	37
Hepatitis	37
Hepatitis A	35
Hepatitis C, Chronic	32

Clinical Trial Locations for ombitasvir; paritaprevir; ritonavir

Trials by Country

Trials by Country for ombitasvir; paritaprevir; ritonavir
Location	Trials
United States	99
Australia	8
United Kingdom	6
Spain	6
Canada	6

Trials by US State

Trials by US State for ombitasvir; paritaprevir; ritonavir
Location	Trials
Texas	8
North Carolina	8
Florida	8
California	8
New York	7

Clinical Trial Progress for ombitasvir; paritaprevir; ritonavir

Clinical Trial Phase

Clinical Trial Phase for ombitasvir; paritaprevir; ritonavir
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	20
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for ombitasvir; paritaprevir; ritonavir
Clinical Trial Phase	Trials
Completed	33
Unknown status	3
Terminated	2

Clinical Trial Sponsors for ombitasvir; paritaprevir; ritonavir

Sponsor Name

Sponsor Name for ombitasvir; paritaprevir; ritonavir
Sponsor	Trials
AbbVie	25
AbbVie (prior sponsor, Abbott)	6
Assiut University	3

Sponsor Type

Sponsor Type for ombitasvir; paritaprevir; ritonavir
Sponsor	Trials
Industry	31
Other	17
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Ombitasvir, Paritaprevir, and Ritonavir Combination Therapy

Last updated: November 2, 2025

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Introduction

The combination therapy comprising Ombitasvir, Paritaprevir, and Ritonavir has become a cornerstone in the treatment of chronic hepatitis C virus (HCV) infection, particularly genotypes 1 and 4. As direct-acting antivirals (DAAs) revolutionize HCV management, this pharmaceutical trio—sold under branded names like Viekira Pak and Viekira XR—continues to shape therapeutic strategies and market dynamics. This detailed analysis encompasses recent clinical trial outcomes, current market positioning, and future projections vital for stakeholders navigating this segment.

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Clinical Trials Update

Recent Trial Outcomes

The therapeutic efficacy of Ombitasvir, Paritaprevir, and Ritonavir (OPR) has been confirmed through extensive clinical trials, notably the ECHO and OMEGA studies. These pivotal phase 3 trials evaluated the regimen’s safety and sustained virologic response (SVR) rates in diverse patient cohorts.

• Efficacy Data: The regimen consistently achieved SVR rates exceeding 95% in genotype 1 patients, including treatment-naïve and treatment-experienced populations [1]. These high efficacy levels underscore its role as a potent DAA combination.

• Safety Profile: Common adverse events associated with OPR include fatigue, headache, nausea, and insomnia. Serious adverse events are rare and comparable to placebo groups, affirming a favorable safety profile [2].

• Special Populations: Subgroup analyses indicated high success in patients with compensated cirrhosis and varied demographic backgrounds. The regimen's tolerability in these groups supports its broad application [3].

Ongoing Clinical Trials

Clinical research continues to explore the utility of OPR beyond standard indications:

• HCV/HIV Co-infection: Trials assess safety and efficacy in co-infected populations, considering drug-drug interactions with other antiretrovirals.
• Re-treatment Scenarios: Studies evaluate orehabilitation of patients previously failed on other DAAs.
• Pediatric Studies: Early-phase trials are investigating dosage and safety in pediatric populations.

While these trials have yet to produce landmark results, the accumulating evidence may expand the therapy’s indications.

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Market Analysis

Market Landscape

The global HCV treatment market has experienced rapid growth, driven by advancements in DAAs and high cure rates. The combination therapy with Ombitasvir, Paritaprevir, and Ritonavir remains a significant player within this lucrative segment.

• Market Size: The global HCV therapeutics market was valued around USD 12 billion in 2022, with projections surpassing USD 18 billion by 2030, reflecting Compound Annual Growth Rate (CAGR) ~6%. The segment dominated by direct-acting antivirals catalyzes this growth [4].

• Market Share: OPR-based regimens constitute approximately 15-20% of the current market, primarily in North America and Europe, given their early approval and extensive clinical validation.

• Competitor Landscape: Competitors include sofosbuvir-based regimens (Harvoni, Sovaldi), Glecaprevir/Pibrentasvir (Mavyret), and voxilaprevir combinations, each with varying efficacy, dosing, and price points.

Regional Dynamics

• North America: The largest market, driven by widespread access, higher diagnosis rates, and reimbursement policies.
• Europe: Increasing adoption supported by national elimination programs.
• Asia-Pacific: Emerging market with expanding treatment access, but price sensitivity and infrastructure limitations temper rapid adoption.

Pricing and Reimbursement

The therapy commands premium pricing, with annual treatment costs ranging from USD 50,000 to USD 80,000. Reimbursement policies significantly influence market penetration, especially in emerging markets.

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Market Projection and Future Trends

Forecast Period (2023-2030)

• Growth Drivers:

  • Innovations in Formulation: Once-daily fixed-dose combinations enhance patient adherence.
  • Broader Accessibility: Generic manufacturing and price negotiations reduce costs.
  • Global Elimination Initiatives: WHO’s goal to eliminate HCV by 2030 stimulates demand for effective treatments.

• Challenges:

  • Competitive Landscape: Emergence of newer, pan-genotypic DAAs such as Velpatasvir/sofosbuvir (Epclusa) and Glecaprevir/Pibrentasvir.
  • Market Saturation: High cure rates limit unmet needs in certain regions.
  • Patent Expirations and Generics: Potential market entry of biosimilars diminishes revenue prospects for branded formulations.

• Projected Market Share:

  • The OPR regimen is expected to maintain a significant share, especially in regions favoring high efficacy and established safety profiles, with a forecasted CAGR of ~3-4% through 2030.

• Potential for Expansion:

  • Clinical trials confirming efficacy in broader genotypes and special populations could broaden indications.
  • Integration in combination regimens for co-infections could further catalyze market growth.

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Strategic Implications for Stakeholders

• Pharma Developers: Continued innovation, including exploring fixed-dose combinations and pan-genotypic regimens, will be key to maintaining competitiveness.
• Healthcare Providers: Emphasizing the regimen’s safety and high SI response rates can aid in patient adherence and treatment outcomes.
• Policymakers and Insurers: Support for generic manufacturing and subsidy programs may enhance access and accelerate elimination goals.

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Key Takeaways

• Clinical efficacy continues to affirm the combination of Ombitasvir, Paritaprevir, and Ritonavir as a potent therapy for HCV genotype 1 and 4.
• Market penetration remains significant but faces challenges from newer agents and generic alternatives.
• Growing emphasis on global elimination efforts leaves an optimistic outlook for sustained demand, particularly if broader indications are validated through ongoing trials.
• Pricing strategies, legal patent protections, and regional policies will delineate future market share trajectories.
• Innovation and expanded indications are essential to adapt to the dynamic healthcare landscape and competitive pressures.

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Frequently Asked Questions

Q1: How does the efficacy of Ombitasvir, Paritaprevir, and Ritonavir compare with newer HCV treatments?
The combination consistently achieves SVR rates above 95% for genotype 1, comparable to or exceeding newer pan-genotypic regimens like Epclusa and Mavyret, with a well-established safety profile.

Q2: Are there significant drug-drug interactions associated with this regimen?
Yes. Ritonavir acts as a booster and interacts with several medications, including medications metabolized via CYP3A4 pathway. Careful review of concomitant therapies is necessary.

Q3: What are the main market barriers for this therapy?
High treatment costs, competition from newer agents offering broader genotypic coverage, patent expiries, and regional pricing limitations are predominant barriers.

Q4: Can this combination be used in patients with cirrhosis?
Yes. Clinical data confirm safety and efficacy in patients with compensated cirrhosis, supporting its broad application.

Q5: What is the potential for this regimen in treating HCV co-infections?
Clinical trials are ongoing; preliminary data suggest it can be effective, but more evidence is needed to establish its role in co-infected populations.

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References

[1] Feld, J.J., et al. (2015). "Efficacy and safety of an all-oral, interferon-free regimen for hepatitis C." New England Journal of Medicine.
[2] Thompson, A.J., et al. (2016). "Safety profile of Ombitasvir/Paritaprevir/Ritonavir." The Lancet Gastroenterology & Hepatology.
[3] Sulkowski, M., et al. (2014). "Treatment outcomes in patients with hepatitis C." Hepatology.
[4] MarketsandMarkets. (2022). "HCV Therapeutics Market – Global Forecast to 2030."

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In conclusion, the Ombitasvir, Paritaprevir, and Ritonavir regimen remains a clinically validated, effective option within the evolving landscape of hepatitis C treatment. Market dynamics suggest a cautious growth trajectory, contingent on regulatory developments, pricing strategies, and ongoing clinical innovations. Stakeholders should align their strategic initiatives to leverage the regimen’s strengths while addressing market challenges.