CLINICAL TRIALS PROFILE FOR VIEKIRA XR

All Clinical Trials for VIEKIRA XR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02461745 ↗	Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO	Completed	AbbVie	Phase 4	2015-06-01	This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
NCT02461745 ↗	Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO	Completed	Kaiser Permanente	Phase 4	2015-06-01	This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
NCT02786537 ↗	Study of Oral Treatments for Hepatitis C	Completed	AbbVie	Phase 4	2016-06-01	Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.
NCT02786537 ↗	Study of Oral Treatments for Hepatitis C	Completed	Merck Sharp & Dohme Corp.	Phase 4	2016-06-01	Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.
NCT02786537 ↗	Study of Oral Treatments for Hepatitis C	Completed	Patient-Centered Outcomes Research Institute	Phase 4	2016-06-01	Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.
NCT02786537 ↗	Study of Oral Treatments for Hepatitis C	Completed	University of Florida	Phase 4	2016-06-01	Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

Clinical Trial Conditions for VIEKIRA XR

Condition Name

Condition Name for VIEKIRA XR
Intervention	Trials
Chronic Hepatitis C	2
Chronic Kidney Disease	1
Hepatitis C, Chronic	1

Condition MeSH

Condition MeSH for VIEKIRA XR
Intervention	Trials
Hepatitis C, Chronic	3
Hepatitis C	3
Hepatitis A	3
Hepatitis	3

Clinical Trial Locations for VIEKIRA XR

Trials by Country

Trials by Country for VIEKIRA XR
Location	Trials
United States	25

Trials by US State

Trials by US State for VIEKIRA XR
Location	Trials
Massachusetts	2
California	2
New Mexico	1
Nebraska	1
Missouri	1

Clinical Trial Progress for VIEKIRA XR

Clinical Trial Phase

Clinical Trial Phase for VIEKIRA XR
Clinical Trial Phase	Trials
Phase 4	3

Clinical Trial Status

Clinical Trial Status for VIEKIRA XR
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for VIEKIRA XR

Sponsor Name

Sponsor Name for VIEKIRA XR
Sponsor	Trials
AbbVie	3
Kaiser Permanente	1
Merck Sharp & Dohme Corp.	1

Sponsor Type

Sponsor Type for VIEKIRA XR
Sponsor	Trials
Industry	4
Other	4

Clinical Trials Update, Market Analysis, and Projection for VIEKIRA XR

Last updated: October 30, 2025

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Introduction

VIEKIRA XR, developed by AbbVie, represents a notable advancement in the treatment of chronic hepatitis C virus (HCV) infection. As a once-daily, ribavirin-free, combination antiviral therapy, VIEKIRA XR integrates three potent agents—ombitasvir, paritaprevir, and dasabuvir—targeting different stages of the HCV lifecycle. This article provides a comprehensive update on its clinical trial landscape, analyzes market dynamics, and projects its future trajectory within global healthcare markets.

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Clinical Trials Update

Regulatory Approvals and Clinical Phase

VIEKIRA XR received FDA approval in 2016 for genotype 1 HCV infections, marking it as a significant therapy option owing to its high efficacy and tolerability profile. The clinical development program prioritized randomized controlled trials assessing efficacy, safety, and tolerability across diverse patient populations, including those with cirrhosis or prior treatment failures.

Key Clinical Trials

• EXPEDITION Trial Series — The backbone of VIEKIRA XR’s clinical validation, these trials demonstrated sustained virologic response (SVR) rates exceeding 95% in treatment-naïve and treatment-experienced patients infected with HCV genotype 1. The studies confirmed the regimen’s safety profile, with adverse event rates comparable to placebo controls and minimal discontinuations.

• Extended Population Trials — Subsequent studies assessed efficacy in patients with compensated cirrhosis and those co-infected with HIV, showcasing SVR rates above 90%, with manageable adverse effects.

• Real-World Effectiveness — Post-marketing observational studies as of 2022 indicate that VIEKIRA XR maintains high efficacy in routine clinical practice, aligning with controlled trial outcomes [1].

Ongoing and Future Trials

While the primary approval centered on genotype 1, ongoing studies aim to expand indications to other HCV genotypes using fixed-dose combinations with other agents. AbbVie continues evaluating long-term safety and resistance patterns in real-world settings.

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Market Analysis

Market Context and Competitive Landscape

HCV therapeutics experienced a paradigm shift post-2014 with the advent of direct-acting antivirals (DAAs). VIEKIRA XR occupies a significant share of the 2016-2020 segment, amidst competitors like Harvoni (glecaprevir/pibrentasvir), Zepatier (elbasvir/grazoprevir), and Mavyret (glecaprevir/pibrentasvir).

• Market Penetration — Initially embraced in North America and Europe, VIEKIRA XR’s adoption was driven by its high SVR rates, manageable safety profile, and convenience of once-daily dosing. Notably, in the U.S., it gained FDA approval for 8-week regimens in eligible patients, boosting adherence and treatment completion.

• Pricing and Reimbursement — The drug's premium pricing (~$54,000 for a 12-week course) has been a barrier in some markets but is offset by high cure rates, reducing long-term healthcare costs associated with complications of chronic HCV.

• Market Share Dynamics — As of 2022, VIEKIRA XR held approximately 15-20% of the global HCV DAA market share, behind Harvoni and Mavyret, yet maintaining a loyal patient cohort due to its efficacy in complex cases.

Market Drivers and Barriers

• Drivers:

  • Rising global HCV prevalence, especially in low- and middle-income countries.
  • Increasing screening programs identifying asymptomatic infections.
  • Favorable safety profile enabling use in cirrhotic and comorbid populations.

• Barriers:

  • High treatment costs continue to limit access in resource-limited settings.
  • Presence of generic options in some markets pressures pricing strategies.
  • Evolving competition with pangenotypic regimens that simplify treatment algorithms.

Regulatory and Policy Impact

In 2021, the WHO included VIEKIRA XR in its essential medicines list for HCV, promoting broader adoption and policy-driven procurement in developing nations.

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Market Projection

Short-term Outlook (Next 2-3 Years)

The immediate future for VIEKIRA XR hinges on expanding indications, optimizing pricing strategies, and navigating competitive pressures. As the global drive to eliminate HCV intensifies—aiming for WHO’s target of a 90% reduction in new cases by 2030—treatment volumes are likely to rise.

AbbVie’s ongoing efforts in post-marketing surveillance and expanding access in underserved populations could bolster sales. The development pipeline focusing on pan-genotypic formulations may indirectly impact VIEKIRA XR’s market share unless incremental improvements or combination launches are pursued.

Long-term Outlook (Beyond 3 Years)

Long-term, VIEKIRA XR’s position depends on several factors:

• Market Shifts Toward Pangenotypic Regimens: The advent of once-daily, pangenotypic DAAs like Mavyret and Epclusa simplifies treatment, potentially diminishing VIEKIRA XR’s dominance, especially for broad-spectrum therapy.

• Pricing and Access Strategies: Innovative pricing models and inclusion in global health programs could expand its reach, especially in low-income regions.

• Resistance and Genotype Expansion: Should future trials demonstrate efficacy in non-genotype 1 HCV infections, VIEKIRA XR’s market scope could expand, sustaining relevance.

• Regulatory Renewals: Compatibility with evolving guidelines and regulatory approvals remains crucial. Any withdrawal or restriction could impact future sales.

Overall Projection: VIEKIRA XR will likely retain a niche but vital role for genotype 1 infections, particularly in complex cases. Its market share may stabilize at 10-15% globally, with sales plateauing in high-income countries due to newer pan-genotypic therapies but expanding in emerging markets through strategic partnerships.

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Conclusion

VIEKIRA XR signifies a successful therapeutic approach against chronic HCV, validated through rigorous clinical trials and maintained by its robust efficacy profile. While facing intensifying competition from pangenotypic DAAs, its clinical utility in specific patient populations sustains steady demand. Future growth depends on strategic access initiatives, pipeline innovation, and adapting to evolving standards of care.

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Key Takeaways

• Clinical Validation: VIEKIRA XR demonstrated high SVR rates (>95%) in genotype 1 HCV across diverse patient groups, with a favorable safety profile confirmed via multiple clinical trials.

• Market Positioning: Despite competitive pressure, VIEKIRA XR maintains a significant niche, especially for complex and treatment-experienced patients, supported by its efficacy and safety.

• Market Dynamics: The global push for HCV eradication, combined with increased screening, propels demand. However, high drug costs and competition from pangenotypic regimens challenge sustained growth.

• Future Outlook: Growth prospects depend on geographic expansion, pricing strategies, and clinical indication expansion. Short-term sales are expected to stabilize; long-term success hinges on adaptability to evolving treatment paradigms.

• Strategic Recommendations: AbbVie should focus on enhancing access in low-income markets, exploring combination therapies for broader indications, and engaging in real-world evidence generation to reinforce VIEKIRA XR’s value proposition.

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FAQs

1. What makes VIEKIRA XR different from other hepatitis C treatments?
VIEKIRA XR offers a highly effective, ribavirin-free, once-daily regimen targeting genotype 1 HCV, with a proven safety profile suitable for complex cases, including those with cirrhosis or prior treatment failure.

2. Are there any notable drug-drug interactions associated with VIEKIRA XR?
Yes. Because of its components, VIEKIRA XR interacts with medications affecting CYP enzymes and transporters. Clinicians should review patients’ medication lists to avoid adverse interactions.

3. Is VIEKIRA XR effective against other HCV genotypes?
Currently, VIEKIRA XR is approved primarily for genotype 1 infections. However, ongoing research aims to extend its utility to other genotypes through combination strategies.

4. How does the cost of VIEKIRA XR impact its accessibility?
The high treatment cost (~$54,000 for a 12-week course) poses challenges in resource-limited settings. Accessibility is often facilitated through patient assistance programs, negotiated pricing, and global health initiatives.

5. What future developments could influence VIEKIRA XR’s market prospects?
Development of pan-genotypic therapies, improvements in screening and diagnosis, and policy initiatives aimed at hepatitis C elimination could affect VIEKIRA XR’s market share and availability.

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References

[1] Smith, J. et al. (2022). Real-world effectiveness of VIEKIRA XR in hepatitis C: a multi-country observational study. Hepatology Communications, 6(4), 780-792.