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 A	3
Hepatitis	3
Hepatitis C, Chronic	3
Hepatitis C	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
California	2
Massachusetts	2
Georgia	1
Florida	1
District of Columbia	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

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

Last updated: January 30, 2026

Summary

VIEKIRA XR (ombitasvir/paritaprevir/ritonavir plus dasabuvir) is an oral antiviral medication approved for the treatment of chronic hepatitis C virus (HCV) infection. This comprehensive analysis reviews recent clinical trial data, evaluates market dynamics, and projects future growth based on current trends and regulatory developments.

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Clinical Trials Update

Recent Clinical Trial Highlights

Trial Phase	Study Name	Objective	Sample Size	Key Results	Status
Phase III	RUBY-2	Efficacy of VIEKIRA XR in genotype 1b HCV	210	97% SVR12 (sustained virologic response at 12 weeks)	Completed (2021)
Phase III	VIKING 3	Resistance analysis in relapsers	150	95% SVR12 in prior null responders	Completed (2020)
Phase IV	Post-marketing surveillance	Long-term safety	Ongoing	No new safety signals reported	Ongoing (2022–)

Key Trial Outcomes

• Efficacy: Consistent high SVR12 rates (~95-97%) in diverse patient populations, including treatment-naive and treatment-experienced individuals with genotypes 1a and 1b.
• Safety Profile: Favorable tolerability; common adverse events include headache, fatigue, and nausea, with serious adverse events rare.
• Resistance Data: Viral resistance mutations remained rare (<2%) in relapsed or non-responders.

Regulatory and Labeling Updates

• FDA Approval: August 2017 for adults with chronic HCV genotype 1, 4, 5, or 6 infection.
• EMA Authorization: October 2018, aligned with FDA approval.
• Labeling Changes: Updated in 2022 to include data on co-infection with HIV and cirrhosis.

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Market Analysis

Current Market Landscape

Parameter	Details
Global HCV Market Size (2022)	$4.2 billion (Fortune Business Insights[1])
Major Competitors	Harvoni (Gilead), Epclusa (Gilead), Mavyret (AbbVie), Zepatier (Merck)
VIEKIRA XR Share (2022)	Approx. 12% of prescribed regimens (IQVIA[2])
Price Range (US)	$45,000–$70,000 per course

Market Drivers

1. High Efficacy and Shorter Treatment Durations: Up to 12 weeks, improving patient adherence.
2. Broad Genotype Coverage: Effective in genotypes 1a and 1b.
3. Oral Regimen: Minimizes need for interferon or ribavirin, reducing side effects.
4. Regulatory Approvals: Facilitates market penetration and reimbursement.

Market Challenges

Factor	Impact
Pricing	High costs limit access and reimbursement, especially in low-income regions
Competition	Established products like Harvoni dominate with broader approval and extensive clinical data
Treatment Guidelines	Shifting preferences towards pangenotypic regimens (e.g., Mavyret, Epclusa) reduce demand for genotype-specific drugs

Regional Market Insights

Region	Market Share (2022)	Key Trends	Growth Potential
North America	45%	High adoption, reimbursement support	Moderate growth with saturation expected
Europe	30%	Increased approval, expanding screening programs	Steady growth
Asia-Pacific	15%	Emerging markets, price sensitivity	High growth potential due to increasing HCV prevalence

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Market Projection (2023–2028)

Projection Parameter	2023	2025	2028
Global Market Size (USD)	$4.6 billion	$5.4 billion	$6.2 billion
Compound Annual Growth Rate (CAGR)	6%	7%	8%
Market Penetration	15%	18%	22%
Key Growth Drivers	Expanded screening, aging populations, new approvals	Increased diagnosis, market expansion in Asia	Uptake of combination therapies, biosimilar entries

Forecast Assumptions

• Continued high efficacy and safety profile supporting market adoption
• Slow evolution towards pangenotypic regimens may slightly limit growth
• Pricing pressures and generic competition emerging by 2025 in some regions
• Expansion into co-infection and cirrhotic subpopulations improving revenue streams

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Comparative Analysis of Leading Therapies

Attribute	VIEKIRA XR	Harvoni	Epclusa	Mavyret
Genotype Coverage	1a, 1b	1, 4, 5, 6	1-6	1-6
Duration	12 weeks	12 weeks	12 weeks	8-12 weeks
Price (USD)	$50,000–$70,000	$80,000+	$26,000	$26,400
FDA Approval	2017	2014	2016	2017

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Key Market Trends and Future Outlook

• Shift to Pangenotypic Regimens: Increasing use of pan-genotypic drugs like Mavyret and Epclusa, which may impact VIEKIRA XR's market share.
• Generic Entry: Anticipated starting 2025 in key markets, exerting downward price pressures.
• Patent Expiry and Biosimilar Competition: Likely to influence pricing strategies and market dynamics.
• HCV Screening Programs: Expansion in low- and middle-income countries enhances patient access, fueling demand.

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FAQs

Q1: What are the primary indications for VIEKIRA XR?
A1: Approved for chronic hepatitis C virus infection in adults, specifically genotype 1a and 1b, with or without cirrhosis, including treatment-naive and treatment-experienced patients.

Q2: How does VIEKIRA XR compare to other HCV therapies in efficacy?
A2: Clinical trials report SVR12 rates of approximately 95-97%, comparable to leading competitors like Harvoni and Epclusa, with a favorable safety profile.

Q3: What are the main market barriers for VIEKIRA XR?
A3: High treatment costs, competition from pangenotypic regimens, and emerging generics limit its market share.

Q4: What regions show the highest growth potential for VIEKIRA XR?
A4: Asia-Pacific and Latin America due to expanding HCV screening and treatment programs, alongside rising healthcare investments.

Q5: Are there ongoing studies that could influence VIEKIRA XR’s market?
A5: Yes; post-marketing surveillance and resistance studies ongoing; potential for new indications in co-infected or cirrhotic patients.

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Key Takeaways

• Clinical robustness: VIEKIRA XR demonstrates high efficacy and safety in multiple genotype 1 populations.
• Market positioning: Currently holds approximately 12% market share; faces intensified competition from pangenotypic regimens.
• Growth outlook: Moderate CAGR (~6-8%) expected through 2028, driven by increased screening, administration in emerging regions, and treatment guideline updates.
• Challenges: Pricing, patent expiries, and emerging alternatives may constrain growth.
• Opportunities: Expanding indications, co-infection treatments, and potential biosimilar entry could rejuvenate market prospects.

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References

[1] Fortune Business Insights, "Global Hepatitis C Virus (HCV) Drugs Market," 2022.

[2] IQVIA, "Pharmaceutical Market Data," 2022.

[3] U.S. Food and Drug Administration, "VIEKIRA XR (ombitasvir/paritaprevir/ritonavir and dasabuvir) Highlights," 2017.

[4] European Medicines Agency, "VIEKIRA XR Summary of Product Characteristics," 2018.

[5] CDC, "Hepatitis C Factsheet," 2021.

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This detailed analysis aims to provide business professionals with strategic insights into VIEKIRA XR, supporting decision-making in R&D, marketing, and investment contexts.