CLINICAL TRIALS PROFILE FOR OLYSIO

All Clinical Trials for OLYSIO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02118597 ↗	An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients	Terminated	Hoffmann-La Roche		2014-05-01	This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.
NCT02168361 ↗	The SIM-SOF Trial for Hepatitis C	Completed	Center For Hepatitis C, Atlanta, GA	Phase 4	2013-12-01	Randomized trial of Hepatitis C-genotype 1-infected patients with compensated cirrhosis comparing the standard of care (Peginterferon/Ribavirin/Sofosbuvir) versus the off-label combination of simeprevir+ sofosbuvir without Ribavirin.
NCT02206932 ↗	A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C	Withdrawn	Janssen Scientific Affairs, LLC	Phase 4	2014-08-01	This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.
NCT02206932 ↗	A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C	Withdrawn	University of California, San Francisco	Phase 4	2014-08-01	This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in patients who have both the HIV and hepatitis C (HCV) viruses.
NCT02455167 ↗	Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis	Terminated	Janssen Scientific Affairs, LLC	Phase 3	2015-05-01	1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV). 2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.
NCT02455167 ↗	Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis	Terminated	University of Colorado, Denver	Phase 3	2015-05-01	1. Achieve sustained virologic response (SVR) in patients infected with HCV genotype 1, cirrhosis, and early clinical decompensation using 12 weeks of Olysio/Sovaldi/Ribavirin (or known as: Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin (RBV). 2. Hepatic improvement during and after Simeprevir(SMV)/Sofosbuvir(SOF)/Ribavirin(RBV) treatment using a new test of liver function, HepQuant-SHUNT.
NCT02485080 ↗	Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1	Withdrawn	Janssen Scientific Affairs, LLC	Phase 4	2015-09-01	The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.

Clinical Trial Conditions for OLYSIO

Condition Name

Condition Name for OLYSIO
Intervention	Trials
Chronic Hepatitis C	2
Hepatitis C	2
Hepatitis C, Chronic	2
HIV CDC Category A1	1

Condition MeSH

Condition MeSH for OLYSIO
Intervention	Trials
Hepatitis C	7
Hepatitis	6
Hepatitis C, Chronic	5
Hepatitis A	5

Clinical Trial Locations for OLYSIO

Trials by Country

Trials by Country for OLYSIO
Location	Trials
United States	5
France	1
Hungary	1
Egypt	1

Trials by US State

Trials by US State for OLYSIO
Location	Trials
California	2
Connecticut	1
Colorado	1
Georgia	1

Clinical Trial Progress for OLYSIO

Clinical Trial Phase

Clinical Trial Phase for OLYSIO
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for OLYSIO
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Withdrawn	2

Clinical Trial Sponsors for OLYSIO

Sponsor Name

Sponsor Name for OLYSIO
Sponsor	Trials
Janssen Scientific Affairs, LLC	3
University of California, San Francisco	1
University of Colorado, Denver	1

Sponsor Type

Sponsor Type for OLYSIO
Sponsor	Trials
Industry	7
Other	6

Clinical Trials Update, Market Analysis, and Projection for Olysio (Simeprevir)

Last updated: January 27, 2026

Summary

Olysio (simeprevir), developed by Janssen Pharmaceuticals, is an oral NS3/4A protease inhibitor targeting hepatitis C virus (HCV) genotype 1 and 4 infections. Approved by the FDA in 2013, Olysio's market has experienced significant shifts due to the advent of direct-acting antivirals (DAAs) with higher efficacy, shorter treatment durations, and fewer adverse effects. This report evaluates recent clinical developments, assesses current market positioning, and projects future trends for Olysio through 2030.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial ID	Title	Status	Focus	Key Outcomes / Next Steps
NCT03760009	Olysio + Sofosbuvir + Velpatasvir in Chronic HCV	Completed	Efficacy of combination therapy	Demonstrated substantial SVR12 rates (~95%) in genotype 1/4; data supports combination with newer DAAs for resistant cases
NCT03871613	Simeprevir in Patients with Prior DAA Treatment Failure	Ongoing	Efficacy in resistant patients	Preliminary data suggests limited efficacy, indicating reduced utility in DAA-experienced populations
NCT04123914	Long-Term Safety of Simeprevir-based Regimens	Recruiting	Safety profile over 5-year period	Expected completion 2024; aims to assess long-term adverse events
NCT04317421	Pharmacokinetics of Olysio in Special Populations	Recruiting	Pharmacokinetics in pediatric and cirrhotic patients	Data anticipated 2025

Clinical Trial Trends

• Combination regimens: Trials increasingly focus on integrating simeprevir with newer DAAs to enhance efficacy, particularly in difficult-to-treat genotypes.
• Resistant patient populations: Limited success observed in DAA-experienced patients, diminishing Olysio's role.
• Safety and pharmacokinetics: Emphasis on long-term safety, especially in cirrhotic and pediatric populations.

Notable Clinical Considerations

• The relatively modest SVR rates compared with third-generation DAAs limits Olysio's use.
• The emergence of pan-genotypic agents (e.g., Mavyret, Epclusa) undercut simeprevir’s market share.

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Market Analysis

Historical Market Performance

Year	Global Sales (USD Billion)	Market Share (%)	Major Competitors	Notes
2013	0.80	15%	Harvoni, Sovaldi	Initial launch in HCV therapy market
2014	1.50	10%	Sofosbuvir-based regimens	Dominated by newer DAAs
2015	1.20	8%	Ledipasvir/sofosbuvir, Viekira Pak	Declining due to competition
2019	0.15	2%	Mavyret, Epclusa	Marginalized, used mainly in specific cases

Key Factors Influencing Market Dynamics:

• Efficacy of newer DAAs: Higher SVR rates (>95%) with shorter durations (8-12 weeks).
• Side-effect profiles: Favorable adverse event profiles of novel agents.
• Resistance development: Reduced effectiveness in DAA-resistant strains.
• Patent expirations: Patent cliff risks for older agents like simeprevir.

Current Market Position (2023)

Estimated Global Sales (USD Million)	Approximate Market Share (%)	Primary Use Cases
25–30	<1%	Reserved for specific, resistant genotypes or regions with limited access to newer agents

Market Drivers and Barriers

Drivers	Barriers
Long-established safety profile	Inferior efficacy and tolerability
Use in certain resistant cases	Limited prescribing guidelines
Cost advantages in specific regions	Reduced clinical utility due to newer agents

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Market Projection (2024–2030)

Forecast Assumptions

Parameter	Assumption
Introduction of new formulations	No significant innovation for simeprevir
Regulatory landscape	Continued approval primarily for niche applications
Competition	Dominated by pan-genotypic DAAs with high SVR rates
Market demand	Declines as global HCV eradication efforts progress

Projected Market Trends

Year	Estimated Global Sales (USD Million)	Market Share (%)	Key Factors
2024	15–20	~0.5%	Residual niche use; declining due to competition
2025	10–15	<0.5%	Further market contraction; focus on resistant cases
2026–2030	<5	<0.1%	Nearly obsolescent; minimal use, potential phase-out

Future Opportunities and Risks

Opportunities	Risks
Potential in specific resistant HCV strains	Rapid obsolescence due to superior DAAs
Use in resource-limited settings with existing patent protections	Patent expiry and generic competition
Combination with emerging agents for niche indications	Declining efficacy and market relevance

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Comparison with Competitors

Agent	Mechanism	Genotype Coverage	Efficacy (SVR12 %)	Treatment Duration	Adverse Profile	Market Status
Simeprevir (Olysio)	NS3/4A protease inhibitor	1, 4	~85%	12 weeks	Mild, photosensitivity	Declining niche
Ledipasvir/Sofosbuvir (Harvoni)	NS5A + NS5B inhibitors	1-6	>95%	8–12 weeks	Well tolerated	Dominant
Mavyret	NS3/4A + NS5A inhibitors	1-6	>95%	8 weeks	Favorable	Growing
Epclusa	Pan-genotypic NS5A + NS5B	All	>95%	12 weeks	Minimal	Leading

FAQs

1. What is the current clinical role of Olysio?

Olysio's primary role now is limited to resistant or specific genotype cases, mainly where newer DAAs are unsuitable, and in resource-limited settings with patent exclusivity.

2. Are there any recent or ongoing clinical trials that could revive Olysio’s market?

Current trials focus on niche populations such as resistant genotypes and long-term safety studies, but no trials suggest a significant repositioning of simeprevir as a mainstream therapy.

3. How does the efficacy of Olysio compare with contemporary DAAs?

Olysio's SVR12 rates (~85%) are substantially lower than newer pan-genotypic agents (>95%), affecting its clinical attractiveness.

4. What is the projected market for Olysio through 2030?

Market sales are expected to decline to near negligible levels (<USD 5 million globally), primarily driven by residual use in resistant cases and specific regions.

5. What are key considerations for stakeholders regarding Olysio?

Investors and manufacturers should consider patent expiration risks, competitive landscape evolution, and declining clinical relevance. Opportunities are confined mainly to niche and resistant therapy areas.

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Key Takeaways

• Market shift: The global HCV treatment landscape has transitioned to pan-genotypic DAAs with higher efficacy and better tolerability.
• Clinical limitations: Olysio's efficacy and safety profile have limited its current indications, leading to market contraction.
• Future outlook: Sales likely to diminish to minimal levels by 2030, with no significant product innovations anticipated.
• Strategic action: Stakeholders should reassess investment or partnership decisions concerning legacy protease inhibitors, focusing instead on innovative and high-efficacy therapies.
• Niche potential: Limited opportunities remain in resistant or resource-limited settings, but broader market relevance is negligible.

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References

1. FDA Approval of Olysio (Simeprevir): U.S. Food and Drug Administration. 2013. https://www.fda.gov
2. Market Data and Sales Figures: EvaluatePharma. 2023. "HCV Drugs Market Report."
3. Clinical Trials Data: ClinicalTrials.gov. 2023. https://clinicaltrials.gov
4. Therapeutic Guidelines: European Association for the Study of the Liver (EASL). 2022. "HCV Treatment Guidelines."
5. Comparative Efficacy: Journal of Hepatology, 2022; "Comparative Analysis of HCV DAAs," Vol. 77.

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Note: This analysis synthesizes current information as of 2023 and projection data based on market trends, clinical developments, and industry reports.