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↗	A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C	Withdrawn	Janssen Scientific Affairs, LLC	Phase 4	2014-08-01	This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and simeprevir in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↗	A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C	Withdrawn	University of California, San Francisco	Phase 4	2014-08-01	This is a study of the safety and effectiveness of the hepatitis C medications sofosbuvir and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.

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
Withdrawn	2
Terminated	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

OLYSIO (simeprevir) clinical trials update and market projection (2010–2026)
OLYSIO (simeprevir) is a direct-acting antiviral (DAA) NS3/4A protease inhibitor for chronic hepatitis C virus (HCV) infection. The drug’s clinical development is complete, with global uptake driven by genotype-restricted response patterns and eventual displacement by pan-genotypic regimens. From a 2026 decision standpoint, OLYSIO’s market is structurally limited to remaining treated populations under older guideline pathways, historical access programs, and pharmacy inventory depletion rather than new growth.

What is OLYSIO (simeprevir) and what clinical-trial readouts matter now?

OLYSIO is the brand of simeprevir, a once-daily NS3/4A protease inhibitor used in combination with pegylated interferon (PEG-IFN) and ribavirin (RBV) in earlier regimens, and later with sofosbuvir-based combinations for certain settings. Its development focus was sustained virologic response (SVR12) and characterization by baseline genotype (especially genotype 1), cirrhosis status, and prior treatment.

Why are SVR12 and genotype the dominant endpoints?

• SVR12 (undetectable HCV RNA at 12 weeks after end of treatment) is the primary efficacy endpoint used across pivotal programs for HCV DAAs.
• For simeprevir, genotype 1 baseline and subtype distribution influenced outcome distribution, including reduced expected performance in certain NS3 resistance contexts.

Which pivotal clinical trials established OLYSIO’s profile?

The development record includes multiple phase 2 and phase 3 programs across:

• Treatment-naïve and treatment-experienced genotype 1 patients
• Cirrhosis vs no cirrhosis
• Comparison against historical standard-of-care (PEG-IFN/RBV) and later DAAs

Core program names used in the regulatory package include:

• Trials evaluating simeprevir + PEG-IFN/RBV in genotype 1 settings
• Trials assessing simeprevir + sofosbuvir combinations for certain patient subsets

(See FDA approvals and label claims for the final approved uses and required combination regimens.) [1,2]

What is the clinical-trials status as of 2026?

• All pivotal programs for OLYSIO are completed.
• No new late-stage clinical development is material for new product differentiation because OLYSIO is no longer a growth platform in the pan-genotypic market.

How does OLYSIO perform in genotype 1 compared with later pan-genotypic DAA regimens?

What is the practical performance gap vs pan-genotypic standards?

Pan-genotypic combinations (notably sofosbuvir/velpatasvir and similar regimens) reduced the operational burden caused by genotype-based selection and improved convenience across prior-treatment and cirrhosis subgroups.

In commercial terms, this translated into:

• Lower treatment initiation for genotype-restricted protease inhibitor strategies
• Guideline shifts away from older interferon-containing combinations
• Reduced physician preference for drugs with conditional resistance or subtype constraints

OLYSIO’s value proposition was strongest during earlier DAA adoption, before the market converged on simplified all-oral pan-genotypic regimens.

What approvals exist for OLYSIO and what is the Orange Book status of simeprevir?

OLYSIO is an FDA-approved prescription drug. The relevant regulatory baseline is determined by:

• FDA label indications
• Orange Book listed patents for the approved NDA product (if any are listed as of the time of analysis)

No complete Orange Book patent listing data is provided in the input constraints, so patent-level exclusivity and launch barriers cannot be enumerated here without risking inaccuracies. The analysis below therefore focuses on clinical and market structure, not patent-by-patent freedom-to-operate.

What are the key FDA label features used in market access?

• Indication language is combination-driven (commonly with PEG-IFN/RBV in earlier labeling)
• Genotype-specific considerations appear in labeling and treatment algorithms (notably genotype 1 subtyping and resistance-associated considerations)

Source: FDA prescribing information for OLYSIO. [1,2]

When does OLYSIO lose exclusivity and what does that imply for future supply?

Patent-exclusivity timing cannot be computed here because patent numbers, filing/expiration, regulatory exclusivity (including pediatric exclusivity where applicable), and Orange Book status are not supplied in the prompt. A timing-based projection at the patent level would risk being wrong.

At a drug-market level, the practical reality is that simeprevir has been in the market long enough that new-entry risk is less about “when exclusivity ends” and more about:

• Generic penetration already occurring in historical markets
• Continued substitution by newer pan-genotypic DAAs that avoid protease inhibitor constraints and interferon

What generic entry risks exist for OLYSIO?

What drives generic risk for an older DAA?

• Once pan-genotypic regimens dominate, payer and physician formularies typically prefer newer fixed-dose combinations.
• Generic risk to OLYSIO is therefore not the typical “growth capture” question. Instead, it is margin erosion on any residual demand that remains.

What residual demand channels exist?

• Patients treated under older regimens due to payer coverage rules
• Availability through inventory in certain geographies
• Historical clinical practice inertia where protocols have not updated fully

What does OLYSIO’s market analysis show: demand base, payer behavior, and competitive displacement?

Market structure shift: protease-inhibitor era to pan-genotypic era

OLYSIO is in the class that rose during early interferon-sparing DAA adoption and then declined as:

• Interferon-free pan-genotypic regimens became the default
• Simplicity of therapy reduced genotype testing workflows
• Treatment curves shifted toward shorter, better-tolerated oral combinations

Competitive set that displaced simeprevir (commercially)

Key commercial displacers include DAAs that:

• Are pan-genotypic
• Are interferon-free
• Have high SVR rates with simplified genotype dependence

While OLYSIO can still be used in certain circumstances captured by label language, payer pathways largely consolidated around newer combinations.

What do revenue and volume projections look like for OLYSIO through 2026?

A defensible projection for OLYSIO through 2026 must be grounded in observed market substitution patterns rather than hypothetical growth.

Projection direction (2024–2026):

Last updated: July 27, 2026

• Flat-to-declining unit demand: residual treatment volumes shrink as newer regimens remain preferred.
• Margin compression: increased competitive pressure from generic DAAs and substitution to newer brands.
• Market access narrowing: formulary and prior-authorization criteria favor newer regimens.

Because no numeric sales or unit data is provided in the prompt, the projection is stated only in directional terms.

Which geographic markets matter most for OLYSIO now?

Where will residual use persist?

• Markets with slower guideline update cycles
• Systems with reimbursement structures that lag new DAA adoption
• Regions where procurement cycles or tender terms still reference older regimens

Where will residual use decline faster?

• Markets where pan-genotypic guidelines are already standardized and interferon-based pathways are de-emphasized

This geographic split is consistent with typical DAA life-cycle patterns after pan-genotypic consolidation.

What formulation and regimen factors affected adoption for OLYSIO?

How regimen design constrained broad uptake

Earlier standard approaches using simeprevir depended on combination partners (including PEG-IFN/RBV in older labeling). That creates:

• More side-effect burden relative to interferon-free options
• Higher monitoring and treatment discontinuation risk
• Lower attractiveness in real-world practice after interferon-free regimens became available

What is the operational implication for prescribers?

Even when SVR12 is high in trials, the practical adoption depends on:

• Treatment simplification and tolerability
• Clinical workflow fit (baseline testing, resistance testing where applicable, genotype constraints)

What clinical safety findings are most relevant for commercial use?

FDA labeling reports adverse reactions consistent with combination interferon-era therapy and protease inhibitor class effects. In commercial practice, safety determines persistence when patients need to complete therapy without dose reductions or discontinuation.

Primary product label references for:

• Adverse reactions
• Contraindications
• Drug-drug interaction warnings are the main sources that have shaped payer and physician risk management. [1,2]

How does OLYSIO’s R&D legacy affect today’s hepatitis C landscape?

OLYSIO’s development is now best viewed as:

• Part of the stepping-stone phase that validated NS3/4A protease inhibition
• A bridge toward interferon-free combinations by informing resistance biology and regimen design

This legacy matters for:

• New protease inhibitor development in HCV resistance strategy
• Competitive positioning analysis for companies building next-generation DAAs

Key Takeaways

• OLYSIO (simeprevir) is a completed clinical program with established SVR12 efficacy in genotype 1 settings, but its growth thesis ended when pan-genotypic, interferon-free DAAs consolidated standard-of-care.
• 2024–2026 expectations are structurally flat-to-declining demand, driven by guideline-driven substitution rather than manufacturing or utilization constraints.
• Patent/exclusivity and Orange Book status cannot be accurately enumerated from the provided input, so a timing or patent-freedom projection is not presented.

FAQs

1. Is OLYSIO still recommended in 2026 hepatitis C treatment guidelines?
2. What patient subgroups have the most remaining OLYSIO use (cirrhosis, prior treatment, genotype 1 subtypes)?
3. How do drug-drug interactions in the OLYSIO label affect real-world prescribing?
4. How does simeprevir compare with sofosbuvir/velpatasvir in SVR12 and treatment simplicity?
5. What does the shift to pan-genotypic DAAs mean for the protease-inhibitor class pipeline?

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References

1. U.S. Food and Drug Administration. Olysio (simeprevir) prescribing information. FDA label. [Accessed via FDA drug label database].
2. U.S. Food and Drug Administration. Drug Approval Package: OLYSIO (simeprevir). FDA.