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Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR HARVONI


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All Clinical Trials for Harvoni

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02339038 ↗ Community-based Treatment of Chronic Hepatitis C Monoinfection and Coinfection With HIV in the District of Columbia Completed National Institutes of Health Clinical Center (CC) Phase 4 2015-01-07 Background: - Treatment for Hepatitis C has changed a lot in the past 2 years. Most of this change comes from a combination of medicines that is yielding high cure rates. But its long-term effects are uncertain. One problem is that a lot of people need the treatment, but only a few specialists can give it. The success rate for Hepatitis C treatment by primary care doctors, nurse practitioners, or physician assistants is largely unknown. Researchers want to see how provider type affects treatment outcomes. They will conduct a large, community-based study in the District of Columbia. Objectives: - To see if people can be treated for Hepatitis C safely and successfully in community-based health centers. Eligibility: - Adults who need treatment for chronic Hepatitis C infection. Design: - Participants will be screened with blood tests. Their current medicines will be reviewed. - Participants will give researchers access to their medical records. Researchers will follow participants through these records. - Participants will see a primary care or infectious disease provider. The provider will tell them about their treatment. They will be told how often they will visit the provider and how often they will have their blood drawn. They will get a calendar of study visits. - Participants will take Harvoni for 8, 12, or 24 weeks. They will visit their care provider monthly. - Participants will have monthly follow-up visits for up to 3 months after they finish their medicine. - Participants will have yearly follow-up visits with their care provider for up to 10 years.
NCT02347345 ↗ Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs Completed National Institute on Drug Abuse (NIDA) Phase 4 2016-11-15 The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.
NCT02347345 ↗ Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs Completed Rockefeller University Phase 4 2016-11-15 The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.
NCT02480166 ↗ Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6 Completed Gilead Sciences Phase 4 2015-06-01 The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations
NCT02480166 ↗ Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6 Completed Stanford University Phase 4 2015-06-01 The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations
NCT02480387 ↗ Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 8 Weeks in Subjects With Chronic Genotype 1 HCV and HIV-1 Co-infection Completed Peter J. Ruane, M.D., Inc. Phase 2 2015-05-01 Target Population: Hepatitis C Treatment Naïve, non-cirrhotic, Chronic genotype 1 hepatitis C virus (HCV) infected adults that are co-infected with human immunodeficiency virus (HIV)-1and have HCV RNA < 6 x106 IU/mL Duration of Subjects will be treated for 8 weeks and followed for 24 weeks post- Treatment: treatment
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Harvoni

Condition Name

Condition Name for Harvoni
Intervention Trials
Hepatitis C 15
Chronic Hepatitis C 4
Hepatitis C, Chronic 3
Human Immunodeficiency Virus 2
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Condition MeSH

Condition MeSH for Harvoni
Intervention Trials
Hepatitis C 29
Hepatitis 29
Hepatitis A 22
Hepatitis C, Chronic 11
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Clinical Trial Locations for Harvoni

Trials by Country

Trials by Country for Harvoni
Location Trials
United States 62
Italy 6
Egypt 5
Canada 3
Korea, Republic of 2
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Trials by US State

Trials by US State for Harvoni
Location Trials
New York 8
California 7
Texas 5
District of Columbia 4
Pennsylvania 4
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Clinical Trial Progress for Harvoni

Clinical Trial Phase

Clinical Trial Phase for Harvoni
Clinical Trial Phase Trials
Phase 4 16
Phase 3 3
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Harvoni
Clinical Trial Phase Trials
Completed 21
Recruiting 3
Active, not recruiting 3
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Clinical Trial Sponsors for Harvoni

Sponsor Name

Sponsor Name for Harvoni
Sponsor Trials
Gilead Sciences 12
University of Maryland 3
National Institutes of Health Clinical Center (CC) 2
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Sponsor Type

Sponsor Type for Harvoni
Sponsor Trials
Other 59
Industry 17
NIH 7
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Clinical Trials, Market Analysis, and Projections for Harvoni

Introduction to Harvoni

Harvoni, a fixed-dose combination of ledipasvir and sofosbuvir, is a groundbreaking treatment for chronic hepatitis C virus (HCV) infection. Approved by the FDA in 2014, it has revolutionized the treatment landscape for HCV, offering high efficacy rates and a relatively short treatment duration.

Clinical Trials Update

Efficacy in Pediatric Patients

One of the significant clinical trials involving Harvoni is the Phase 2 study (GS-US-337-1116) that evaluated its safety and efficacy in pediatric patients. This study focused on adolescents aged 12 to <18 years with chronic HCV genotype 1 infection. The results were highly promising, with a sustained virologic response (SVR12) rate of 98% after a 12-week treatment regimen. This indicates that Harvoni is highly effective in treating HCV in adolescent patients without cirrhosis or with compensated cirrhosis[3][4].

Long-Term Outcomes and Safety

The ASCEND study, led by the NIH, is another crucial trial that aims to assess community-based HCV treatment outcomes, including the use of direct-acting antivirals like Harvoni. This study involves monitoring 600 adult D.C. residents over a 10-year period to evaluate long-term treatment outcomes, safety, and tolerance of the drug. It also examines whether the type of healthcare provider influences treatment outcomes and compares outcomes between patients with HCV alone and those co-infected with HCV and HIV[1].

Market Analysis

Global Hepatitis C Market Size and Growth

The global hepatitis C market, which includes drugs like Harvoni, is experiencing significant growth. As of 2024, the market size was estimated at USD 71.86 billion and is projected to reach USD 271.11 billion by 2034, growing at a CAGR of 14.2% from 2024 to 2034. North America is the largest market for hepatitis C drugs, driven by high prevalence rates and advanced healthcare infrastructure[2].

Market Share and Competition

Harvoni, developed by Gilead Sciences, has been a market leader in the HCV treatment segment. However, the launch of newer drugs like Mavyret by AbbVie has introduced competition. Mavyret offers a shorter treatment course and is more affordable, which has led to a shift in market dynamics. Despite this, Harvoni remains popular, especially in regions like India where it is more affordable and widely available[5].

Distribution Channels

The distribution of Harvoni and other HCV drugs is primarily through hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are the dominant channel due to the need for close medical supervision during HCV treatment. Retail and online pharmacies also play significant roles, especially in regions with well-developed healthcare systems[5].

Market Projections

Future Growth Drivers

The hepatitis C drugs market is expected to grow driven by several factors:

  • Increasing Prevalence: The global prevalence of HCV is rising, particularly in regions with limited access to safe blood transfusions and sterile medical equipment.
  • Regulatory Approvals: Continuous regulatory approvals for new and existing drugs will boost market growth.
  • Advancements in Treatment: The development of more effective and shorter treatment regimens will attract more patients and healthcare providers to the market[5].

Regional Market Growth

North America will continue to be a major market for HCV drugs, including Harvoni, due to its high prevalence rates and strong healthcare infrastructure. The Asia-Pacific and Latin American regions are also expected to see significant growth as healthcare access and awareness improve in these areas[2][5].

Challenges and Opportunities

Despite the positive projections, the market faces challenges such as the high cost of treatments, which can be a barrier in many regions. However, the introduction of more affordable options and the expansion of treatment to pediatric and harder-to-treat populations offer significant opportunities for growth.

"The rising number of regulatory approvals will further boost the market during the forecast time frame."[5]

Key Takeaways

  • High Efficacy: Harvoni has demonstrated high efficacy rates in both adult and pediatric patients with HCV.
  • Market Growth: The global hepatitis C market is projected to grow significantly, driven by increasing prevalence and regulatory approvals.
  • Competition: The market is competitive, with newer drugs like Mavyret challenging Harvoni's market share.
  • Regional Expansion: North America, Asia-Pacific, and Latin America are key regions for future market growth.
  • Affordability: The affordability of treatments remains a critical factor in market dynamics.

Frequently Asked Questions (FAQs)

1. What is Harvoni, and how does it treat HCV?

Harvoni is a fixed-dose combination of ledipasvir and sofosbuvir, used to treat chronic HCV infection by inhibiting the HCV NS5A and NS5B proteins, respectively.

2. What are the efficacy rates of Harvoni in pediatric patients?

Harvoni has shown a 98% SVR12 rate in pediatric patients aged 12 to <18 years with chronic HCV genotype 1 infection[3].

3. What are the main distribution channels for Harvoni?

The main distribution channels for Harvoni are hospital pharmacies, retail pharmacies, and online pharmacies[5].

4. How is the global hepatitis C market expected to grow?

The global hepatitis C market is expected to grow from USD 71.86 billion in 2024 to USD 271.11 billion by 2034, at a CAGR of 14.2%[2].

5. What are the challenges facing the hepatitis C drugs market?

The main challenges include the high cost of treatments and the need for continuous medical supervision, which can be barriers in many regions[5].

Sources:

  1. NIH-led study to assess community-based hepatitis C treatment in Washington, D.C. - NIH News Releases.
  2. Hepatitis C Market Size to Reach USD 271.11 Billion in 2034 - Precedence Research.
  3. Statistical Review and Evaluation (Harvoni) - FDA.
  4. 212477Orig1s000 - accessdata.fda.gov - FDA.
  5. Global Hepatitis C Drugs Market (2019 to 2025) - Business Wire.

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