CLINICAL TRIALS PROFILE FOR FUZEON

All Clinical Trials for FUZEON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	AIDS Clinical Trials Group	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00050856 ↗	Fuzeon (Enfuvirtide) Early Access Program for Patients With HIV-1 Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2002-11-01	This study will determine the safety and tolerability of Fuzeon (enfuvirtide) used together with other treatments for HIV infection in patients with advanced HIV disease. Fuzeon is an antiretroviral drug. Unlike other antiretrovirals, however, which work against the virus once it is already in the cell, Fuzeon prevents the virus from getting into healthy cells. Patients 18 years of age and older with advanced HIV-1 infection, who do not respond to approved antiretroviral therapy, may be eligible for this study. Candidates must have a CD4 lymphocyte count less than 100 cells/mm3 and a viral load greater than 10,000 copies/mL. They will be screened with a medical history, physical examination, and blood tests, and may also have an electrocardiogram (ECG), chest x-ray and urine test. Patients enrolled in the study will be re-examined and have additional blood tests before beginning treatment with Fuzeon. They will then be taught how to self-inject the medicine under the skin and will take two doses daily (less than 1/4 teaspoon each), 12 hours apart. After the first treatment, participants will have follow-up visits at weeks 1, 2, 4, 8, 12, 24, 36, 48, and every 12 weeks after that, if necessary, until 12 weeks after the drug becomes commercially available. Visits may be scheduled more often if a problem arises. During the follow-up visits, patients will have blood drawn, and their blood pressure, pulse rate and temperature will be checked. They will also report any drug side effects they have experienced. Patients may continue to take Fuzeon as long as they benefit from therapy and do not experience severe side effects from the treatment. The drug will be provided to participants until 12 weeks after it is sold in the United States.
NCT00086710 ↗	Study of Enfuvirtide in HIV-Positive Subjects	Completed	Hoffmann-La Roche	Phase 1	1969-12-31	A total of 26 patients will be admitted to the clinic where they will be dosed with each injection device. There will be a 7-day washout between doses and a 7-10 day follow-up period.

Clinical Trial Conditions for FUZEON

Condition Name

Condition Name for FUZEON
Intervention	Trials
HIV Infections	22
AIDS	2
Antiretroviral Treatment	1
HIV	1

Condition MeSH

Condition MeSH for FUZEON
Intervention	Trials
HIV Infections	22
Infections	8
Infection	8
Communicable Diseases	5

Clinical Trial Locations for FUZEON

Trials by Country

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Trials by Country for FUZEON
Location	Trials
United States	118
France	5
Puerto Rico	5
Canada	4
Australia	2

Trials by US State

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−

Trials by US State for FUZEON
Location	Trials
California	9
Florida	8
Maryland	7
Texas	7
New York	7

Clinical Trial Progress for FUZEON

Clinical Trial Phase

Clinical Trial Phase for FUZEON
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for FUZEON
Clinical Trial Phase	Trials
Completed	18
Unknown status	3
Terminated	2

Clinical Trial Sponsors for FUZEON

Sponsor Name

Sponsor Name for FUZEON
Sponsor	Trials
Hoffmann-La Roche	17
Trimeris	6
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for FUZEON
Sponsor	Trials
Industry	28
Other	9
NIH	7

Fuzeon: Clinical Trials, Market Analysis, and Projections

Introduction to Fuzeon

Fuzeon, also known as enfuvirtide or T-20, is the first FDA-approved HIV fusion inhibitor. It was developed by Trimeris and Roche, and approved in 2003 for the treatment of advanced HIV-1 infection in adults and children aged 6 years and older, in combination with other anti-HIV medications[5].

Clinical Trials Overview

Efficacy and Safety

The clinical efficacy of Fuzeon was established through two main studies, TORO 1 and TORO 2, involving approximately 1,013 patients aged 16 years or older who had been treated with or were not responding to other antiviral medicines. These studies compared the effects of Fuzeon combined with optimized background therapy (a combination of other antiviral medicines) versus optimized background therapy alone. The primary measure of effectiveness was the change in HIV viral load after 48 weeks of treatment.

• In the first study, viral loads fell by an average of 98% in patients taking Fuzeon, compared to 83% in those not taking Fuzeon.
• In the second study, the corresponding values were 96% and 78%, respectively[1].

Side Effects and Administration

Fuzeon is administered via subcutaneous injection twice daily, which has been a significant factor in its limited appeal due to the frequency and discomfort associated with injections. The most common side effects include injection-site reactions (reported in 98% of patients), peripheral neuropathy, and weight loss. These reactions are typically mild to moderate and occur primarily within the first week of treatment[1].

Pediatric Studies

Fuzeon has also been studied in children aged between 3 and 16 years, with ongoing studies at the time of its assessment. The approved dose in children achieves similar blood levels of the active substance as in adults[1].

Market Analysis

Current Market Status

The global market for fusion inhibitors, which includes Fuzeon, is driven by several key factors:

• Increasing Prevalence of HIV and Other Viral Infections: The rising incidence and prevalence of HIV and other viral infections globally are major drivers. According to the World Health Organization (WHO), around 38 million people worldwide are living with HIV[3].

• Ongoing Clinical Trials: Various companies are conducting clinical trials to develop and test new fusion inhibitors, which is expected to expand the market[3].

• Emergence of COVID-19 Treatment: Although not directly related to Fuzeon, the use of fusion inhibitors like remdesivir in treating COVID-19 has highlighted the potential of this class of drugs in treating viral infections[3].

Pricing and Accessibility

The launch of Fuzeon was marked by controversy due to its high price. The drug was priced at around £12,800 annually in Europe, significantly higher than other antiretroviral drugs. This pricing has been a point of contention, with critics arguing that it could lead to public health system chaos and restrict access to the drug for many patients[5].

Manufacturing and Distribution

Initially, the production of Fuzeon was limited due to its complex manufacturing process, which requires 106 chemical steps, ten times more than typical drugs. However, increased manufacturing capacity has addressed some of these limitations, allowing for expanded commitment to Fuzeon[4].

Market Projections

Growth of Fusion Inhibitors Market

The global fusion inhibitors market, which includes Fuzeon and other drugs like ibalizumab and fostemsavir, is projected to grow significantly:

• The market size was estimated to be around $294 million in 2021 and is projected to reach $7.5 billion by 2032[3].

Future Developments and Improvements

Roche and Trimeris have been focusing on the development of next-generation fusion inhibitors with improved efficacy and delivery methods. This includes researching ways to extend the half-life of the drug, such as attaching it to proteins or immunoglobulins, and exploring once-daily, once-weekly, or once-monthly administration regimens[4].

Challenges and Limitations

Administration Frequency

The twice-daily injection regimen of Fuzeon has been a significant drawback, affecting patient adherence and willingness to use the drug. Efforts to develop a once-daily regimen and other improved delivery methods are ongoing[4].

Cost and Accessibility

The high cost of Fuzeon remains a major barrier to its widespread use. The drug's pricing has been criticized for being excessive and potentially harmful to public health systems[5].

Key Takeaways

• Clinical Efficacy: Fuzeon has shown significant efficacy in reducing HIV viral loads when combined with optimized background therapy.
• Side Effects: Common side effects include injection-site reactions, peripheral neuropathy, and weight loss.
• Market Growth: The global fusion inhibitors market is expected to grow substantially, driven by increasing prevalence of HIV and ongoing clinical trials.
• Future Developments: Next-generation fusion inhibitors with improved delivery methods are being developed to address current limitations.
• Cost and Accessibility: The high cost of Fuzeon remains a significant challenge, impacting its accessibility and use.

FAQs

What is Fuzeon and how is it used?

Fuzeon, or enfuvirtide, is an HIV fusion inhibitor used in combination with other antiviral medications to treat advanced HIV-1 infection. It is administered via subcutaneous injection twice daily.

What are the common side effects of Fuzeon?

Common side effects include injection-site reactions (pain and inflammation), peripheral neuropathy, and weight loss.

Why is Fuzeon so expensive?

Fuzeon is expensive due to its complex manufacturing process, which requires more ingredients and processing steps than typical drugs. The high development costs and the need for a decent return on investment also contribute to its pricing.

Are there any next-generation fusion inhibitors being developed?

Yes, companies like Roche and Trimeris are working on next-generation fusion inhibitors with improved efficacy and delivery methods, such as once-daily or once-weekly administration regimens.

How does the market for fusion inhibitors look in the future?

The global market for fusion inhibitors is projected to grow significantly, reaching $7.5 billion by 2032, driven by increasing prevalence of HIV and ongoing clinical trials.

Sources

1. European Medicines Agency (EMA). Fuzeon.
2. BCC Research. Nuclear Fusion and Advanced Materials: Emerging Opportunities.
3. KD Market Insights. Fusion Inhibitors Market Size, Industry Growth, Forecast and Analysis.
4. NATAP. Update on Fuzeon and T-1249 Fusion Inhibitor Halted Development.
5. AIDSmap. Fuzeon fury: price of first FDA-approved HIV fusion inhibitor sparks protest in US.