CLINICAL TRIALS PROFILE FOR VIREAD

All Clinical Trials for Viread

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.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	HIV Prevention Trials Network	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00074581 ↗	Preventing Sexual Transmission of HIV With Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	2005-02-01	This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.
NCT00078182 ↗	Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia	Withdrawn	Kirby Institute	Phase 2/Phase 3	1969-12-31	Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.
NCT00078182 ↗	Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia	Withdrawn	NCHADS - Ministry of Health of Cambodia	Phase 2/Phase 3	1969-12-31	Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.

Clinical Trial Conditions for Viread

Condition Name

Condition Name for Viread
Intervention	Trials
Chronic Hepatitis B	21
Hepatitis B	16
HIV Infections	13
Hepatitis B, Chronic	7

Condition MeSH

Condition MeSH for Viread
Intervention	Trials
Hepatitis	56
Hepatitis B	54
Hepatitis A	48
Hepatitis B, Chronic	39

Clinical Trial Locations for Viread

Trials by Country

Trials by Country for Viread
Location	Trials
United States	169
Korea, Republic of	24
Thailand	14
Canada	12
China	9

Trials by US State

Trials by US State for Viread
Location	Trials
California	18
New York	13
Maryland	9
Florida	9
North Carolina	9

Clinical Trial Progress for Viread

Clinical Trial Phase

Clinical Trial Phase for Viread
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	14
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Viread
Clinical Trial Phase	Trials
Completed	52
Unknown status	14
Recruiting	11

Clinical Trial Sponsors for Viread

Sponsor Name

Sponsor Name for Viread
Sponsor	Trials
Gilead Sciences	14
Third Affiliated Hospital, Sun Yat-Sen University	8
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for Viread
Sponsor	Trials
Other	133
Industry	53
NIH	14

VIREAD: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to VIREAD

VIREAD, also known as tenofovir disoproxil fumarate (TDF), is a potent antiviral drug developed by Gilead Sciences. It is widely used in the treatment of HIV and has also been investigated for its efficacy in treating other viral infections, including hepatitis B.

Clinical Trials and Efficacy

HIV Treatment

VIREAD was first approved by the U.S. Food and Drug Administration (FDA) in October 2001 as an anti-HIV medication. It has since become a cornerstone in HIV treatment regimens. The drug is often used in combination with other antiretroviral therapies to manage HIV infection effectively[4].

Hepatitis B Treatment

In addition to its use in HIV, VIREAD has been evaluated for the treatment of chronic hepatitis B virus (HBV) infection. A Phase III clinical trial, Study 102, demonstrated that VIREAD is non-inferior to adefovir dipivoxil (Hepsera) in treating patients with HBeAg-negative chronic hepatitis B. The study showed that 70.8% of patients on VIREAD achieved a complete response compared to 48.8% on Hepsera[3].

Ongoing and Future Clinical Research

HIV Prevention and Treatment

Gilead continues to present new data on its antiviral portfolio, including VIREAD, at various scientific conferences. For instance, recent presentations at IDWeek 2024 highlighted the long-term efficacy and safety of Biktarvy, a combination regimen that includes tenofovir alafenamide (a prodrug of tenofovir), as a treatment option for people with HIV. These studies reinforce the role of VIREAD and its derivatives in HIV management[4].

Investigational Treatments

While VIREAD itself is not undergoing new Phase III trials, Gilead's pipeline includes several investigational treatments that build upon the success of tenofovir. For example, GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI), and an investigational once-weekly oral combination regimen of islatravir and lenacapavir, are being evaluated for their potential in HIV treatment[4].

Market Analysis

Global HIV Drugs Market

The global HIV drugs market, in which VIREAD is a significant player, is expected to grow from $30.52 billion in 2020 to $36.46 billion by 2025, at a compound annual growth rate (CAGR) of 3.9%. This growth is driven by the increasing demand for antiretroviral therapies and the stabilization of output by major pharmaceutical companies post-COVID-19 pandemic[2].

Market Segmentation

The HIV drugs market is segmented by type, application, and administration. VIREAD falls under the category of nucleoside reverse transcriptase inhibitors (NRTIs). The market is also segmented by distribution channels, including hospital pharmacies, retail pharmacies, and online pharmacies. VIREAD is predominantly distributed through hospital and retail pharmacies[2].

Projections and Revenue

Annual Revenue Projections

While VIREAD itself is not listed among the top 10 drugs by annual revenue in 2025, its inclusion in various combination therapies contributes significantly to the revenue of these regimens. For instance, Biktarvy, which contains tenofovir alafenamide, is a high-revenue generating drug within Gilead's portfolio[5].

Competitive Landscape

Gilead Sciences, the manufacturer of VIREAD, competes with other major players in the HIV drugs market, including ViiV Healthcare, Gilead Sciences, Merck & Co., Inc., Bristol-Myers Squibb Company, and Janssen (Johnson & Johnson). The competitive landscape is driven by innovation in antiviral therapies and the expansion of treatment options for HIV and other viral infections[2].

Safety and Tolerability

Adverse Events

Clinical trials have shown that VIREAD is generally well-tolerated. Common adverse events include abdominal pain, back pain, headache, and transaminase elevations. The incidence of these events is comparable to other antiviral drugs used in the treatment of HIV and hepatitis B[3].

Regulatory Status

VIREAD has received regulatory approvals in various regions, including the U.S. and Europe. It is approved as an anti-HIV medication and has been evaluated for its use in treating chronic hepatitis B, although it is not yet approved for this indication[3].

Key Takeaways

• Clinical Efficacy: VIREAD has demonstrated efficacy in treating HIV and has shown promise in clinical trials for chronic hepatitis B.
• Market Growth: The global HIV drugs market, in which VIREAD plays a significant role, is projected to grow to $36.46 billion by 2025.
• Combination Therapies: VIREAD is often used in combination with other antiretroviral drugs, contributing to the success of regimens like Biktarvy.
• Safety Profile: VIREAD has a generally well-tolerated safety profile, with common adverse events comparable to other antiviral drugs.
• Regulatory Approvals: VIREAD is approved for HIV treatment and is under evaluation for hepatitis B treatment.

FAQs

What is VIREAD used for?

VIREAD, or tenofovir disoproxil fumarate, is primarily used in the treatment of HIV infection. It is also being evaluated for its efficacy in treating chronic hepatitis B virus (HBV) infection.

What are the common side effects of VIREAD?

Common side effects of VIREAD include abdominal pain, back pain, headache, and transaminase elevations.

Is VIREAD approved for treating hepatitis B?

VIREAD is not yet approved for the treatment of chronic hepatitis B, although it has shown promising results in clinical trials.

How does VIREAD contribute to the global HIV drugs market?

VIREAD is a key component in various antiretroviral combination therapies, contributing significantly to the revenue and growth of the global HIV drugs market.

What are the future prospects for VIREAD in clinical research?

While VIREAD itself is not undergoing new Phase III trials, Gilead's pipeline includes several investigational treatments that build upon the success of tenofovir, ensuring continued innovation in HIV and other viral infection treatments.

Sources

1. Liver Disease News: "Phase 3 trials of treatment combo for hepatitis D expected in 2025"
2. Business Wire: "Global HIV Drugs Market Report 2021: Long-term Forecast to 2025, 2030"
3. Gilead Sciences: "Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus"
4. Gilead Sciences: "Gilead to Present Late Breaking Data Highlighting Antiviral Portfolio, Innovative Research Pipeline, and HIV Leadership at IDWeek 2024"
5. European Pharmaceutical Review: "Study reveals top 10 drugs by annual revenue in 2025"