CLINICAL TRIALS PROFILE FOR LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00013520 ↗	Comparison of Three Different Initial Treatments Without Protease Inhibitors for HIV Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to compare the effectiveness, safety, and tolerability of 3 anti-HIV combination treatments that do not use protease inhibitors (PIs). The current rule for starting treatment of HIV infection is to combine members from different classes of anti-HIV drugs, such as 2 nucleoside reverse transcriptase inhibitors (NRTIs) and either a PI or a nonnucleoside reverse transcriptase inhibitor (NNRTI). However, these combinations can be complicated and difficult to take, can cause a number of side effects, and may become ineffective. Combinations that are simpler, better tolerated, and more effective are needed. Because PIs can cause long-term side effects and because HIV can become resistant to many of them at the same time, anti-HIV combination treatments that do not use PIs are being tested.
NCT00033163 ↗	A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Control of hepatitis B virus (HBV) infection can be difficult in HIV infected people who have taken the antiviral lamivudine (3TC). These people may have HBV that has become resistant to 3TC. Adefovir dipivoxil (ADV) has shown promising anti-HBV activity in clinical trials; tenofovir disoproxil fumarate (TDF) is used to treat HIV and may also be effective against HBV. The purpose of this study is to find out if adding ADV or TDF to a highly active antiretroviral therapy (HAART) regimen that includes 3TC has an effect on HBV infection in patients coinfected with HIV and HBV. The tolerability and safety of these drugs will be examined.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.
NCT00039741 ↗	Anti-HIV Drug Regimens and Treatment-Switching Guidelines in HIV Infected Children	Completed	PENTA Foundation	Phase 2/Phase 3	2002-08-01	Little is known about what treatment combinations are best for HIV infected children. This study examined the long-term effectiveness of different anti-HIV drug combinations in children and strategies for switching treatment if the first treatment does not work. The study enrolled children who had not previously taken anti-HIV medication. Participants in this study were recruited in the United States, South America and Europe. Some European children may also enroll in a substudy that will observe changes in body fat in children taking anti-HIV medications.

Clinical Trial Conditions for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Condition Name

Condition Name for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	20
HIV	10
HIV-1 Infection	7
Chronic Hepatitis B	4

Condition MeSH

Condition MeSH for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Intervention	Trials
HIV Infections	35
Hepatitis	20
Hepatitis B	19
Acquired Immunodeficiency Syndrome	16

Clinical Trial Locations for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Trials by Country

Trials by Country for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
United States	243
China	27
Germany	27
Canada	20
Italy	20

Trials by US State

Trials by US State for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Location	Trials
California	16
Illinois	14
Florida	14
New York	13
Colorado	12

Clinical Trial Progress for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
Phase 4	28
Phase 3	24
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Clinical Trial Phase	Trials
Completed	46
Recruiting	12
Unknown status	8

Clinical Trial Sponsors for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

Sponsor Name

Sponsor Name for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Gilead Sciences	18
National Institute of Allergy and Infectious Diseases (NIAID)	14
Merck Sharp & Dohme Corp.	6

Sponsor Type

Sponsor Type for LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Sponsor	Trials
Other	104
Industry	47
NIH	16

LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Lamivudine and Tenofovir Disoproxil Fumarate

Introduction

Lamivudine and Tenofovir Disoproxil Fumarate are crucial components in the treatment and prevention of HIV/AIDS and chronic hepatitis B. This article delves into recent clinical trials, market analysis, and future projections for these medications.

Clinical Trials Update

Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF)

A recent prospective, open-label, single-arm trial evaluated the safety, tolerability, and adherence of the single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) for nonoccupational HIV postexposure prophylaxis (PEP). The trial included individuals with potential HIV-1 exposure within 72 hours and followed them up at day 7, week 4, and week 12. The primary endpoint was noncompletion of PEP at day 28, with secondary endpoints including adverse effects, adherence, and rate of seroconversion. This regimen demonstrated good safety, tolerability, and adherence profiles[1].

Doravirine/Islatravir (DOR/ISL)

Merck has announced topline results from two pivotal Phase 3 trials evaluating the once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for adults with virologically suppressed HIV-1 infection. These trials, MK-8591A-051 and MK-8591A-052, showed that DOR/ISL was non-inferior to comparator antiretroviral therapies. The trials met primary efficacy and safety objectives, although the superiority criteria were not met in one of the trials. This regimen, which includes lamivudine and tenofovir disoproxil fumarate in other combinations, highlights the ongoing development of more convenient and effective antiretroviral therapies[3][4].

Market Analysis

Market Size and Growth

The Tenofovir Disoproxil Fumarate market is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4.5% from 2022 to 2027. This growth is driven by increasing cases of hepatitis B and HIV/AIDS, as well as efforts by countries to achieve viral suppression against HIV. The market is also influenced by the availability of generic versions of tenofovir disoproxil fumarate, which has expanded access to treatment[2].

Regional Market

North America is the fastest-growing region in the Tenofovir Disoproxil Fumarate market, with a CAGR of 5.2% during the forecast period. This growth is largely due to the presence of major pharmaceutical companies like Gilead Sciences Inc., which is a leading producer of tenofovir disoproxil fumarate. The increase in HIV and hepatitis B cases in the US has significantly boosted the sales of these drugs[2].

Market Drivers

• Growing Number of Hepatitis B Patients: The increasing global cases of hepatitis B have positively impacted the demand for tenofovir disoproxil fumarate. According to the World Health Organization, 296 million people were living with chronic hepatitis B infection in 2019, resulting in an estimated 820,000 deaths[2].
• Increase in Female HIV Patients: Women are more vulnerable to HIV infection, and the growing number of female HIV patients has driven the demand for antiretroviral therapies, including those containing lamivudine and tenofovir disoproxil fumarate[2].

Market Projections

Forecast Period

The global Tenofovir Disoproxil Fumarate market is expected to continue its growth trajectory from 2025 to 2031. The market size and revenue are projected to increase, driven by the rising prevalence of HIV and hepatitis B, as well as the expanding use of combination therapies that include lamivudine and tenofovir disoproxil fumarate[5].

Segment Analysis

The market has been segmented by type, application, and region. The hospital segment accounted for a significant share of the global market in 2023 and is expected to continue growing. The analysis also highlights that different dosages of tenofovir disoproxil fumarate tablets, such as 150mg, 200mg, 250mg, and 300mg, will cater to various patient needs based on age and condition[5].

Challenges and Opportunities

While the market is driven by increasing demand, it also faces challenges such as side effects associated with tenofovir disoproxil fumarate, including nausea, rash, diarrhea, headache, pain, and depression. However, the development of new combination therapies and the expansion of generic options are expected to mitigate these challenges and provide more treatment options for patients[2].

Safety and Adherence Considerations

Adverse Events

Clinical trials have shown that regimens including lamivudine and tenofovir disoproxil fumarate generally have a favorable safety profile. However, adverse events such as neuropsychiatric symptoms, sleep disorders, and changes in lipid profiles have been reported. For instance, the DELSTRIGO regimen (doravirine, lamivudine, and tenofovir disoproxil fumarate) showed lower rates of neuropsychiatric adverse events compared to other antiretroviral therapies[4].

Coinfection with HBV

Patients coinfected with HIV-1 and HBV need careful monitoring when initiating or discontinuing antiretroviral therapy, especially those containing lamivudine or tenofovir disoproxil fumarate. Severe acute exacerbations of HBV have been reported in such cases, emphasizing the need for clinical and laboratory follow-up[4].

Key Takeaways

• Clinical Trials: Recent trials have demonstrated the safety, tolerability, and efficacy of regimens including lamivudine and tenofovir disoproxil fumarate for HIV and hepatitis B treatment.
• Market Growth: The market is projected to grow at a CAGR of around 4.5% from 2022 to 2027, driven by increasing cases of HIV and hepatitis B.
• Regional Focus: North America is the fastest-growing region, with significant contributions from major pharmaceutical companies.
• Safety and Adherence: While these regimens have a favorable safety profile, they require careful monitoring, especially in patients coinfected with HBV.

FAQs

What is the primary use of Lamivudine and Tenofovir Disoproxil Fumarate?

Lamivudine and Tenofovir Disoproxil Fumarate are primarily used in the treatment and prevention of HIV/AIDS and chronic hepatitis B.

What are the recent clinical trial findings for these medications?

Recent clinical trials have shown that regimens including these medications are safe, tolerable, and effective for HIV postexposure prophylaxis and treatment of virologically suppressed HIV-1 infection.

What is the projected market growth for Tenofovir Disoproxil Fumarate?

The market is projected to grow at a CAGR of around 4.5% from 2022 to 2027, driven by increasing cases of HIV and hepatitis B.

Which region is leading the growth in the Tenofovir Disoproxil Fumarate market?

North America is the fastest-growing region, with a CAGR of 5.2% during the forecast period, largely due to the presence of major pharmaceutical companies.

What are the potential side effects of Tenofovir Disoproxil Fumarate?

Potential side effects include nausea, rash, diarrhea, headache, pain, and depression, as well as neuropsychiatric symptoms in some cases.

Sources

1. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV Postexposure Prophylaxis - Academic.oup.com
2. Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027 - Industryarc.com
3. Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational Once-Daily Oral Two-Drug Single-Tablet Regimen of Doravirine/Islatravir - Businesswire.com
4. Merck Announces Topline Results from Pivotal Phase 3 Trials Evaluating Investigational Once-Daily Oral Two-Drug Single-Tablet Regimen of Doravirine/Islatravir - Merck.com
5. Tenofovir Disoproxil Fumarate and Its Combination Drugs Market Report - Cognitivemarketresearch.com