CLINICAL TRIALS PROFILE FOR LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

All Clinical Trials for lamivudine; 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; tenofovir disoproxil fumarate

Condition Name

Condition Name for lamivudine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	20
HIV	10
HIV-1 Infection	7
Chronic Hepatitis B	4

Condition MeSH

Condition MeSH for lamivudine; tenofovir disoproxil fumarate
Intervention	Trials
HIV Infections	35
Hepatitis	20
Hepatitis B	19
Acquired Immunodeficiency Syndrome	16

Clinical Trial Locations for lamivudine; tenofovir disoproxil fumarate

Trials by Country

Trials by Country for lamivudine; 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; tenofovir disoproxil fumarate
Location	Trials
California	16
Illinois	14
Florida	14
New York	13
Colorado	12

Clinical Trial Progress for lamivudine; tenofovir disoproxil fumarate

Clinical Trial Phase

Clinical Trial Phase for lamivudine; 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; tenofovir disoproxil fumarate
Clinical Trial Phase	Trials
Completed	46
Recruiting	12
Unknown status	8

Clinical Trial Sponsors for lamivudine; tenofovir disoproxil fumarate

Sponsor Name

Sponsor Name for lamivudine; 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; tenofovir disoproxil fumarate
Sponsor	Trials
Other	104
Industry	47
NIH	16

Lamivudine; tenofovir disoproxil fumarate Market Analysis and Financial Projection

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

Introduction

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

Clinical Trials Update

DRIVE-AHEAD Trial

The DRIVE-AHEAD trial, a phase 3, multicenter, double-blind, noninferiority study, compared the efficacy and safety of Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) versus Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) in antiretroviral treatment-naive adults with HIV-1 RNA ≥1000 copies/mL. The results showed that DOR/3TC/TDF demonstrated noninferior efficacy to EFV/FTC/TDF at week 48 and week 96, with significantly fewer neuropsychiatric adverse events and minimal changes in lipid profiles[1][4].

PASO DOBLE Trial

While not directly focusing on Lamivudine and Tenofovir Disoproxil Fumarate, the PASO DOBLE trial is relevant as it compares different antiretroviral regimens. This trial investigated the 2-drug regimen Dovato (dolutegravir/lamivudine) versus the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) in people with HIV-1 who were virologically suppressed. The results indicated that the 2-drug regimen showed similar efficacy with less weight gain compared to the 3-drug regimen[3].

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, particularly among female patients, and efforts to achieve viral suppression[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 attributed to the presence of major pharmaceutical companies like Gilead Sciences Inc. in the US, which has seen significant sales increases in HIV and hepatitis B products[2].

End User Segments

The pregnant women segment holds a significant share in the Tenofovir Disoproxil Fumarate market, with a CAGR of 3.9% during the forecast period. Tenofovir Disoproxil Fumarate is recommended for pregnant women to prevent the transmission of HIV to their babies and to protect their own health. High antiretroviral therapy adherence among pregnant women, with 85% receiving treatment in 2020, further boosts this segment[2].

Market Drivers

Growing Number of Hepatitis B Patients

The increasing global cases of hepatitis B, with 296 million people living with chronic hepatitis B infection in 2019, drive the demand for Tenofovir Disoproxil Fumarate. This medication, as a nucleotide reverse transcriptase inhibitor, prevents the spread of hepatitis B and protects the liver from further infection[2].

Increase in Female HIV Patients

Women are more vulnerable to HIV infection, and the growing number of female HIV patients increases the demand for antiretroviral therapies, including those containing Tenofovir Disoproxil Fumarate. In 2020, 1.5 million people acquired HIV, with a significant proportion being women, which further drives the market growth[2].

Market Restraints

Side Effects

Despite its efficacy, Tenofovir Disoproxil Fumarate is associated with side effects such as nausea, rash, diarrhea, headache, pain, and depression. These side effects can restrict its usage in the medical sector, acting as a restraint on market growth[2].

Future Projections

Market Forecast

The global Tenofovir Disoproxil Fumarate market is expected to continue growing, driven by the increasing prevalence of HIV and hepatitis B. The market is forecasted to expand with a CAGR of 4.5% from 2022 to 2027, with North America remaining a key growth region[2].

Combination Drugs

The market for combination drugs, including those with Lamivudine and Tenofovir Disoproxil Fumarate, is expected to grow as these regimens offer convenience and improved adherence. The trend towards two-drug regimens, as seen in the PASO DOBLE trial, may also influence future market dynamics[3][5].

Key Takeaways

• Clinical Efficacy: Lamivudine and Tenofovir Disoproxil Fumarate have demonstrated noninferior efficacy in clinical trials compared to other antiretroviral regimens.
• Market Growth: The market for Tenofovir Disoproxil Fumarate is projected to grow at a CAGR of 4.5% from 2022 to 2027.
• Regional Focus: North America is the fastest-growing region, driven by major pharmaceutical companies.
• End User Segments: Pregnant women and female HIV patients are significant segments driving market growth.
• Market Drivers: Increasing cases of hepatitis B and HIV, particularly among women, are key drivers.
• Market Restraints: Side effects associated with Tenofovir Disoproxil Fumarate can restrict its usage.

FAQs

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

Lamivudine and Tenofovir Disoproxil Fumarate are primarily used to treat HIV and chronic hepatitis B, acting as nucleotide reverse transcriptase inhibitors to prevent the viruses from multiplying in the body.

What are the key findings from the DRIVE-AHEAD trial?

The DRIVE-AHEAD trial showed that Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate demonstrated noninferior efficacy to Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate with fewer neuropsychiatric adverse events and minimal changes in lipid profiles.

How is the Tenofovir Disoproxil Fumarate market expected to grow?

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

What are the major side effects associated with Tenofovir Disoproxil Fumarate?

The major side effects include nausea, rash, diarrhea, headache, pain, and depression, which can restrict its usage in the medical sector.

Which region is the fastest-growing in the Tenofovir Disoproxil Fumarate market?

North America is the fastest-growing region, with a CAGR of 5.2% during the forecast period, driven by the presence of major pharmaceutical companies like Gilead Sciences Inc.

Sources

1. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz (EFV)/Emtricitabine (FTC)/TDF in Treatment-Naive Adults With HIV-1 Infection: Week 96 Results From the DRIVE-AHEAD Study. PubMed.
2. Tenofovir Disoproxil Fumarate Market Size Report, 2022-2027. IndustryARC.
3. ViiV Healthcare announces positive data demonstrating 2-drug regimen Dovato is non-inferior to 3-drug regimen Biktarvy in people living with HIV. ViiV Healthcare.
4. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (TDF) Versus Efavirenz (EFV)/Emtricitabine (FTC)/TDF in Treatment-Naive Adults With HIV-1 Infection: Week 96 Results From the DRIVE-AHEAD Study. Oxford Academic.
5. Tenofovir Disoproxil Fumarate and Its Combination Drugs Market Report. Cognitive Market Research.