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CLINICAL TRIALS PROFILE FOR STRIBILD

All Clinical Trials for STRIBILD

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00869557 ↗	Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2009-04-01	The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
NCT01095796 ↗	Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2010-03-01	To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.
NCT01106586 ↗	Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2010-04-01	To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.
NCT01475838 ↗	Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppr	Completed	Gilead Sciences	Phase 3	2011-11-01	This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
NCT01495702 ↗	Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed,	Completed	Gilead Sciences	Phase 3	2011-12-01	This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.
NCT01497899 ↗	Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2011-12-28	The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.
NCT01533259 ↗	Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed,	Completed	Gilead Sciences	Phase 3	2012-01-01	This study will evaluate the efficacy of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF)) single-tablet regimen (STR) after switching from a regimen consisting of raltegravir plus Truvada® (FTC/TDF) at baseline in maintaining HIV-1 RNA < 50 copies/mL at Week 12 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of Stribild over 24 and 48 weeks of treatment.

Clinical Trial Conditions for STRIBILD

Condition Name

Condition Name for STRIBILD
Intervention	Trials
HIV	13
HIV Infections	8
Acquired Immunodeficiency Syndrome	4
HIV Infection	2

Condition MeSH

Condition MeSH for STRIBILD
Intervention	Trials
HIV Infections	14
Acquired Immunodeficiency Syndrome	8
Immunologic Deficiency Syndromes	6
Infections	2

Clinical Trial Locations for STRIBILD

Trials by Country

Trials by Country for STRIBILD
Location	Trials
United States	155
Canada	15
Spain	8
United Kingdom	8
Puerto Rico	6

Trials by US State

Trials by US State for STRIBILD
Location	Trials
California	12
Florida	9
North Carolina	8
Massachusetts	8
District of Columbia	8

Clinical Trial Progress for STRIBILD

Clinical Trial Phase

Clinical Trial Phase for STRIBILD
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	7
Phase 2	2

Clinical Trial Status

Clinical Trial Status for STRIBILD
Clinical Trial Phase	Trials
Completed	22
Unknown status	4
Recruiting	1

Clinical Trial Sponsors for STRIBILD

Sponsor Name

Sponsor Name for STRIBILD
Sponsor	Trials
Gilead Sciences	18
University of Washington	1
Vancouver Infectious Diseases Centre	1

Sponsor Type

Sponsor Type for STRIBILD
Sponsor	Trials
Industry	22
Other	20

STRIBILD Market Analysis and Financial Projection

Stribild: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Stribild, a single-tablet regimen (STR) developed by Gilead Sciences, combines four active ingredients: elvitegravir, emtricitabine, tenofovir disoproxil fumarate, and cobicistat. This medication is designed to treat HIV-1 infection and has undergone extensive clinical trials to evaluate its efficacy and safety.

Clinical Trials Overview

Efficacy in Treatment-Naive Patients

Stribild was investigated in two major studies involving 1,422 adult patients with HIV-1 who had not received antiretroviral therapy before. In these studies, Stribild was compared to other HIV medications. The primary measure of effectiveness was the reduction in viral load to less than 50 HIV-1 RNA copies/ml after 48 weeks of treatment.

• In the first study, Stribild was compared to a combination of ritonavir, atazanavir, emtricitabine, and tenofovir disoproxil. Approximately 90% of patients treated with Stribild responded to treatment, compared to around 87% of patients on the comparator regimen[2].
• In the second study, Stribild was compared to a regimen containing efavirenz, emtricitabine, and tenofovir disoproxil. Here, about 88% of patients treated with Stribild responded to treatment, versus around 84% on the comparator regimen[2].

Efficacy in Adolescents

A third study focused on adolescents aged 12 to 18 who had not been previously treated for HIV-1. After 24 and 48 weeks, 88% of the 50 patients treated with Stribild showed a significant reduction in viral load[2].

Switching Studies

Studies GS-US-236-0115 and GS-US-236-0121 evaluated the efficacy, safety, and tolerability of switching to Stribild from other antiretroviral regimens. These studies showed that switching to Stribild maintained high rates of virologic suppression, with non-inferior results compared to staying on the baseline regimens. The switch was well tolerated, with infrequent discontinuations due to adverse events[3].

Safety and Tolerability

Common Side Effects

Stribild is generally well tolerated, but common side effects include nausea, diarrhea, headache, weakness, dizziness, difficulty sleeping, abnormal dreams, fatigue, and skin rash. More severe but rare side effects can include lactic acidosis and severe kidney problems that may also affect bones[2][3].

Drug Interactions

Stribild should not be used with certain medications due to potential drug interactions. These include alpha 1-adrenoreceptor antagonists, antiarrhythmics, ergot derivatives, gastrointestinal motility agents, statins, neuroleptics/antipsychotics, PDE-5 inhibitors for pulmonary arterial hypertension, sedatives/hypnotics, anticonvulsants, antimycobacterials, herbal products like St. John's wort, and blood thinners like dabigatran etexilate[1].

Market Analysis and Projections

Current Market Position

Stribild, along with other single-tablet regimens from Gilead Sciences, has been a significant player in the HIV treatment market. However, the market landscape is evolving, with newer treatments gaining traction.

Competition and Market Trends

Biktarvy, another STR from Gilead Sciences, has outpaced Stribild and other older STRs to become the market leader, with sales amounting to $4.6 billion in 2019. The HIV treatment market is expected to grow due to factors such as patients switching from older STRs, increasing HIV prevalence, and price rises in the US. However, this growth will be offset by generic erosion of major brands and the introduction of new therapies, including two-drug regimens from ViiV Healthcare[5].

Future Projections

• Market Growth: The HIV treatment market is projected to continue growing, driven by the uptake of newer therapies and the increasing prevalence of HIV.
• Competition: Biktarvy is expected to retain its position as the highest-selling HIV therapy, while ViiV Healthcare's two-drug regimens, such as Dovato and Juluca, will also contribute to market growth.
• New Therapies: New salvage therapies, including lenacapavir, are expected to play a significant role in the longer term[5].

Key Takeaways

• Efficacy: Stribild has demonstrated high efficacy in reducing viral load in both treatment-naive adults and adolescents.
• Safety: The medication is generally well tolerated, though it has specific side effects and drug interactions that need to be considered.
• Market Position: While Stribild remains a viable option, the market is shifting towards newer therapies like Biktarvy.
• Future Trends: The HIV treatment market will continue to evolve with new drug launches and changes in patient treatment preferences.

FAQs

What is Stribild and how does it work?

Stribild is a single-tablet regimen that combines elvitegravir, emtricitabine, tenofovir disoproxil fumarate, and cobicistat to treat HIV-1 infection. It works by inhibiting the replication of the HIV virus through different mechanisms, including integrase inhibition and reverse transcriptase inhibition.

What are the common side effects of Stribild?

Common side effects include nausea, diarrhea, headache, weakness, dizziness, difficulty sleeping, and skin rash. Rare but serious side effects can include lactic acidosis and severe kidney problems.

Can Stribild be used in children and adolescents?

Yes, Stribild is approved for use in children and adolescents aged 12 and over. Clinical trials have shown it to be effective in this age group.

What medications should not be used with Stribild?

Stribild should not be used with certain medications due to potential drug interactions, including alpha 1-adrenoreceptor antagonists, antiarrhythmics, ergot derivatives, and others.

How does Stribild compare to other HIV treatments in the market?

Stribild is one of several single-tablet regimens available, but it faces competition from newer treatments like Biktarvy, which has become the market leader. The choice of treatment depends on individual patient needs and tolerability.

What are the future projections for the HIV treatment market?

The market is expected to grow driven by the uptake of newer therapies, increasing HIV prevalence, and price rises. However, generic erosion and the introduction of new therapies will also impact the market dynamics.

Sources

1. Aidsmap: Stribild - Aidsmap
2. European Medicines Agency (EMA): Stribild | European Medicines Agency (EMA)
3. Health Products and Food Branch Inspectorate: Regulatory Decision Summary for STRIBILD
4. ClinicalTrials.gov: Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
5. Business Wire: World HIV Treatment Forecast and Market Analysis Report 2021-2027