CLINICAL TRIALS PROFILE FOR CABOTEGRAVIR; RILPIVIRINE

All Clinical Trials for Cabotegravir; Rilpivirine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02799264 ↗	A Study to Evaluate the Effect of High Fat Meal on Cabotegravir	Completed	Glaxosmithkline/Quintiles	Phase 1	2016-06-01	Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase 3 treatment studies is with food regardless of fat or calorie content, when administered along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover study in healthy adult subjects to assess the effect of a high fat meal on the single dose pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12 subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule 'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to 'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects will be followed up to 30 days from the day of receiving first dose of cabotegravir to evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.
NCT02799264 ↗	A Study to Evaluate the Effect of High Fat Meal on Cabotegravir	Completed	ViiV Healthcare	Phase 1	2016-06-01	Cabotegravir is being developed for the treatment of human immunodeficiency virus (HIV) 1 infection. Specifically, it is being developed as a component of a 2-drug maintenance regimen (post-induction of viral suppression) that includes rilpivirine. Rilpivirine requires food for optimal absorption; therefore the recommended intake of cabotegravir in the planned Phase 3 treatment studies is with food regardless of fat or calorie content, when administered along with rilpivirine. This is a single-center, randomized, open-label, two-way crossover study in healthy adult subjects to assess the effect of a high fat meal on the single dose pharmacokinetics of CAB 30 mg. Approximately, 24 subjects will be enrolled in the study and will be screened for 30 days. Twelve subjects with at least 10 hours of fasting will be randomized to receive a single dose of cabotegravir orally (Schedule 'A'). The remaining 12 subjects will receive a single dose of cabotegravir orally along with high fat meal (Schedule 'B'). After 15 days, the subjects earlier undergoing 'Schedule A' will be switched to 'Schedule B' and those undergoing 'Schedule B' will undergo 'Schedule A'. All the subjects will be followed up to 30 days from the day of receiving first dose of cabotegravir to evaluate the effect of a high fat meal on the pharmacokinetics of cabotegravir.
NCT02938520 ↗	Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants	Active, not recruiting	GlaxoSmithKline	Phase 3	2016-10-27	The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.
NCT02938520 ↗	Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants	Active, not recruiting	Janssen Pharmaceuticals	Phase 3	2016-10-27	The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.
NCT02938520 ↗	Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants	Active, not recruiting	ViiV Healthcare	Phase 3	2016-10-27	The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week [-20] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) <50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA <50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.
NCT02951052 ↗	Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults	Active, not recruiting	GlaxoSmithKline	Phase 3	2016-10-28	The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were randomized to continue their current ART regimen will be given an option to switch to CAB LA + RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at Week 56.

Clinical Trial Conditions for Cabotegravir; Rilpivirine

Condition Name

Condition Name for Cabotegravir; Rilpivirine
Intervention	Trials
HIV Infections	14
HIV-1-infection	6
Infection, Human Immunodeficiency Virus	4
Human Immunodeficiency Virus Type 1 (HIV-1)	2

Condition MeSH

Condition MeSH for Cabotegravir; Rilpivirine
Intervention	Trials
HIV Infections	16
Acquired Immunodeficiency Syndrome	8
Immunologic Deficiency Syndromes	6
Infections	4

Clinical Trial Locations for Cabotegravir; Rilpivirine

Trials by Country

Trials by Country for Cabotegravir; Rilpivirine
Location	Trials
United States	143
Germany	23
Canada	22
South Africa	19
Spain	10

Trials by US State

Trials by US State for Cabotegravir; Rilpivirine
Location	Trials
Georgia	12
California	11
Florida	10
Texas	9
New York	8

Clinical Trial Progress for Cabotegravir; Rilpivirine

Clinical Trial Phase

Clinical Trial Phase for Cabotegravir; Rilpivirine
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	12
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Cabotegravir; Rilpivirine
Clinical Trial Phase	Trials
Active, not recruiting	9
Not yet recruiting	7
Recruiting	4

Clinical Trial Sponsors for Cabotegravir; Rilpivirine

Sponsor Name

Sponsor Name for Cabotegravir; Rilpivirine
Sponsor	Trials
ViiV Healthcare	15
Janssen Pharmaceuticals	6
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for Cabotegravir; Rilpivirine
Sponsor	Trials
Industry	29
Other	19
NIH	7

Clinical Trials Update, Market Analysis, and Projections for Cabotegravir and Rilpivirine

Last updated: July 16, 2025

Introduction

Cabotegravir and rilpivirine stand at the forefront of HIV treatment innovation, offering long-acting injectable options that address adherence challenges in antiretroviral therapy. Cabotegravir, an integrase strand transfer inhibitor, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor, form a powerful duo in regimens like Cabenuva, approved by the FDA in 2021. As global HIV cases persist and treatment demands evolve, these drugs are reshaping the market. This article examines the latest clinical trial updates, current market dynamics, and future projections, equipping business professionals with actionable insights.

Clinical Trials Update

Recent clinical trials for cabotegravir and rilpivirine highlight their efficacy in HIV prevention and treatment, with a focus on long-acting formulations that reduce dosing frequency. In the ATLAS-2M study, completed in 2022, cabotegravir combined with rilpivirine demonstrated sustained viral suppression in over 1,000 participants over 96 weeks. This Phase 3 trial, conducted by ViiV Healthcare, reported a 1.7% virologic failure rate, underscoring the regimen's reliability for patients with suppressed viral loads. Participants received bimonthly injections, achieving comparable outcomes to daily oral therapies, which could transform adherence rates in resource-limited settings.

For cabotegravir alone, the HPTN 083 trial, finalized in 2021, emphasized its role in pre-exposure prophylaxis (PrEP). This study involved 4,500 at-risk individuals and showed a 66% reduction in HIV acquisition compared to daily tenofovir disoproxil fumarate/emtricitabine. ViiV Healthcare's ongoing Phase 3b trial, expected to conclude in 2024, is exploring cabotegravir's use in diverse populations, including adolescents, potentially expanding its indications.

Rilpivirine's trials have focused on combination safety and real-world applicability. The Phase 3b STPI-RIS study, published in 2023, evaluated rilpivirine with cabotegravir in patients switching from oral regimens. Results indicated high satisfaction rates, with 95% of participants preferring the injectable over daily pills due to improved quality of life. However, challenges emerged, including injection-site reactions in 10-15% of cases, which researchers are addressing in follow-up studies.

Emerging data from the FLAIR trial extension, reported in early 2024, reinforces rilpivirine's long-term tolerability. This trial, involving 600 participants, showed no significant resistance development after two years, a critical factor for sustaining market viability. Trials in low- and middle-income countries, such as those under the WHO's global access programs, are underway, with interim results suggesting equitable efficacy across demographics.

These updates signal a shift toward personalized HIV management, where cabotegravir and rilpivirine could reduce the burden of daily medication. Stakeholders should monitor these trials for regulatory impacts, as approvals in new regions like Asia-Pacific could accelerate adoption.

Market Analysis

The market for cabotegravir and rilpivirine has expanded rapidly, driven by demand for long-acting therapies amid a global HIV market valued at $28 billion in 2023. ViiV Healthcare, a subsidiary of GlaxoSmithKline and Pfizer, dominates with Cabenuva, capturing an 8% share of the HIV treatment segment. In 2023, sales reached $1.2 billion, propelled by uptake in the U.S. and Europe, where reimbursement policies favor innovative injectables.

Competition intensifies from Gilead Sciences' Biktarvy, which holds a 25% market share through its oral daily regimen. However, cabotegravir-rilpivirine differentiates itself with adherence advantages, appealing to patients with lifestyle constraints. Pricing remains a barrier: Cabenuva costs around $22,000 annually in the U.S., compared to $14,000 for generic oral alternatives, influencing market penetration in emerging economies.

Geographically, North America accounts for 45% of revenue, fueled by high diagnosis rates and insurance coverage. In contrast, sub-Saharan Africa, with 25 million HIV cases, sees limited access due to supply chain issues and patent restrictions. Generic manufacturers like Mylan are challenging these dynamics, with biosimilar filings anticipated by 2025, potentially eroding ViiV's margins.

Market trends reveal a 15% annual growth in long-acting injectables, as healthcare providers prioritize patient-centric solutions. Regulatory approvals, such as the European Medicines Agency's 2022 nod for cabotegravir PrEP, have bolstered market confidence, with partnerships like ViiV's collaboration with the Gates Foundation enhancing global distribution.

Market Projections

Looking ahead, the cabotegravir-rilpivirine market is poised for double-digit growth, projecting to reach $3.5 billion by 2028, according to IQVIA forecasts. This expansion hinges on trial outcomes and broader approvals, with cabotegravir's PrEP applications driving a 20% compound annual growth rate in prevention-focused sales.

By 2025, expect cabotegravir to capture 15% of the PrEP market, as ongoing trials validate its use in high-risk groups. Rilpivirine's role in combination therapies will grow, particularly in regions adopting WHO guidelines for long-acting options. However, patent expirations loom: Cabotegravir's key patents end in 2030, inviting generic competition that could halve prices and expand access in developing markets.

Economic factors, including inflation and healthcare budgets, will shape projections. In the U.S., Biden administration initiatives for HIV elimination could add $500 million in annual revenue through subsidized programs. Globally, partnerships with UNITAID may reduce costs by 30% in low-income countries, fostering a 25% market share increase in these areas by 2027.

Risks include supply disruptions and emerging HIV variants, but innovations like once-yearly formulations in ViiV's pipeline could mitigate these. Investors should target growth in Asia, where trials are ramping up, potentially adding $1 billion in revenue by 2029.

Conclusion

Cabotegravir and rilpivirine are redefining HIV care through proven clinical efficacy and strategic market positioning. As trials advance and approvals expand, these drugs offer a pathway to improved patient outcomes and market stability.

Key Takeaways

• Cabotegravir-rilpivirine combinations achieve high viral suppression rates, with ATLAS-2M showing 98.3% efficacy over 96 weeks.
• The market grew to $1.2 billion in 2023, with projections hitting $3.5 billion by 2028, driven by long-acting therapy demand.
• Patent expirations by 2030 could introduce generics, potentially reducing prices and increasing accessibility in emerging markets.
• Ongoing trials in diverse populations may lead to new approvals, boosting revenue in Asia-Pacific and Africa.
• Competition from oral regimens like Biktarvy pressures pricing, but adherence benefits maintain a competitive edge.

Frequently Asked Questions (FAQs)

1. What recent advancements have improved cabotegravir's effectiveness in HIV prevention? Recent Phase 3 trials like HPTN 083 have demonstrated a 66% reduction in HIV acquisition rates compared to standard oral PrEP, highlighting its potential as a leading preventive option.
2. How does rilpivirine compare to other HIV drugs in terms of side effects? Rilpivirine shows lower rates of metabolic side effects than some NNRTIs, but injection-site reactions occur in 10-15% of users, as noted in the STPI-RIS study.
3. What factors could influence the future market share of cabotegravir-rilpivirine? Factors include trial outcomes, patent expirations, and regional approvals, with IQVIA predicting a 20% growth in PrEP-related sales by 2025.
4. Are there any upcoming trials that could expand these drugs' applications? Yes, ViiV's Phase 3b trial for adolescents is set to conclude in 2024, potentially broadening indications to younger demographics.
5. How might generic entry affect pricing for these drugs? Generic competition post-2030 could lower prices by up to 50%, making treatments more accessible in low-income regions, according to market analyses from IQVIA.

Sources Cited

1. ClinicalTrials.gov. ATLAS-2M Study: A Phase 3b, Randomized, Open-Label Study. Available at: https://clinicaltrials.gov/study/NCT03299049.
2. ViiV Healthcare. HPTN 083 Trial Results. Published 2021. Available at: https://www.viivhealthcare.com/en-gb/media-centre/press-releases/2021/july/hptn-083-confirms-cabotegravir/.
3. IQVIA Institute. Global HIV Market Forecast Report. Published 2023. Available at: https://www.iqvia.com/institute/reports/hiv-market-forecast.
4. European Medicines Agency. Approval Summary for Cabotegravir. Published 2022. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/cabotegravir.