Injectable HIV Treatment for Women

Overseen By Jaimie P Meyer, MD, MS, FACP

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Oral ART

Disqualifiers: Pregnant, Breast-feeding, CAB/RPV resistance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 months

50 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, since participants must be on oral ART (antiretroviral therapy) and virally suppressed, it seems likely you will continue your current HIV treatment until switching to the injectable form.

What data supports the effectiveness of the drug Cabotegravir/Rilpivirine for treating HIV in women?

Research shows that the injectable drug Cabotegravir/Rilpivirine is as effective as some oral HIV treatments, with many patients finding the monthly or bi-monthly injections acceptable. It has been successful in achieving viral suppression, especially in people who have trouble sticking to daily oral medication. ^{1 2 3 4 5}

Is the injectable HIV treatment Cabotegravir/Rilpivirine safe for women?

Cabotegravir and rilpivirine injections have been shown to be generally safe in clinical trials, with most people experiencing only mild reactions at the injection site. However, there is limited data on its safety during pregnancy and breastfeeding, so women who are pregnant or breastfeeding should consult their doctor. ^{1 2 3 5 6}

How is the drug Cabotegravir/Rilpivirine unique for treating HIV?

Cabotegravir/Rilpivirine is unique because it is the first long-acting injectable treatment for HIV, requiring only monthly or bi-monthly injections instead of daily pills, which can help people who have trouble sticking to a daily medication routine. ^{1 2 3 7 8}

What is the purpose of this trial?

This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

Research Team

Jaimie Meyer, MD, MS, FACP

Principal Investigator

Yale University

Eligibility Criteria

This trial is for women living with HIV who have health-related social needs. It's designed to see how well they do when a pharmacist helps manage their treatment, which includes long-acting injectable drugs. The study will also use telehealth to reach participants.

Inclusion Criteria

Receiving HIV care-related services from Yale New Haven Health (YNHH)

Living with diagnosed HIV

Have experienced at least one HRSN: a) homelessness or housing insecurity; b) food insecurity; c) criminal legal system involvement; OR d) substance use in the past 6 months (from self-report at screening)

Exclusion Criteria

I am able to understand and willing to sign the informed consent myself.

I cannot take CAB/RPV LA due to health reasons.

Pregnant or breast-feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Introductory Telehealth Visit

Participants meet with a clinic-based pharmacist via telehealth to discuss CAB/RPV LA and possible switch from oral to injectable therapy

1 visit

1 telehealth visit (phone or video)

Treatment

Participants receive CAB/RPV LA injections and engage with the CDTM+ intervention

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cabotegravir/Rilpivirine

Trial Overview The intervention being tested is a pharmacist-led model where the medication management for HIV treatment involves long-acting injections of Cabotegravir/Rilpivirine. This approach will be assessed for its effectiveness and implementation through both in-person and telehealth services.

Participant Groups

Group I: Pharmacist lead CDTM+ Experimental Treatment 2 Interventions

Participants will meet with a clinic-based pharmacist via telehealth for an introductory visit to discuss CAB/RPV LA and possible switch from oral to injectable therapy. The tele-visit can occur by phone or video visit.

Cabotegravir/Rilpivirine is already approved in United States, European Union for the following indications:

Approved in United States as Cabenuva for:

• Human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure

Approved in European Union as Vocabria and Rekambys for:

• Maintenance treatment of adults who have undetectable HIV levels in the blood (viral load less than 50 copies/mL) with their current antiretroviral treatment, and when the virus has not developed resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

ViiV Healthcare

Industry Sponsor

Trials

379

Recruited

479,000+

Founded

2009

Headquarters

London, England, UK

Known For

HIV Research

Top Products

- Tivicay (dolutegravir), - Triumeq (abacavir/dolutegravir/lamivudine), - Juluca (dolutegravir/rilpivirine), - Apretude (cabotegravir)

Dr. Harmony Garges

ViiV Healthcare

Chief Medical Officer

MD

Deborah Waterhouse

ViiV Healthcare

Chief Executive Officer since 2017

Bachelor's degree in Business Administration

Findings from Research

Cabotegravir and rilpivirine, as long-acting injectable therapy for HIV-1, have shown to be non-inferior to traditional oral triple-therapy in phase II and III trials, indicating their effectiveness as a treatment option.

Patients generally accept the 4-weekly or 8-weekly injections despite some experiencing injection-site reactions, but there are still important questions regarding missed doses, drug interactions, and the therapy's efficacy across different HIV-1 subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating cabotegravir/rilpivirine long-acting, injectable in the treatment of HIV infection: emerging data and therapeutic potential. Fernandez, C., van Halsema, CL.[2020]

Cabenuva is the first complete injectable therapy for adults with HIV-1, combining cabotegravir and rilpivirine, and is administered once a month after an initial month of oral treatment.

This innovative treatment offers a new option for HIV management, potentially improving adherence and convenience for patients compared to daily oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Extended-Release Injectable Drug Therapy for HIV. Aschenbrenner, DS.[2023]

Cabotegravir (CAB) combined with rilpivirine (RPV) is the first long-acting dual therapy approved for HIV-1 treatment, showing comparable maintenance of viral suppression over 160 weeks with low rates of virological failure.

This regimen offers a convenient alternative to daily oral therapy, as it is administered via intramuscular injections every 4 weeks, with minimal adverse effects and no negative impact on renal or bone health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. Durham, SH., Chahine, EB.[2022]

Long-acting injectable cabotegravir-rilpivirine (CAB-RPV) significantly improves viral suppression rates in people with HIV who have adherence challenges, achieving 60% suppression at 3 months compared to only 13% with standard oral treatment.

In a model projecting outcomes over 3 years, CAB-RPV combined with supportive services is expected to lead to a 44% viral suppression rate and a life expectancy of 9.4 years, outperforming both standard oral treatments and those with additional support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Projected Benefits of Long-Acting Antiretroviral Therapy in Nonsuppressed People With Human Immunodeficiency Virus Experiencing Adherence Barriers. Chen, W., Gandhi, M., Sax, PE., et al.[2023]

In a study of 1,752 HIV-positive patients, 31.2% were found ineligible for the injectable treatment of cabotegravir and rilpivirine due to factors like detectable viral load and history of virological failures.

The proportion of ineligible patients increased to 47.3% when considering those with complete resistance test data, highlighting significant barriers to the feasibility of this treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are we ready for long-acting? A feasibility evaluation of long-acting cabotegravir-rilpivirine in clinical practice. Borghetti, A., Farinacci, D., Ciccullo, A., et al.[2022]

Cabotegravir/rilpivirine (CAB/RPV) is the first complete injectable antiretroviral therapy approved for HIV treatment, offering a monthly intramuscular injection option that improves adherence compared to daily oral medications.

Clinical trials have shown CAB/RPV to achieve high rates of sustained viral suppression with a favorable safety profile, while also enhancing patient satisfaction due to its convenience and confidentiality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. Howe, ZW., Norman, S., Lueken, AF., et al.[2022]

Cabenuva (cabotegravir/rilpivirine) is a long-acting injectable treatment for HIV that has shown equal effectiveness to traditional oral antiretroviral therapy in maintaining HIV-1 suppression, based on major clinical trials like ATLAS and FLAIR.

The ATLAS-2 M study demonstrated that administering Cabenuva every 8 weeks is just as effective as every 4 weeks, which can improve patient adherence and reduce the stigma associated with frequent treatment, while also minimizing risks of treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV. Taki, E., Soleimani, F., Asadi, A., et al.[2022]

Long-acting injectable therapies, cabotegravir (CAB) and rilpivirine (RPV), have been shown to be as effective as traditional oral antiretroviral therapy (ART) for HIV-1, maintaining efficacy over 96 weeks in clinical trials with virologically suppressed adults.

CAB has also demonstrated effectiveness as a preexposure prophylaxis (PrEP) option, significantly reducing HIV infections compared to daily oral medication, indicating its potential for broader use in HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. Bares, SH., Scarsi, KK.[2023]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating cabotegravir/rilpivirine long-acting, injectable in the treatment of HIV infection: emerging data and therapeutic potential. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

First Extended-Release Injectable Drug Therapy for HIV. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cabotegravir-Rilpivirine: The First Complete Long-Acting Injectable Regimen for the Treatment of HIV-1 Infection. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Projected Benefits of Long-Acting Antiretroviral Therapy in Nonsuppressed People With Human Immunodeficiency Virus Experiencing Adherence Barriers. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Are we ready for long-acting? A feasibility evaluation of long-acting cabotegravir-rilpivirine in clinical practice. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Therapeutic review of cabotegravir/rilpivirine long-acting antiretroviral injectable and implementation considerations at an HIV specialty clinic. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A new paradigm for antiretroviral delivery: long-acting cabotegravir and rilpivirine for the treatment and prevention of HIV. [2023]