What side effects are associated with this type of intervention?

Common treatments for HIV, such as those involving integrase strand transfer inhibitors (INSTIs) like Bictegravir and Dolutegravir, often include side effects such as diarrhea and nausea. These treatments, when combined with emtricitabine and tenofovir alafenamide, are generally well-tolerated with no treatment-related serious adverse events or deaths reported. Capsid inhibitors like Lenacapavir are newer and less widely studied, but they are expected to have a similar safety profile. Overall, these regimens are effective and have manageable side effects, making them suitable for long-term use in managing HIV.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of HIV, particularly focusing on integrase strand transfer inhibitors (INSTIs) and other combination therapies. Bictegravir, an INSTI, is part of a fixed-dose combination with emtricitabine and tenofovir alafenamide, which has shown efficacy in clinical trials. Another INSTI, dolutegravir, is also commonly used in combination regimens. These treatments are designed to inhibit the integration of viral DNA into the host genome, a critical step in HIV replication. While Lenacapavir, a capsid inhibitor, is still under study, it represents a novel approach by targeting the HIV capsid, which is essential for viral assembly and disassembly. These advancements reflect ongoing efforts to improve HIV treatment efficacy and patient outcomes.

What other types of research exist?

Promising novel alternatives to Bictegravir and Lenacapavir for HIV treatment in 2024 include Islatravir, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), and Lenacapavir, a long-acting capsid inhibitor. Additionally, Doravirine, a novel non-nucleoside reverse transcriptase inhibitor (NNRTI), and Cabotegravir, a long-acting integrase strand transfer inhibitor (INSTI), are also noteworthy. These agents offer new mechanisms of action and potential benefits in terms of dosing convenience and resistance profiles.

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Integrase Strand Transfer Inhibitor

Bictegravir + Lenacapavir for HIV (ARTISTRY-1 Trial)

Phase 2 & 3

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two HIV medications, bictegravir and lenacapavir, either separately or combined into one pill. It aims to see if these new treatments work better than current therapies for people living with HIV. These drugs help control HIV by stopping the virus from making more copies of itself. Bictegravir is a newly approved medication combined with other drugs, while lenacapavir is a long-acting medication recently approved in the EU.

Who is the study for?

This trial is for people with HIV-1 who have been successfully treated but are on complex regimens, including multiple pills or injections plus oral meds. They should have no resistance to bictegravir, stable kidney function (not on dialysis), and undetectable HIV levels for at least 6 months. It's not for those with active tuberculosis, prior lenacapavir use, or chronic hepatitis B.

What is being tested?

The study compares the effects of switching to a new regimen of bictegravir plus lenacapavir versus continuing current therapy in Phase 2. In Phase 3, it looks at a fixed-dose combination of these drugs against current treatments in people living with HIV.

What are the potential side effects?

Potential side effects may include gastrointestinal issues like nausea and diarrhea, possible allergic reactions, liver enzyme changes indicating liver health concerns, fatigue, headache and other common drug-related adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Phase 2: PK Parameter: AUCtau of BIC and LEN at Steady State

Structure of lenticular fasciculus

Phase 2: Pharmacokinetic (PK) Parameter: Cmax of Bictegravir (BIC) and Lenacapavir (LEN) at Steady State

Side effects data

From 2015 Phase 1 trial • 23 Patients • NCT02275065

25%

Upper respiratory tract infection

25%

Blood creatine phosphokinase increased

25%

Diarrhoea

25%

Musculoskeletal pain

25%

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Bictegravir 5 mg

Bictegravir 25 mg

Bictegravir 100 mg

Placebo

Bictegravir 50 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC)Experimental Treatment1 Intervention

Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Group II: Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mgExperimental Treatment2 Interventions

Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC).

Group III: Phase 2: BIC 75 mg + LEN 50 mgExperimental Treatment2 Interventions

Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Group IV: Phase 2: Stable Baseline Regimen (SBR)Active Control1 Intervention

Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Group V: Phase 3: Stable Baseline RegimenActive Control1 Intervention

Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bictegravir

2015

Completed Phase 1

~600

Lenacapavir

2018

Completed Phase 1

~60

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Integrase Strand Transfer Inhibitors (INSTIs) like Bictegravir work by blocking the HIV integrase enzyme, which is essential for the viral DNA to integrate into the host cell's genome. This prevents the virus from replicating within the host cells. Capsid Inhibitors, such as Lenacapavir, target the HIV capsid protein, disrupting the virus's ability to assemble and disassemble properly, which is crucial for its replication cycle. These mechanisms are vital for HIV patients as they offer potent suppression of the virus, reduce the viral load, and help in maintaining a better immune function, thereby improving the quality of life and reducing the risk of HIV-related complications.

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