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Supported by

Cabotegravir + Rilpivirine 3 times a year (CAB4M + RPV4M)

Developer(s)

	ViiV Healthcare Originator https://viivhcmedinfo.com/our-pipeline/interactive-pipeline/
	J&J Originator https://www.jnj.com/CH/fr

Drug structure

Placeholder

Drug information

Associated long-acting platforms

Aqueous drug particle suspension

Administration route

Intramuscular

Therapeutic area(s)

HIV

Use case(s)

Treatment

Use of drug

Ease of administration

Administered by a community health worker

Administered by a nurse

Administered by a specialty health worker

Frequency of administration

Every 4 months

User acceptance

Not available yet.

Dosage

Available dose and strength

Treatment doses not publicly disclosed. CAB ULA 1,600 mg/3 mL IM is the dose used in the PrEP registration study EXTEND 4M. RPV4M dose not disclosed.

Maximum dose

Not disclosed.

Recommended dosing regimen

Not established.

Additional comments

Four-monthly IM co-administration of CAB4M and RPV4M

Dosage link(s)

Not provided

Drug information

Drug's link(s)

Not provided

Generic name

Cabotegravir ultra long-acting formulation, CAB4M, CAB ULA, CAB 3 times a year) + rilpivirine ultra long-acting formulation, RPV4M, RPV ULA, RPV 3 times a year)

Brand name

Not applicable (investigational; no brand name assigned)

Compound type

Small molecule

Drug class/category

INSTI (cabotegravir) + NNRTI (rilpivirine)

Summary

Investigational complete long-acting injectable regimen designed to extend the dosing interval of cabotegravir plus rilpivirine from every one or two months (approved CAB LA + RPV LA) to every four months, that is three administrations per year. CAB ULA is a higher-concentration cabotegravir formulation with at least double the half-life of the approved 200 mg/mL product; RPV ULA is a new rilpivirine formulation from Johnson & Johnson for which no clinical data have been disclosed. The combination is being evaluated against CAB LA + RPV LA in a phase III registrational study (NCT07650916) in virologically suppressed adults and adolescents.

Approval status

Investigational. Not approved in any jurisdiction. The approved Q1M and Q2M regimens (Cabenuva; Vocabria + Rekambys) use different formulations.

Regulatory authorities

Not applicable (no regulatory submission yet).

Safety

CAB ULA (phase I, healthy adults, CROI 2024): favourable tolerability and safety; IM better tolerated than SC. RPV ULA: no public safety data identified as of 1 October 2026.

Efficacy

No efficacy data for the ULA combination yet. Phase III NCT07650916 began recruiting in June 2026 (primary completion estimated September 2029).

Evidence Summary

Not provided

Delivery device(s)

No delivery device

Scale-up and manufacturing prospects

Scale-up prospects

Not publicly available.

Tentative equipment list for manufacturing

Not publicly available.

Manufacturing

Not publicly available.

Specific analytical instrument required for characterization of formulation

Not publicly available.

Clinical trials

CUATRO (222794)

Identifier

NCT07650916

Link

https://clinicaltrials.gov/study/NCT07650916

Phase

Phase III

Status

Recruiting

Sponsor

ViiV Healthcare

More details

This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).

Purpose

A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

Interventions

Intervention 1

CAB ULA

Intervention 2

RPV ULA

Intervention 3

CAB LA

Intervention 4

RPV LA

Countries

Spain

United States of America

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-06-29

Actual Start Date
2026-06-25

Anticipated Date of Last Follow-up
2026-09-25

Estimated Primary Completion Date
2029-09-04

Estimated Completion Date
2029-09-04

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

Children
Adults
Older Adults

Genders

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
No

Comments about the studied populations

Inclusion criteria: Patient Study Participant (PSP) Inclusion criteria: * Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg. * Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening. * HIV-1 RNA \<50 copies/mL at screening assessment. * Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening. * Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL). Exclusion criteria: Patient Study Participant (PSP) Exclusion criteria: * Any evidence of primary resistance based on the presence of any major known INSTI (incl

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

564

Allocation

Randomized

Intervention model

Parallel Assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Monthly

Every 2 months

Studied LA-formulation(s)

Injectable

Studied route(s) of administration

Intramuscular

Use case

Treatment

Key resources

Not provided

Cabotegravir + Rilpivirine 3 times a year (CAB4M + RPV4M)

Developer(s)

Drug structure

Drug information

Associated long-acting platforms

Administration route

Therapeutic area(s)

Use case(s)

Use of drug

Ease of administration

Frequency of administration

User acceptance

Dosage

Available dose and strength

Maximum dose

Recommended dosing regimen

Additional comments

Dosage link(s)

Drug information

Drug's link(s)

Generic name

Brand name

Compound type

Drug class/category

Summary

Approval status

Regulatory authorities

Safety

Efficacy

Evidence Summary

Delivery device(s)

Scale-up and manufacturing prospects

Scale-up prospects

Tentative equipment list for manufacturing

Manufacturing

Specific analytical instrument required for characterization of formulation

Clinical trials

CUATRO (222794)

Identifier

Link

Phase

Status

Sponsor

More details

Purpose

Interventions

Countries

Sites / Institutions

Trials dates

Studied populations

Comments about the studied populations

Health status

Study type

Enrollment

Allocation

Intervention model

Intervention model description

Masking

Masking description

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Key resources

Excipients

Proprietary excipients used

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Residual solvents used

Patent info

Supporting material

Publications

Additional documents

Useful links

Additional information