Cabenuva is now approved for administration as few as six times a year for virologically suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine

LONDON, UK I February 01, 2022 I ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per millilitre [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the US FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults.1 It contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The US FDA approval allows Cabenuva to be dosed monthly or every two months.

Lynn Baxter, Head of North America at ViiV Healthcare, said: “ViiV Healthcare is pleased to continue our leadership in researching and developing long-acting innovative HIV treatment options that address the evolving needs of the HIV community. Today’s approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year.”

The US FDA approval of long-acting cabotegravir and rilpivirine for use every two months is based on the global ATLAS-2M phase IIIb trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing.2 Non-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA ≥ 50 c/ml using the US FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed population), which showed that the every-two-month arm (9/522 [1.7%]) and once-monthly arm (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6%, 2.2%). The study also found that rates of virologic suppression, a key secondary endpoint, were similar for every-two-month dosing (492/522 [94.3%]) and once-monthly dosing (489/523 [93.5%]) (adjusted difference: 0.8%, 95% CI: -2.1%, 3.7%). The most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving long-acting cabotegravir and rilpivirine were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. In ATLAS-2M, the type and frequency of adverse reactions reported in participants receiving long-acting cabotegravir and rilpivirine once monthly or every two months for 48 weeks were similar. In the every-two-month arm, rates of serious adverse events (SAEs: 27/522[5.2%]) and withdrawals due to adverse events (AEs: 12/522 [2.3%]) were low and similar to those experienced in the once-monthly arm (SAEs: 19/523 [3.6%], withdrawals due to AEs 13/523 [2.5%]).2

Turner Overton, MD, Professor, Department of Medicine at the University of Alabama at Birmingham and ATLAS-2M Primary Investigator, said: “Many people living with HIV face challenges with daily therapies and are interested in alternative dosing options. In clinical trials, approximately nine out of every ten trial participants preferred long-acting cabotegravir and rilpivirine dosed every two months compared to daily oral cabotegravir and rilpivirine taken as the oral lead-in per trial protocol. This preference data highlights the meaningful impact long-acting regimens can have on the treatment experience for the HIV community.”

Patient preference data were collected from clinical trial participants who received long-acting cabotegravir and rilpivirine. In a pooled analysis of this intent-to-treat exposed population with no prior experience with long-acting cabotegravir and rilpivirine, 327 patients completed a single-item question at Week 48, and 92% (300/327) preferred every-two-month injections compared with one per cent (4/327) who preferred oral cabotegravir and rilpivirine that was taken as the required oral lead-in. These results are descriptive in nature and should not be used to infer clinical significance.3

About ATLAS-2M (NCT03299049)
The ATLAS-2M phase IIIb trial is an ongoing, randomised, open-label, active-controlled, multicentre, parallel-group trial designed to assess the non-inferior antiviral activity and safety of long-acting cabotegravir and rilpivirine administered every eight weeks (every two months, 3ml dose of each medicine) compared to every four weeks (once monthly, 2ml dose of each medicine) over a 48-week treatment period in 1,045 adults living with HIV-1.2 Subjects were required to be virologically suppressed for six months or greater, on a first or second antiretroviral regimen, with no prior virologic failure. The primary outcome measure for the trial was the proportion of participants with HIV-1 RNA ≥ 50 c/ml at Week 48 using the US FDA Snapshot algorithm (intent-to-treat exposed population). ATLAS-2M is part of ViiV Healthcare’s extensive and innovative clinical trial programme. It is being conducted at research centres in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States.

For further information, please see

About Cabenuva (cabotegravir, rilpivirine)
Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen. Rilpivirine is approved in the US as a 25mg tablet taken once a day to treat HIV-1 in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35kg with a viral load ≤100,000 HIV RNA c/ml.

INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying.

Long-acting cabotegravir and rilpivirine are approved for use every two months in Canada under the name Cabenuva and in the EU as Vocabria and Rekambys.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Please see full Prescribing Information.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE/NYSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit

About ViiV Healthcare’s Patient Assistance Program
ViiV Healthcare is committed to providing assistance to eligible people living with HIV in the US who need our medicines. ViiV Healthcare’s centralised service, ViiV Connect, provides comprehensive information on access and coverage to help patients living in the US get their prescribed ViiV Healthcare medicines whether they are insured, underinsured or uninsured. ViiV Connect provides one-on-one support from dedicated access coordinators, as well as having an integrated website, one site with many resources, including a portal. For more information on ViiV Connect, visit

About GSK
GSK is a science-led global healthcare company. For further information please visit


  1. Cabenuva (cabotegravir, rilpivirine) Prescribing Information. US Approval January 2022.
  2. Overton E, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomized, multicentre, open-label, phase 3b non-inferiority study. Lancet, 396(10267): 1994-2005. 9 December 2020. doi: 10.1016/S0140-6736(20)32666-0.
  3. Chounta, Vasiliki et al. “Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M).” The patient, 10.1007/s40271-021-00524-0. 31 May. 2021, doi:10.1007/s40271-021-00524-0  

SOURCE: ViiV Healthcare