22 December 2020 - - The European Commission has authorized Rekamby's (rilpivirine injection) in combination with ViiV Healthcare's Vocabria (cabotegravir injection and tablets) in the European Union for the treatment of HIV-1 infection in adults who are virologically suppressed, US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen Pharmaceutical business said.

This authorisation represents the first-time people living in Europe with HIV may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets.

Underscoring the need for a less frequent dosing regimen, the largest global HIV patient-reported outcomes study to-date conducted by ViiV Healthcare, Positive Perspectives Wave 2, found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% (n=1306/2389) would prefer a long-acting regimen.

In addition, 58 % (n=1394/2389) noted that taking daily HIV medication acts as a constant reminder of HIV in their lives, while up to 38% (n=906/2389) of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.

Marketing Authorisation is based on the pivotal Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which included more than 1,200 participants from 16 countries.

The rilpivirine and cabotegravir injection combination is indicated for adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL), on a stable antiretroviral regimen, without present or past evidence of viral resistance to, or virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor classes.

Janssen's long-acting rilpivirine in combination with ViiV Healthcare's long-acting cabotegravir was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's industry-leading portfolio that is centered on delivering innovative medicines for the HIV community.

ATLAS is a Phase 3, open-label, active-controlled, multi-centre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of LA, injectable rilpivirine and cabotegravir dosed every four weeks compared to continuation of current oral anti-retroviral therapy of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor, non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor among virally suppressed individuals.

The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (missing, switch, or discontinuation = failure, intent-to-treat exposed [ITT-E] population).

Participants were required to be virally suppressed for six months or longer, on a first or second regimen, with no prior failure.

The ATLAS-2M study is a Phase 3, randomised, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the non-inferior antiviral activity and safety of long-acting rilpivirine and cabotegravir administered every eight weeks compared to long-acting rilpivirine and cabotegravir administered every four weeks over a 48-week treatment period in 1,045 adults living with HIV-1.

Participants were required to be virologically suppressed for six months or greater, on first or second regimen, with no prior failure. The primary outcome measure for the study is the proportion of participants with HIV-1 RNA ≥50c/mL at Week 48 using the FDA Snapshot algorithm (Intent-to-Treat Exposed [ITT-E] population).

ATLAS-2M is being conducted at research centres in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States.
For further information, please see https: //clinicaltrials.gov/ct2/show/NCT03299049.

FLAIR is a Phase 3, randomised, open-label, multi-centre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting injectable rilpivirine and cabotegravir in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with ViiV Healthcare's Triumeq (abacavir / dolutegravir / lamivudine) compared to continuation of the oral dolutegravir-based treatment regimen.

The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (missing, switch, or discontinuation = failure, intent-to-treat exposed [ITT-E] population).9

The oral formulation of rilpivirine is also licensed for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with a viral load ≤ 100,000 HIV RNA copies/mL.

Rilpivirine long-acting is a prolonged-release suspension for IM injection developed by Janssen Sciences Ireland Unlimited company, one of the Janssen Pharmaceutical Companies of Johnson and Johnson.

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

The EC marketing authorisation marks the second for the long-acting regimen of rilpivirine and cabotegravir with once-monthly dosing licensed by Health Canada under the brand name CABENUVA for the treatment of HIV-1 infection in adults who are virologically stable and suppressed.

Rilpivirine injection used in combination with cabotegravir injection will be the first complete long-acting regimen dosed once-monthly or once every 2-months, for virologically suppressed people living with HIV-1.