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CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]).
CABENUVA, a co-packaged kit with two separate injectable medicines - Janssen's rilpivirine and
'At Johnson & Johnson, we are dedicated to changing the course of the HIV epidemic through our pursuit of improved therapies and the development of an HIV vaccine,' said
The approval of CABENUVA is based on the pivotal Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 patients from 16 countries. The studies demonstrated that CABENUVA was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period.
CABENUVA was preferred over their previous daily oral therapy by approximately nine out of 10 patients who switched to rilpivirine and cabotegravir long-acting in ATLAS and FLAIR studies. Treatment preference data was collected from ATLAS and FLAIR clinical trial participants who received CABENUVA. In a pooled exploratory analysis of this Intent-to-Treat Exposed (ITT-E) population, 532 patients completed a single-item question at Week 48 (59 participants did not) and 88 percent (523/591) preferred CABENUVA compared with 2 percent (9/591) who preferred their previous antiretroviral (ARV) treatment. The results were descriptive in nature and are not intended to infer clinical significance.
In both ATLAS and FLAIR studies, the most common adverse reactions (Grades 1 to 4) observed in 2 percent of patients receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash and diarrhea. Over the 48-week study period, a total of 4 percent of participants discontinued CABENUVA due to adverse events.
'The once-monthly injections of CABENUVA showed comparable efficacy to daily oral antiretroviral treatment in maintaining viral suppression,' said
The rilpivirine and cabotegravir long-acting injectable regimen is currently under review by the
Dr.
About CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions)
CABENUVA is indicated in
CABENUVA should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine.
The complete regimen combines rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by
INSTIs, like cabotegravir, 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 infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.
Each of these medicines are also approved as once-daily oral tablets for use as a lead-in, to establish the tolerability of cabotegravir and rilpivirine prior to CABENUVA injection. Once-daily oral rilpivirine and cabotegravir tablets may also be used for up to two months in place of monthly injectable CABENUVA therapy when injectable doses are missed. The oral formulation of rilpivirine is also approved for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naive patients 12 years of age and older and weighing at least 35 kg with a viral load 100,000 HIV RNA copies/mL.
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About ATLAS and FLAIR
ATLAS (NCT02951052) is a Phase 3, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity, safety and tolerability of a two-drug regimen of long-acting, injectable rilpivirine and cabotegravir dosed every four weeks compared to continuation of current oral antiretroviral therapy (ART) of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INSTI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed individuals. Patients were required to be virally suppressed for six months or longer, on a first or second regimen, with no prior failure. The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA 50 c/mL per the
FLAIR (NCT02938520) is a Phase 3, randomized, open-label, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity, safety and tolerability of a two-drug regimen of intramuscular, long-acting, injectable rilpivirine and cabotegravir in adults living with HIV who were virologically suppressed following 20 weeks of induction therapy with either dolutegravir/abacavir/lamivudine or dolutegravir plus 2 other NRTIs if patients were HLA-B5701 positive. Patients who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) were then randomized (1:1) to receive either a cabotegravir plus rilpivirine regimen or remain on the current antiretroviral 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).
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Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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