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Product Highlight - VOCABRIA + REKAMBYS
13 Sep 2022
• With VOCABRIA + REKAMBYS, the first and only, complete long-acting injectable regimen, dosed once every 2-months, for virologically suppressed* patients
1,2
• The efficacy you have come to expect from daily HIV regimens 1-3†
• Generally well tolerated, with a low rate of discontinuation 1,2,4
Indication: Cabotegravir in combination with rilpivirine for treatment of HIV-1 in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior failure with agents of NNRTI and INI class.
* HIV-1 RNA <50 copies/mL[1] in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior failure with agents of NNRTI and INI class.
† Monthly VOCABRIA + REKAMBYS has non-inferior efficacy to daily oral ARV therapy. At week 48 (primary endpoint), 1.6% (5/308) of participants on Monthly VOCABRIA + REKAMBYS and 1.0% (3/308) of participants on Daily oral ARV therapy had HIV-1 RNA levels of ≥50 copies/mL (adjusted treatment difference 0.6, 95% CI: -1.2, 2.5).[3]
HIV-1=human immunodeficiency virus type 1; INI=integrase inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor.
References:
1. VOCABRIA Hong Kong Product Characteristics GDS04.
2. REKAMBYS Summary of Product Characteristics. Janssen Healthcare; 2021.
3. Swindells S, et al. Long-acting cabotegravir and rilpivirine efficacy to for maintenance of HIV-1 suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123.
4. Overton ET, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005.
• The efficacy you have come to expect from daily HIV regimens 1-3†
• Generally well tolerated, with a low rate of discontinuation 1,2,4
Indication: Cabotegravir in combination with rilpivirine for treatment of HIV-1 in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior failure with agents of NNRTI and INI class.
* HIV-1 RNA <50 copies/mL[1] in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior failure with agents of NNRTI and INI class.
† Monthly VOCABRIA + REKAMBYS has non-inferior efficacy to daily oral ARV therapy. At week 48 (primary endpoint), 1.6% (5/308) of participants on Monthly VOCABRIA + REKAMBYS and 1.0% (3/308) of participants on Daily oral ARV therapy had HIV-1 RNA levels of ≥50 copies/mL (adjusted treatment difference 0.6, 95% CI: -1.2, 2.5).[3]
HIV-1=human immunodeficiency virus type 1; INI=integrase inhibitor; NNRTI=non-nucleoside reverse transcriptase inhibitor.
References:
1. VOCABRIA Hong Kong Product Characteristics GDS04.
2. REKAMBYS Summary of Product Characteristics. Janssen Healthcare; 2021.
3. Swindells S, et al. Long-acting cabotegravir and rilpivirine efficacy to for maintenance of HIV-1 suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123.
4. Overton ET, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005.
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