Tämä sivusto vaatii Javascript-tuen toimiakseen. Ole hyvä ja muokkaa asetuksiasi tai käytä eri selainta jatkaaksesi.

      

Poistut nyt GSK:n verkkosivustolta

Tämä linkki vie verkkosivustolle, joka ei ole GSK:n ylläpitämä.  

Jatka

Palaa takaisin

INTRODUCING: EVERY 2-MONTH VOCABRIA (CABOTEGRAVIR) + REKAMBYS (RILPIVIRINE)

Here you can find all the information you need about VOCABRIA + REKAMBYS.

NA

First and only, complete long-acting regimen for HIV-1 1, 2

NA

The efficacy you have come to expect from daily HIV regimens 1-3 *

NA

Preferred by 98% of patients over daily oral therapy in the ATLAS-2M clinical trial 4

At Week 48, 98% of 306 patients with no prior exposure to VOCABRIA + REKAMBYS who responded to the questionnaire preferred every 2-month injections vs 1% of 306 patients who preferred the study daily oral lead-in (1% reported no preference) 4

*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% of participants on Daily oral ARV therapy has HIV-1 RNA levels of ≥50 copies/mL (adjusted treatment difference 0.6, 95% CI: -1.2, 2.5). 3

Efficacy of VOCABRIA + REKAMBYS

Every 2-Month VOCABRIA + REKAMBYS was proven to be non-inferior to Monthly 1, 2, 4

Low level of Confirmed Virologic Failure (CVF) and resistance 1, 3

  • ATLAS-2M: CVF + OVERALL RESISTANCE-ASSOCIATED MUTATIONS [1], [2], [4]

    NA
    • All CVFs retained options for fully active oral regimens 1, 4

    Additional analyses show that the likelihood of CVF may be reduced by exercising caution when considering in patients with a combination of at least 2 of the following: incomplete resistance testing and treatment history; HIV subtype A1/A6; or BMI ≥ 30 kg/m 1, 2

    §Suspected virologic failure time point. 1

Which of your patients may be right for VOCABRIA + REKAMBYS?

Patients who express interest in less frequent dosing, or may benefit from every 2-Month VOCABRIA + REKAMBYS 1, 2, 4

NA

Main clinical requirements for VOCABRIA+ REKAMBYS injections 1, 2

  • Virologically suppressed adults (HIV-1 RNA <50 copies/mL)
  • No present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class
  • No contraindications or potential drug-drug interactions

See SmPC for full list of contraindications and drug-drug interactions.

NA

Patient need and commitment 1, 5-8

  • May express interest in less-frequent dosing, or benefit from it
  • Due to challenges with daily HIV therapy, such as:
    • Fear of disclosure
    • Anxiety with staying adherent
    • Daily reminder of HIV
    • Inconvenience
    • Fatigue with taking daily ARVs
  • Able to commit to every 2-month visits and understands the importance of adhering to the schedule

Talking to your patients

Patient Consultation Guide

This consultation guide may help confirm your patients understanding of a long-acting regimen.

Download guide

NA

These medicinal products are subject to additional monitoring.

VOCABRIA (cabotegravir) injection is indicated, in combination with REKAMBYS (rilpivirine) injection, for the treatment of HIV-1 infection 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 virological failure with agents of the NNRTI and INI class. 1, 2

VOCABRIA and REKAMBYS injections are contraindicated in case of hypersensitivity to the active substance or to any of the excipients and must not be co-administered with rifampicin, rifapentine, rifabutin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, dexamethasone (except as a single dose treatment), St John’s wort or proton pump inhibitors (oral rilpivirine). 1, 2

OAT1/3 can be inhibited by cabotegravir, therefore caution is required when co-dosing with methotrexate. VOCABRIA and REKAMBYS injections are not recommended in HBV patients, and monitoring of liver function is recommended in HCV patients. During pregnancy VOCABRIA and REKAMBYS injections are not recommended unless the expected benefit justifies the potential risk to the foetus. 1, 2

The most frequently reported adverse reactions from ATLAS-2M every 2-month dosing were injection site reactions (76%), headache (7%) and pyrexia (7%). To minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen no later than two months after the final injections of VOCABRIA and REKAMBYS when dosed every 2-month. 1, 2

For all safety information, please refer to the full Summary of Product Characteristics.

References:

  1. VOCABRIA (cabotegravir) Summary of Product Characteristics. ViiV Healthcare, January 2021.
  2. REKAMBYS (rilpivirine) Summary of Product Characteristics. Janssen, February 2021.
  3. Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. 2020; 382(12):1112-1123. doi: 10.1056/NEJMoa1904398.
  4. Overton ET, 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 randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. Published Online December 9, 2020. doi:10.1016/S0140-6736(20)32666-0.
  5. de los Rios P, Okoli C, Punekar Y, et al., Prevalence, determinants, and impact of suboptimal adherence to HIV medication in 25 countries, Preventive Medicine (2020), doi.org/10.1016/j.ypmed.2020.106182.
  6. Okoli C, Brough G, Allan B, et al. Shared Decision Making Between Patients and Healthcare Providers and its Association with Favorable Health Outcomes Among People Living with HIV. AIDS Behav. 2020 Aug 3:1–12. doi:10.1007/s10461-020-02973-4. Epub ahead of print.
  7. Clark L, Karki C, Noone J, et al. Quantifying people living with HIV who would benefit from an alternative to daily oral therapy: Perspectives from HIV physicians and people living with HIV. Popul. Med. 2020;2(September), doi.org/10.18332/popmed/.
  8. Claborn KR, Meier E, Miller MB, Leffingwell TR. A systematic review of treatment fatigue among HIV-infected patients prescribed antiretroviral therapy. Psychol Health Med. 2015;20(3):255-265.
NA

REKAMBYS (rilpivirine long acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under license by the ViiV Healthcare group of companies. All other trademarks are owned by the ViiV Healthcare group.

©2021 ViiV Healthcare group of companies or its licensor.