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EFFICACY AND SAFETY

Efficacy of VOCABRIA + REKAMBYS

Every 2-Month VOCABRIA + REKAMBYS demonstrated non-inferior efficacy to monthly treatment at week 48

ATLAS-2M: ITT-E SNAPSHOT VIROLOGIC OUTCOMES*1
Table showing the results of 2M and 1M dosing in the ATLAS-2M study

*Primary efficacy analysis, ITT-E with a 4% non-inferiority margin.
**Adjusted for baseline stratification factors.
†95% confidence interval.1,2

atlas 2m week 96 bar chart

*Primary efficacy analysis, ITT-E with a 4% non-inferiority margin.
**Adjusted for baseline stratification factors.
†95% confidence interval.1,2

Low level of confirmed virologic failure and resistance

1.5% of patients had confirmed virologic failure on Q2M VOCABRIA + REKAMBYS.1,3,4

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/m2.1

Colleague Testimonials

Hear what colleagues say about their experiences with long-acting therapy

CVF=confirmed virologic failure; HIV-1=human immunodeficiency virus type 1; INI=integrase inhibitor; ITT-E=intention-to-treat exposed; Q1M=monthly; Q2M=once every 2 months; RPV=rilpivirine.

References:

  1. VOCABRIA Summary of Product Characteristics. ViiV Healthcare.
  2. Data on file. Secondary efficacy endpoints: REF-77816. ViiV Healthcare group of companies.
  3. 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 ahead of print: December 9, 2020. doi: 10.1016/S0140-6736(20)32666-0.
  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 ahead of print: December 9, 2020. doi: 10.1016/S0140-6736(20)32666-0. Supplementary material.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

REKAMBYS (rilpivirine long acting injection), 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.

PM-GB-CBR-WCNT-210001v3 I April 2022

Prescribing Information

Report an adverse event

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.