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For UK Healthcare Professionals

EFFICACY AND SAFETY

ATLAS Trial Results

ATLAS was a Phase 3 trial comparing Monthly VOCABRIA + REKAMBYS to daily oral ARV therapy

ATLAS: TRIAL DESIGN1
ATLAS trial design visual

*Taken together once daily at the same time, with a meal.1

†Cabotegravir: initiation injection, 600 mg (3 mL), then continuation injections, 400 mg (2 mL); rilpivirine: initiation injection, 900 mg (3 mL), then continuation injections, 600 mg (2 mL).1

ATLAS included a range of patients1,2

Monthly dosing is as effective as daily oral ARV therapy

ATLAS: ITT-E SNAPSHOT VIROLOGIC OUTCOMES3
Graphs showing the results of the primary and secondary endpoints from the ATLAS study

*Primary efficacy analysis, ITT-E with a 6% non-inferiority margin.1

†95% confidence interval.1

Low level of confirmed virologic failure and resistance1

Monthly dosing was generally well tolerated, with a low rate of discontinuation

ATLAS: PERCENTAGE OF AEs IN Q1M AND DAILY ORAL THERAPY ARMS OVER 48 WEEKS1
Percentage of adverse events reported in the ATLAS trial

ARV=antiretroviral; Q1M=monthly; AE=adverse event; ISR=injection site reaction; Q2M=every 2 months.

References:

  1. 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; 382:1112-1123 doi: 10.1056/NEJMoa1904398.
  2. Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting monthly VOCABRIA + REKAMBYS cabotegravir + rilpivirine for maintenance therapy: ATLAS Week 48 results. Presented at: Conference on Retroviruses and Opportunistic Infections: March 4-7, 2019; Seattle, WA.
  3. VOCABRIA Summary of Product Characteristics. ViiV Healthcare.
  4. Murray M, Antela A, Mills A, et al. Patient‑Reported Outcomes in ATLAS and FLAIR Participants on Long‑Acting Regimens of Cabotegravir and Rilpivirine Over 48 Weeks. AIDS Behav 24, 3533–3544 (2020). https://doi.org/10.1007/s10461-020-02929-8.

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.