For virologically suppressed adults with HIV-1. See Full Indication.

Safety of
Every-2-Month CABENUVA

The information below gives an overview of the potential adverse reactions of CABENUVA as observed in ATLAS-2M, including drug-related adverse events, discontinuation rates due to adverse events.

Adverse Reactions



ATLAS-2M: The majority of adverse reactions were Grades 1-2

Injection site reactions (ISRs) were the most common side effect associated with CABENUVA in both arms, the majority of which were mild to moderate and short in duration1,2

ADVERSE REACTIONS* REPORTED IN PATIENTS THROUGH WEEK 961,2

ADVERSE REACTIONS* REPORTED IN PATIENTS THROUGH WEEK 961,2

Pooled analysis of incidence of injection site reactions from  Week 4 to Week 48

*Adverse reactions defined as “treatment-related” as assessed by the investigator.1 Pyrexia included pyrexia, feeling hot, chills, influenza-like illness, body temperature increased.1 Fatigue included fatigue, malaise, asthenia.1 §Musculoskeletal pain included musculoskeletal pain, musculoskeletal discomfort, back pain, myalgia, pain in extremity.1 Sleep disorders included insomnia, poor quality sleep, somnolence.1 Rash included erythema, pruritus, pruritis generalized, purpura, rash, rash-erythematous, generalized, macular.1

AE=adverse event.

  • No new safety signals identified from Week 48 to Week 963
  • Non-injection site-related AEs leading to discontinuation and occurring in >1 patient in either treatment arm were fatigue, pyrexia, headache, presyncope, acute hepatitis B, hyperhidrosis, and abnormal dreams (all with an incidence ≤1%)1

Most common local ISR was pain

ATLAS-2M: ISRs (ALL GRADES) REPORTED IN ≥2% OF PATIENTS THROUGH WEEK 96

  • 1% of patients receiving every-2-month CABENUVA discontinued due to injection-related reasons at 96 weeks2

My primary side effect is soreness on my right side for about two to three days. Over time, it has gotten less tender and sore.

– Jayson, clinical study participant. Compensated by ViiV Healthcare.

Patient experience is not indicative of all patient experiences or trial results.

less than 2%

Of patients across both arms discontinued CABENUVA due to ISRs2,4

The median duration of ISR events was 3 days (IQR: 2-5 days)2

  • >80% of events in both groups resolved within 7 days2
  • 7% lasted >14 days across both groups

IQR=interquartile range.

Patient-reported local ISRs decreased through 96 weeks

Self-reported ISRs could potentially underestimate the true rate of ISRs over time. ISRs may still be present but not reported during the course of the study.

ATLAS-2M: INCIDENCE OF ISRs (ALL GRADES) REPORTED BY VISIT THROUGH WEEK 962

ATLAS-2M: INCIDENCE OF ISRs (ALL GRADES) REPORTED BY VISIT THROUGH WEEK 962

Pooled analysis of incidence of injection site reactions from  Week 4 to Week 48
  • ATLAS patients with prior exposure to once-monthly CABENUVA (n=391) received their first injections on Day 1. The incidence of ISRs reported among patients in this group on Day 1 was 34% for the every-2-month CABENUVA arm and 18% for the once-monthly CABENUVA arm2

References:

  1. CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.
  2. Data on file, ViiV Healthcare.
  3. Jaeger H, Overton ET, Richmond G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomized, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5
  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 randomized, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2020;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0

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