Safety profile for RUKOBIA (fostemsavir)

Safety profile through ~5 years in the BRIGHTE study1,2

Key safety summary at Weeks 96* and 240

Parameter, n (%) Randomized
Cohort
(n=272)		 Nonrandomized
Cohort
(n=99)		 Total
(N=371)
Week 96 Week 240 Week 96 Week 240 Week 96 Week 240
Grade 1-4 drug-related AEs 104 (38) 113 (42) 34 (34) 34 (34) 138 (37) 147 (40)
Drug-related SAEs 9 (3) 10 (4) 3 (3) 3 (3) 12 (3) 13 (4)
AEs leading to discontinuation 14 (5) 17 (6) 12 (12) 13 (13) 26 (7) 30 (8)
Table showing % of participants experiencing adverse events during the trial
  • At Weeks 96 and 240, the most common AEs leading to discontinuation were related to infections (3%)1
  • Serious drug reactions occurred in 3% of participants at Week 96, occurred in 4% of participants at Week 240, and included 3 cases of severe IRIS1

*The primary safety assessment of RUKOBIA was based on Week 96 data.

Adverse reactions2

Adverse reactions (grades 1-4) reported in ≥2% of randomized participants treated with RUKOBIA + OBT at Week 2402†

Adverse Reaction RUKOBIA + OBT (n=271)‡
Nausea 11%
Diarrhea 4%
Headache 4%
Dyspepsia 3%
Fatigue§ 2%
IRIS 2%
Somnolence 2%
Vomiting 2%

The safety and tolerability profile of RUKOBIA + OBT remained consistent with prior observations through 96 weeks, with no new safety trends.1

Three additional adverse events were reported at Week 96‖: abdominal pain (3%), rash (3%), and sleep disturbance (3%).

†Adverse reactions in the nonrandomized cohort were similar to those observed in the randomized cohort. The most common adverse reactions reported in nonrandomized patients at Week 96 were: nausea (6%), diarrhea (6%), vomiting (3%), fatigue (5%), and asthenia (2%). At Week 240, they were nausea (6%), diarrhea (6%), vomiting (3%), fatigue (5%), and asthenia (2%).2

‡Of the 272 patients enrolled in the randomized cohort, 1 participant who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial.

§Includes pooled terms: fatigue and asthenia.

‖The primary safety assessment of RUKOBIA was based on Week 96 data.

Review the dosing and administration for RUKOBIA

Dosing and drug interactions

AE=adverse event; IRIS=immune reconstitution inflammatory syndrome; OBT=optimized background therapy; SAE=serious adverse event.

References:

  1. Aberg JA, Shepherd B, Wang M, et al. Week 240 efficacy and safety of fostemsavir plus optimized background therapy in heavily treatment-experienced adults with HIV-1. Infect Dis Ther. 2023;12(9):2321-2335. doi:10.1007/s40121-023-00870-6
  2. Data on file, ViiV Healthcare.

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