Established safety profile for RUKOBIA (fostemsavir)
Cumulative safety summary (safety population)1*
The safety profile through 336 weeks, approaching 7 years, was consistent with that of the overall study population through 240 weeks1†
- Through Week 336 in the randomized cohort, there were 12 drug-related serious AEs, including 1 fatal drug-related serious AE of immune reconstitution inflammatory syndrome. Through Week 336 in the nonrandomized cohort, there were 4 drug-related serious AEs
- Across both cohorts, the most common AEs leading to discontinuation were due to non-COVID-19 infections (randomized cohort, n=8 [3%]; nonrandomized cohort, n=6 [6%])
- No deaths due to COVID-19 occurred
*All participants who received ≥1 dose of study treatment. Of the 272 subjects enrolled in the randomized cohort, 1 subject who received placebo withdrew from the trial prior to receiving RUKOBIA in the open-label phase of the trial.
†The primary safety assessment of RUKOBIA was based on Week 96 data.
Adverse reactions through ~5 years2,3
Adverse reactions (grades 1-4) reported in ≥2% of randomized participants treated with RUKOBIA + OBT through ~5 years2‡
| Adverse Reaction | RUKOBIA + OBT (n=271)§ |
|---|---|
| Nausea | 11% |
| Diarrhea | 4% |
| Headache | 4% |
| Dyspepsia | 3% |
| Fatigue¶ | 3% |
| 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.3
Three additional adverse events were reported through Week 96#: abdominal pain|| (3%), rash** (3%), and sleep disturbance†† (3%).
Through Weeks 96 and 240, the most common adverse reactions leading to discontinuation were related to infections (3%).3
Serious drug reactions occurred in 3% of participants through Week 96, occurred in 4% of participants through Week 240, and included 3 cases of severe IRIS (through Week 96).3
Drug-related adverse events (randomized cohort)2
- 38% (n=104) of participants in the randomized cohort through Week 96 and 42% (n=113) of participants through Week 240 experienced drug-related adverse events
‡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 from the randomized cohort.
‖Includes pooled terms: abdominal discomfort, abdominal pain, and abdominal pain upper.
**Includes pooled terms: rash, rash generalized, rash maculo-papular, rash pruritic, and dermatitis allergic.
††Includes pooled terms: insomnia, sleep deficit, sleep disorder, abnormal dreams.
AE=adverse event; IRIS=immune reconstitution inflammatory syndrome; OBT=optimized background therapy.
References:
- Aberg JA, Mendo Urbina F, Katlama C, et al. 7-year sustained efficacy, safety, and immunological improvement with fostemsavir-based regimens in individuals with HIV and limited treatment options. Poster presented at: 20th European AIDS Conference; October 15-18, 2025; Paris, France. Poster eP125.
- Data on file, ViiV Healthcare.
- 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
PMUS-FSTWCNT260002
