Dolutegravir-based regimens were studied in a Phase 3, treatment-experienced, INSTI-naïve trial1,2
- Baseline characteristics: Median age was 43 years; 68% of patients were male, 42% were of African American/African heritage, 50% were white, 20% had HIV-1 RNA >100,000 copies/mL, 72% had CD4+T-cell counts <350 cells/mm3, 16% had hepatitis B and/or C virus co-infection, and 46% were CDC Class C (AIDS)
- Primary endpoint: Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 (FDA snapshot analysis with 12% noninferiority margin with prespecified tests for superiority)
- Baseline resistance prior to ART: 100% of patients had at least 2-class resistance and 49% were resistant to ≥3 classes
Statistically superior virologic response with dolutegravir at 48 weeks in SAILING (snapshot analysis: proportion of patients with HIV-1 RNA <50 copies/mL)1
Statistically superior difference:
- Treatment difference (7.4% [95% CI; 0.7%, 14.2%]) was primarily driven by the rates of virologic nonresponse (20% for the regimens with TIVICAY vs 28% for the raltegravir regimens)1
High barrier to resistance with dolutegravir is supported by 48-week results in SAILING2
No patients receiving dolutegravir had decreases in susceptibility (>2-fold) to dolutegravir in the resistance analysis data set (n=28 with confirmed PDVF‡ at last visit through Week 48 and having resistance data)
Number of patients with treatment-emergent INSTI substitutions based on the resistance analysis data set through 48 weeks2
Discontinuations Due to AEs
Proportion of patients who discontinued due to adverse events in a treatment-experienced, INSTI-naïve trial2
Adverse Drug Reactions (ADRs)
SAILING—Grades 2 to 4 treatment-emergent adverse drug reactions (≥2% frequency) through 48 weeks
- The only treatment-emergent adverse drug reaction of moderate to severe intensity with at least 2% frequency in either treatment group was diarrhea, 2% (6 of 354) in patients receiving TIVICAY 50 mg once daily + BR* and 1% (5 of 361) in patients receiving raltegravir 400 mg twice daily + BR*
Please see full Prescribing Information for TIVICAY.
- Cahn P, Pozniak AL, Mingrone H, et al; on behalf of the extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013;382(9893):700-708.
- Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.