Lack of Pharmacokinetic Interaction Between RitonavirBoosted GS9137 Elvitegravir and Darunavirr

1
Lack of Pharmacokinetic Interaction Between
Ritonavir-Boosted GS-9137 (Elvitegravir) and
Darunavir/r

• Anita A. Mathias1, Gong Shen1, Jeff Enejosa1,
• Vanitha Sekar2, Rebecca Mack2, Frank Tomaka2,
• and Brian P. Kearney1

1 Gilead Sciences, Foster City, CA 2 Tibotec
Inc., Yardley, PA
4th International AIDS Conference (IAS) July
22-25, 2007 Sydney, Australia
2
Results
Open-label, multiple dose, three treatment, six
sequence crossover study

• POWER 1 and 2 predefined target DRV Ctau for
  resistant virus (550 ng/mL) Sekar V, et al.,16th
  IAS, Toronto, Canada, 2006, Abstract TUPE0083
• Ctau 5-fold higher than predefined range

Safety All treatment-emergent AEs were Grade 1
except for Grade 2 rash or maculopapular rash
treatment with EVG/r was generally well tolerated
3
Conclusions

• The steady-state PK of EVG or DRV was not altered
  following coadministration of EVG with
  ritonavir-boosted DRV the Ctau of DRV was also
  not affected to a substantial degree
• EVG plus DRV/r can be coadministered without dose
  adjustment
• Treatment with EVG/r alone was generally well
  tolerated