Ombitasvir/paritaprevir/r/dasabuvir vs dolutegravir or abacavir/lamivudine
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Study Design
An open-label, phase 1, multiple-dose study was conducted to evaluate the pharmacokinetics of Ombitasvir(25mg QD)/Paritaprevir(150mg QD)/Ritonavir (100mg QD) + Dasabuvir (250mg BID) (3D regimen) when coadministered with dolutegravir (50mg QD, DTG). Participants were healthy individuals aged 18 to 55 years old. There were 12 total participants in this section of the study.During period 1, participants received DTG on days 1 through 7.After a 7 day washout after Period 1, participants then received the 3D regimen on days 1 to 14 of period 2. From days 15-24 of period 2, participants received 3D regimen in addition to DTG.PK sampling was performed on day 7 of Period 1 and days 14 and 24 of Period 2.
Study Results
DrugCmax GMR (90%CI)AUC GMR (90%CI)C trough GMR (90%CI)Dolutegravir1.219 (1.153-1.288)1.380 (1.295-1.469)1.357 (1.190-1.545)Dasabuvir M1 (metabolite)1.073 (0.979-1.177)0.996 (0.900-1.101)0.879 (0.795-0.972)Dasabuvir1.014 (0.924-1.114)0.983 (0.921-1.048)0.917(0.851-0.987)Ombitasavir0.960 (0.894-1.031)0.952 (0.902-1.004)0.922 (0.867-0.981)Ritonavir0.932 (0.827-1.052)0.852(0.794-0.915)0.720 (0.678-0.764)Paritaprevir0.888 (0.694-1.135)0.835 (0.668-1.042)0.664 (0.585-0.754)
Study Conclusions
The authors stated that the changes in exposure of all agents during coadministration are not clinically relevant. No dosage adjustments are necessary, however, monitoring of DAA efficacy may be warranted due to very wide confidence intervals reported.
References
A Khatri, R Trinh, W Zhao, et al. Drug-drug interactions of ombitasvir/paritaprevir/r plus dasabuvir with dolutegravir or abacavir plus lamivudine. 16th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington, DC. ; 2015.
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