Dasabuvir/ombitasvir/paritaprevir/ritonavir vs efavirenz, emtricitabine/tenofovir disoproxil fumarate, or dasabuvir/ombitasvir/paritaprevir/ritonavir
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Study Design
This was a phase 1, randomized, multiple-dose, open label, single center study to evaluate drug-drug interactions between paritaprevir/ritonavir + dasabuvir (ABT-450/r + ABT-333, also known as 2D regimen) and efavirenz (EFV), when administered together in healthy subjects. The 2D drugs were dosed as paritaprevir/ritonavir 150/100mg QD and dasabuvir 400mg BID. EFV was administered as Atripla (efavirenz/tenofovir/emtricitabine 600/300/200 mg), given QD. In cohort 1 (n=9), the 2D regimen was given alone on day 0-14 followed by 2D regimen + Atripla on day 14-28. In cohort 2 (n=7), Atripla was given alone on day 0-14 followed by 2D regimen + Atripla on day 14-28. All doses were administered under non-fasting conditions.
Study Results
Coadministration of EFV and the 3D regimen resulted in premature study discontinuation due to adverse events (AE), therefore pharmacokinetic evaluations were not conducted. 3 subjects from cohort 1 and 6 subjects from cohort 2 discontinued the study due to an AE after receiving the 2D regimen + Atripla.Subjects from cohort 2 experienced neurological and gastrointestinal AEs, as well as ALT elevations that coincided with combination dosing of the 2D regimen + Atripla on day 15.
Study Conclusions
Coadministration of EFV with the 3D or 2D regimen is not recommended.
References
A Khatri, T Wang, H Wang, et al. Drug-drug interactions of the direct acting antiviral regimen of abt-450/r, ombitasvir, and dasabuvir with emtricitabine tenofovir, raltegravir, rilpivirine and efavirenz. 54th Interscience Conference On Antimicrobial Agents And Chemotherapy. Washington, DC. ; 2014.
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