Dasabuvir/Ombitasvir/Paritaprevir/Ritonavir + Norgestimate = Prohibited

Study Design

This was a 2-period, crossover study in 12 healthy subjects to evaluate drug-drug interactions between Paritaprevir/Ritonavir/Ombitasvir + Dasabuvir (ABT-450/r/ABT-267 + ABT-333, also known as 3D regimen) and escitalopram. The 3D drugs were dosed as paritaprevir/ritonavir 150/100mg QD, ombitasvir 25mg QD, and dasabuvir 400mg BID or 250mg BID (the two strengths were from two different formulations which provided similar exposures). The escitalopram dose administered was 10mg.In period 1 escitalopram was given as a single dose, followed by a washout period. During period 2, the 3D regimen was given alone on days 7-20, followed by the 3D regimen + escitalopram on day 21, then the 3D regimen alone on days 22-26. Blood samples for pharmacokinetic (PK) analyses were collected following dosing of escitalopram, 3D regimen, and escitalopram + 3D regimen.

Study Results

Enrollment was stopped early due to grade 3 alanine aminotransferase increase in 2 subjects. This includes participants taking the full 3D regimen as well as the 2D (paritaprevir/ritonavir + ombitasvir).Coadministration of the 3D regimen with ethinyl estradiol and norgestimate is contraindicated.

Study Conclusions

References

R Menon, P Badri, U Das, et al. Drug-drug interactions with direct-acting antiviral combination therapy of abt-450/r, ombitasvir, and dasabuvir. 54th Interscience Conference On Antimicrobial Agents And Chemotherapy. Washington, DC. ; 2014.