Uprifosbuvir + Dolutegravir = Unknown or no reaction

Study Design

This was a four-part open label drug interaction study in which 54 healthy subjects were enrolled. Parts 1-3 assessed the one way interaction of multiple doses of MK-3682 on single doses of dolutegravir (DTG), raltegravir (RTG) and rilpivirine (RPV), respectively. In period 1, single doses of ARV were administered. Following a washout period of three days (for dolutegravir and raltegravir) or ten days (for rilpivirine). In period 2, subjects received 300 mg of MK-3682 once daily for seven days to achieve steady state and single doses of ARV on day seven. Part four assessed the two-way interaction of multiple doses of MK-3682 and tenofovir (TDF). In period 1, subjects received 300 mg of TDF once daily for seven days, followed by a washout period of 7 days, and received MK-3682 300 mg once daily for seven days in period two. In period three, subjects received MK-3682 300 mg once daily and TDF 300 mg once daily for seven days. Blood samples were collected for PK assessment of ARV in parts 1-4 and MK-3682 and its circulating metabolite M6 in part 4.

Study Results

Coadministration with MK-3682 didn't meaningfully affect the pharmacokinetics of dolutegravir with GMRs for AUC and Cmax close to one (actual data not provided). For results of other arms of this study, please see the individual interactions in which you are interested.

Study Conclusions

References

W Gao, S Glasgow, J Luk, E Rhee, W Marshall, N Kim, et al. No clinically relevant interaction of mk-3682 with the hiv medications: dolutegravir, raltegravir, rilpivirine and tenofovir disoproxil fumarate. 17th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington, DC, USA. ; 2016.