Ruzasvir + Rilpivirine = Unknown or no reaction

Study Design

This four part, open label drug interaction study enrolled 44 healthy adults. Parts 1-3 consisted of 2 period fixed sequences assessing the one-way interaction of multiple doses of MK-8408 on single doses of dolutegravir, raltegravir, and rilpivirine, respectively. A single dose of ARV was administered in period one followed by a washout period of three days (for dolutegravir and raltegravir) or ten days (for rilpivirine). In period 2, subjects received 60 mg of MK-8408 for 5 days prior to co-administration of single doses of ARV on day 6. Part 4 was a three period fixed sequence study assessing the two way interaction of multiple doses of MK-8408 and tenofovir disoproxil fumarate (TDF). Subjects received 300 mg of TDF for seven days followed by a washout period of seven days. In period two, subjects received 60 mg of MK-8408 daily for six days, and after no washout period, the third period consisted of subjects receiving daily doses of MK-8408 60 mg and TDF 300 mg for seven days. Blood samples were collected for PK analysis of ARV in parts 1-4 and MK-8408 in part 4.

Study Results

Co-administration of MK-8408 did not meaningfully affect the pharmacokinetics of rilpivirine with GMRs of AUC and Cmax close to 1 (actual data not provided). To see results of other aspects of this study, please see specific drug interaction profiles in this database.

Study Conclusions

References

W Gao, J Talaty, L Arrington, G Garrett, Marshall WL, Kim ND, et al. No clinically relevant interaction of mk-8408 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.