The authors concluded that the increases in tenofovir PK were modest and not considered to be clinically significant, allowing for co-administration of tenofovir and MK-8408.
Ruzasvir vs dolutegravir, raltegravir, rilpivirine, or tenofovir disoproxil fumarate
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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
Multiple doses of MK-8408 increased TDF AUC and Cmax by 17% and 29% respectively, and C24 by 17%. Co-administration of TDF had no meaningful effect on the pharmacokinetics of MK-8408 (actual results not provided).
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.
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