Ethinyl oestradiol/levonorgestrel plus GSK3640254 co-administration did not affect steady&8208;state pharmacokinetics or pharmacodynamics of ethinyl oestradiol and levonorgestrel in healthy female participants. Therefore, co-administration of GSK3640254 and combined oral contraceptives containing ethinyloestradiol/levonorgestrel appears to be well tolerated and suitable for combination use in HIV therapy.
Lack of pharmacokinetic interaction between the HIV-1maturation inhibitor GSK3640254 and combination oralcontraceptives in healthy women
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Study Design
Phase I, open&8208;label, 1&8208;way study assessed pharmacokinetic and pharmacodynamic interactions of GSK3640254 200&8201;mg and ethinyl oestradiol 0.03&8201;mg/levonorgestrel 0.15&8201;mg once daily in healthy female participants who received ethinyl oestradiol/levonorgestrel for 10 days with a moderate&8208;fat meal after which GSK3640254 was added from Days 11 to 21.
Study Results
Phase I, open&8208;label, 1&8208;way study assessed pharmacokinetic and pharmacodynamic interactions of GSK3640254 200&8201;mg and ethinyl oestradiol 0.03&8201;mg/levonorgestrel 0.15&8201;mg once daily in healthy female participants who received ethinyl oestradiol/levonorgestrel for 10 days with a moderate&8208;fat meal after which GSK3640254 was added from Days 11 to 21.
Study Conclusions
Ethinyl oestradiol/levonorgestrel plus GSK3640254 co-administration did not affect steady&8208;state pharmacokinetics or pharmacodynamics of ethinyl oestradiol and levonorgestrel in healthy female participants.
References
Dumitrescu, T, Greene, T, Joshi, S, Xu, J, Johnson, M, Halliday, F, Butcher, L, Zimmerman, E, Webster, L, Pham, T, Lataillade, M, Min, S. Lack of pharmacokinetic interaction between the hiv-1 maturation inhibitor gsk3640254 and combination oral contraceptives in healthy women. British Journal Of Clinical Pharmacology. 2022; 4: 1704-1712.
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