antiviral activity, safety, and pharmacokinetics of bictegravir as 10-day monotherapy in hiv-1–infected adults

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GetGudEric432 GetGudEric432

08-09-2022
Medicine

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antiviral activity, safety, and pharmacokinetics of bictegravir as 10-day monotherapy in hiv-1–infected adults

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tutorconsortium31 tutorconsortium31 · Answer 1 · 2022-09-12T19:05:01+02:00

BIC is a novel, potent, unboosted INSTI that demonstrated rapid, dose-dependent declines in HIV-1 RNA after 10 days of monotherapy. BIC was well tolerated, and displayed rapid absorption and a half-life supportive of once-daily therapy in HIV-infected subjects.

What is the result of above study ?

There were 20 participants (n = 4 each group). In comparison to -0.01 for placebo, mean DAVG11 among BIC dosages ranged from -0.92 to -1.61. All BIC dosages were found to significantly lower plasma HIV-1 RNA from baseline at day 11 when compared to placebo (P 0.001); mean decreases ranged from 1.45-2.43 log10 copies/mL.

Increased BIC exposures were associated with a greater decline in plasma HIV-1 RNA on day 11 compared to baseline. By the end of the study, three participants using BIC (50 or 100 mg) had plasma HIV-1 RNA levels below 50 copies/mL. The median t1/2 ranged from 15.9 to 20.9 hours, whereas the median Tmax varied from 1.0 to 1.8 hours on day 1 after dosing and from 1.3 to 2.7 hours on day 10. Through day 17, no participant had primary INSTI-R substitution. BIC was well tolerated; hence, there were no discontinuations.

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