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The company will resume development of islatravir for HIV treatment but abandons monthly oral PrEP.
The HIV regimen failed only a few study participants.
A mid-stage trial of the experimental drug islatravir plus Pifeltro did not see notable shifts in measures of kidney function.
This is according to a three-year study in which people switched from a stable HIV regimen to Delstrigo.
None of the people who experienced virologic failure on regimens containing the experimental drug had a viral load of 200 or higher.
A mid-stage trial shows islatravir plus Pifeltro shows promise as two-drug HIV regimen.
A mid-stage trial showed the combo suppressed HIV, was well tolerated and resulted in a low rate of virologic failure.
Merck’s experimental HIV drug proves effective and well tolerated
These medications can now be used by people on stable antiretroviral treatment with undetectable viral load.
This finding did not vary based on the dose of the nucleoside reverse transcriptase translocation inhibitor, formerly called MK-8591.
An OK would add an indication for the use of these HIV medications among those switching from stable regimens.
Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) includes Pifeltro (doravirine) in a three-drug single-tablet regimen.
Compared with a regimen based on Prezista, doravirine was better for blood lipids, including cholesterol and triglycerides.
The new drug application is for doravirine as both an individual tablet and part of a combination tablet.
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