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Thursday, August 30, 2018

Merck’s HIV-1 treatments DELSTRIGO and PIFELTRO approved by FDA


Merck announced that the U.S. Food and Drug Administration has approved two new HIV-1 medicines: DELSTRIGO, a once-daily fixed-dose combination tablet of doravirine, lamivudine and tenofovir disoproxil fumarate; and PIFELTRO, a new non-nucleoside reverse transcriptase inhibitor to be administered in combination with other antiretroviral medicines. Both DELSTRIGO and PIFELTRO are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food. DELSTRIGO contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B infection. DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS. DELSTRIGO and PIFELTRO are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO. DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to 3TC.
https://thefly.com/landingPageNews.php?id=2784275

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