Fixed-dose combination

Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed

Retrieved on: 
Friday, September 20, 2019
AIDS, FDA, Health, Clinical trials, Pharmaceutical, Drugs, Organic compounds, Hepatotoxins, Chemical compounds, RTT, Combination drugs, Nitriles, Gilead Sciences, Fixed-dose combination, Doravirine/lamivudine/tenofovir disoproxil, Reverse-transcriptase inhibitor, Tenofovir disoproxil

PIFELTRO (doravirine, 100 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral agents.

Key Points: 
  • PIFELTRO (doravirine, 100 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral agents.
  • DELSTRIGO is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg).
  • In addition, 91% of participants who switched to DELSTRIGO on Day 1 (ISG) had HIV-1 RNA
  • Overall, the safety profile in virologically suppressed adult participants was similar to that in participants with no antiretroviral treatment history.

Ontario Provides Access to Biktarvy® for the Treatment of HIV

Retrieved on: 
Tuesday, August 6, 2019
AIDS, Health, Infectious diseases, Clinical trials, Pharmaceutical, Chemistry, Health sciences, Esters, Organophosphates, Tenofovir alafenamide, Fixed dose combination, Gilead Sciences, Bictegravir/emtricitabine/tenofovir alafenamide, Gilead, Tablet, Pharmaceutical industry, Fixed-dose combination

With convenient once-a-day dosing of a small single tablet and few pre-screening or ongoing monitoring requirements, BIKTARVY has simplified treatment initiation, and follow-up, over time.

Key Points: 
  • With convenient once-a-day dosing of a small single tablet and few pre-screening or ongoing monitoring requirements, BIKTARVY has simplified treatment initiation, and follow-up, over time.
  • The facility produces active pharmaceutical ingredients (APIs) for the companys investigational compounds as well as for some commercial products including those APIs used in BIKTARVY for HIV.
  • Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc., and was established in Mississauga, Ontario, in 2006.
  • BIKTARVY, GENVOYA, DESCOVY, and ODEFSEY are registered trademarks of Gilead Sciences, Inc., or its related companies.