Pharmaceutical drug giant Merck has obtained approval from the Food and Drug Administration (FDA) for two new medications to address HIV.
Pifeltro (doravirine) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI). That medication is paired in a new three-drug single tablet dose to be marketed as Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate).
Both are indicated for treating HIV-1 in adults with no prior anti-retroviral treatment.
The approval for the once-a-day pills come after two double-blind, active-controlled phase 3 trials showed positive results.
In a trial called “Drive-Ahead,” 728 patients were treated with either Delstrigo or Gilead’s Atripla for 48 weeks.
At the end of the study, viral suppression rates were similar with Delstrigo reaching 84% and Atripla achieving 81% suppression.
In addition to edging Atripla on viral suppression, Delstrigo patients saw better results regarding LDL cholesterol and non-HDL cholesterol.
The Delstrigo group also experienced lower incidence of neuropsychiatric adverse issues like sleep problems, dizziness and being able to concentrate more clearly.
While there is currently no cure for HIV/AIDS, the Centers for Disease Control have previously announced that when HIV+ folks stay on their prescribed medications on a daily basis, not only are viral loads lowered to ‘undetectable,’ but ‘undetectable’ means the virus is untransmittable.
Why is this news? Gilead
Why is this news? Gilead already has Biktarvy™ on the market; they beat Merck by at least six months as far as I can see. While new medications are always welcome, I think Merck has a nerve blowing its horn when another pharmaceutical company got there first.