"Watch out Gilead"
It's a good headline, and a sensible warning since many people have felt that Gilead owns the market for HCV for years to come.
In reality, Gilead will have a good share of the market, but it will also face other increasingly competitive treatment programs and drugs.
....but watch out?
Gilead bought Pharmasett in November 2011, right when 7977 was starting Phase 3 trials. "Sovaldi" (formerly 7977) was approved in early December 2013, so it took just over 2 years to take the drug through phase 3 trials and the approval process. (also keep in mind some of the ION trial cohorts were 24 weeks)
When Merck goes to approval, they will not be a game changer, but merely another efficacious HCV treatment. They may not get the same expedited reviews for DAA's that Gilead or Abbvie will be getting in 2014, or that the currently approved Sovaldi regimens saw in 2013.
My guess is that HCV trial durations will become shorter as dosing periods decrease. Less troublesome side effect profiles could also lend to easier approval process. It is also possible that the expense of treatments could create a drive for faster drug approval for HCV treatments.
The problem is by the time the Merck TX is approved in about 2 years, it too will be facing other treatments, either shorter, more efficacious, or with lower side effect issues. (many of the current treatments in development still have some sides, in spite of being far easier than the old SOC).
~W
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