Updated with comment from EASL.
) --The most effective new therapy for hepatitis C -- two pills that could cure nearly every patient treated -- may never see the light of day because the developers of these new medicines,
, seem unable to work together.
Apparently, profits are more important than best patient care.
The new Hep C therapy at issue here combines Bristol's daclatasvir with Gilead's GS-7977. Each is a single pill administered once a day. The
-- an early cure rate of 100% for genotype 1 patients and 91% of genotype 2/3 patients, according to data from a mid-stage study announced Thursday at the European Association for the Study of Liver Disease (EASL) meeting.
A 100% cure rate for genotype 1 patients! Obviously, results can't get better than that.
You'd think there'd be a rush to move the combination regimen of daclatasvir and GS-7977 into a larger, confirmatory phase III trial, but you'd be mistaken. Amazingly, this most promising new treatment for hepatitis C patients may actually be discontinued because Bristol and Gilead can't work together.
Good luck understanding why Bristol and Gilead can't come together to help Hep C patients. The companies can't even agree on the fact that the two companies are not agreeing.
"Given the strong SVR4
early cure data from the combo trial of daclatasvir (DCV) + GS-7977, and in the interest of advancing the science and for the benefit of patients, we were interested in a Phase III collaboration. Unfortunately Gilead was not interested," said Bristol spokeswoman Cristi Barnett.
Gilead spokeswoman Amy Flood responded, "That's not the case. There are a number of new data sets at EASL and we need to evaluate and understand all of them. We're going to do that, and look at the best option or options for proceeding as quickly as possible to advance the best all-oral regimen."
EASL Secretary General Mark Thursz wants to see the two companies work together.
"The combination of daclatisvir and GS-7977 has shown positive results at Phase II. EASL is disappointed that development of this combination has been halted as daclatisvir and GS-7977 promised to deliver a highly effective oral regimen that we hoped would be available to HCV patients soon," said Thursz.
Gilead may have $11 billion worth of reasons for not wanting to hook up with Bristol, as in the money spent by the company to acquire Pharmasset this year and gain control of GS-7977. Gilead spent outrageously to buy Pharmasset in an attempt to dominate the future of Hep C treatment in much the same way it already dominates the HIV market.
Gilead needs to justify that $11 billion and deliver profits and returns to its shareholders. Collaborating with Bristol would more than likely dilute Gilead's Hep C profits, which helps explain why Gilead isn't exactly thrilled to push ahead with the daclatasvir GS-7977 combination.
Instead, Gilead would prefer to combine GS-7977 with GS-5885, another drug it owns 100% that belongs to the same NS5A inhibitor class as daclatasvir. But a lot of work remains to be done on GS-5885; it may not be as safe or as effective as daclatasvir. It could also take longer for this all-Gilead combination to reach the market, which means Hep C patients in need of treatment will suffer.
Bristol is in a similar situation. Without access to GS-7977, the company is likely to move ahead with a combination of daclatasvir and INX-189, which belongs to the same nucleoside, or "nuc" class of drugs as GS-7977. Bristol acquired INX-189 when it bought Inhibitex for $2 billion earlier this year.
Bristol still has a lot of work to do with the daclatasvir-INX-189 combination before it can move into phase III studies, which also potentially means Hep C patients will be waiting longer.
is also working on a regimen combining an NS5A inhibitor with a nuc, but those clinical studies are well behind Bristol and Gilead.
Regardless of who's to blame in this Bristol-Gilead spat, Hep C patients in need of convenient and potent new cures are being hurt. It remains to be seen if leading Hep C doctors, patient advocacy groups or medical societies like EASL will object and pressure the companies to move daclatasvir and GS-7977 into phase III studies as soon as possible.
Drug companies always say patients come before profits, but that feels like nothing more than an empty slogan today.
--Written by Adam Feuerstein in Boston.
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