AbbVie files Hep C treatment in Europe

AbbVie has submitted its Hepatitis C treatment to the European regulator, a triple-pronged therapy set to rival to Gilead's Sovaldi.

Gilead's hit the US market last year, and is already revolutionising the way Hepatitis C (HCV) is being treated, promising to eradicate the virus from most patients, and cut treatment times and side-effects.

AbbVie's drug can make similar claims, but can go one further in offering interferon-free treatment to patients with the chronic genotype 1 (GT1) variant, the most common sub-type of the disease.

Interferon is a painful injection which often produces side-effects in patients, and is one of the leading reasons some patients delay or refuse treatment once diagnosed with Hepatitis C. That means AbbVie's combination could be a major step forward in increasing the number of patients treated, as well as increasing levels of successful treatment.

The submissions for the drug combination are supported by data from the largest all-oral, interferon-free clinical programme in GT1 patients conducted to date, which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.

"These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen which has the potential to provide a promising advancement for the hepatitis C community in the European Union," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "This regulatory milestone, on the heels of our submission of a New Drug Application in the US, represents an important step for our pipeline."

Cost concerns

Healthcare systems are eager to see rival treatments to Gilead's Sovaldi launched, with the hope that competition in the field may help bring prices down. Gilead has been heavily criticised in the US for the high cost of Sovaldi, which is around $84,000 per patient, or $1000 per pill.

AbbVie is giving few indications yet as to its pricing strategy, but it looks unlikely that its launch will drive down prices substantially. This is a major problem for healthcare systems, as this generation of new drugs will create huge new demand and cost in the disease area.

Three-pronged attack

AbbVie's regimen is a three pronged attack on the Hepatitis C virus: a fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without ribavirin (weight-based), dosed twice daily.

This combination of three different mechanisms interrupts the HCV replication process with the goal of getting the best 'sustained virologic response' rates across different patient populations.

The EMA has granted the drug combination accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333), a designation given to new medicines of major public health interest.

This could shorten the EMA review time by around two months – AbbVie estimates that if approved, the combination could be launched in the first quarter of 2015.

Janssen and Merck

Meanwhile another competitor in the market, Janssen, has just made its own submission to the FDA. It has filed Olysio (simeprevir) for use in combination with Gilead's Sovaldi (sofosbuvir). This combination is aimed at a hard to treat group: genotype 1 chronic hepatitis C (HCV) in adult treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis. Olysio is already approved for use in most major markets, but is still awaiting EU approval.

While Olysio is seen as a potential companion to Sovaldi rather than an outright rival, Merck does have its own contender waiting in the wings.

Merck's combination of MK-5172 and MK-8742 is another regimen promising an interferon free treatment for hard to treat patients. The drug is just beginning phase 3 trials, which will look at sub-populations including patients with chronic kidney disease, HIV/HCV co-infection and cirrhosis.

Links

Sovaldi 'cost effective but not affordable' for NHS

Hep C treatment given Breakthrough Therapy status