New Therapies, Off-the-Wall Hypotheticals Swirl in Shifting Hepatitis C Landscape

This week, a pair of major pharmaceutical players received word that Marketing Authoization Applications (MAAs) for their hepatitis C (HCV) therapies had been fast-tracked by the European Medicines Agency. AbbVie’s glecaprevir/pibrentasvir combination and Gilead’s triple combination of sofosbuvir, velpatasvir, and voxilaprevir (SOF/VEL/VOX) were both submitted to the US Food and Drug Administration (FDA) under New Drug Applications in December.

The glecaprevir and pibrentasvir combo from AbbVie showed impressive cure rates in the wealth of trials submitted to the FDA last month, covering over 2,300 patients in more than two dozen countries. In over 700 treatment-naïve patients, the drug cured the disease in 97.5% after just 8 weeks of its suggested 12-week course. Additional top-line results from a Japanese phase 3 CERTAIN-1 study released earlier this month showed the drug curing 105 out of 106 patients with genotype 1 HCV.

Gilead’s SOF/VEL/VOX drug, which combines the two drugs that make up its Epclusa treatment with the investigational pangenotypic NS3/4A protease inhibitor voxilaprevir, also produced promising cure rates in the 97% range in phase 3 trials.

Both drugs received Breakthrough Therapy designations last year, and their makers are hopeful that they will reach market in the United States and abroad within the year, providing hepatitis C patients with effective new treatments and bringing the companies themselves needed sales bumps.

The news of the European regulator’s expedited appraisal comes as the makers face domestic sales shortcomings in the shifting HCV treatment market. Both companies underperformed in the final quarter of 2016. For Gilead, some fault may lie in its hepatitis line: Harvoni and Sovaldi sold a combined 44% less from the prior year (though the introduction of Epclusa might have provided internal competition). HCV drugs made up more than half of the company’s sales in 2015, but were below 40% in 2016.

In light of the political whirlwind surrounding health-care and drug prices in the United States, Peter B. Bach of Sloan Kettering and Mark Trusheim of MIT made a bit of a splash with a hypothetical situation they proposed in an article written for Forbes. The two suggested earlier this year that the US government could buy Gilead outright, for the estimated $156 billion it would cost on the open market, in order to effectively bring down the overall price of HCV treatments and potentially eradicate the disease.

In December, also speaking to Forbes, Gilead CEO John Milligan expressed that there may have been a bit of a misstep in the initial pricing of the company’s existing HCV drugs, which can cost between $500 and $1,000 per pill, but did say that “We priced the product at exactly the same as the existing standard of care, which worked about 50% of the time, and are providing a benefit that, based on real world experience, works about 98% of the time.”

The European MMAs were announced in press releases from AbbVie and Gilead.

Related Coverage:

Hepatitis C Guideline Might Have Too Many Conflicts of Interest

Multi-Genotype Hepatitis C Drug Application Lands in Front of the FDA

Gilead Seeks FDA Approval for New Hepatitis C Treatment