Gilead’s breakthrough Hep C treatment for all genotypes shows outstanding results in clinical trials. HCV New Drug Research reported clinical trial data this week for Gilead’s new powerhouse Hep C treatment, a combination of Sovaldi (sofosbuvir) with velpatasvir, an NS5A inhibitor.
In three phase 3 trials, the power combo provided a durable cure in 98% of patients with Hep C genotype 1-6, in 12 weeks after treatment (SVR was achieved, meaning sustained virologic response). In a fourth study, patients with decompensated cirrhosis taking Gilead’s combo Sovaldi/Velpatasvir plus ribavirin experienced higher cure rates of 94% SVR12, compared with those taking the combo alone.
Bio Pharma stated, the goal is to cure as many Hep C patients as possible, including those with cirrhosis in addition to hepatitis C.
Patient treatment length was for 12 weeks. Treatment side effects with Sovaldi/Velpatasvir had similar adverse events compared with placebo-treated patients, the most common side effects being headache, fatigue, and nausea.
Gilead reports it is planning US and European submissions for the fourth quarter, and, if successful, the combination would be the first all oral pan-genotypic single pill regimen approved for chronic Hep C.
Barclays analyst Geoff Meacham said the 12 week regimen will likely target patients with genotype 2-6, "while Harvoni
will remain the key regimen for genotype 1 patients given its commercial success and shorter 8 week treatment option," according to FierceBiotech
Other pharma companies, AbbVie and Merck are also continuing to develop treatment for pan-genotypic (all genotypes).
New FDA approvals for Hep C treatment are predicted in this coming year, making more treatment options available while driving more competition in the Hep C market. Could more competition effect lowering the cost of Hep C treatment to favor access to more patients? We certainly hope so.
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