AbbVie hopes to advance HCV treatment for genotype 4

AbbVie’s investigational hepatitis C virus (HCV) cocktail has been granted FDA priority review April 23 for the treatment of adult patients with chronic genotype 4 (GT4) HCV infection-the first investigational drug combination for GT4 infection, which accounts for about 6% of HCV cases in the United States.

EltonThe investigational cocktail is an all-oral, interferon-free treatment regimen consisting of a fixed-dose combination of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV).

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“Formulary managers will be carefully evaluating the treatment choice, the real-world data confirming ‘curative’ results consistent with the clinical trial data, and the overall value of a therapeutic alternative versus therapeutic costs plus the avoided costs of ongoing HCV management, fibrosis, and ultimately transplants for many of these patients,” said Jeff Elton, managing director of Accenture Life Sciences.

More investigational trials

Gilead Sciences recently announced results from several phase 2 clinical studies evaluating investigational uses of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) and other Sovaldi (sofosbuvir 400 mg)-based regimens for the treatment of chronic HCV infection in patients with advanced liver disease, including patients with decompensated cirrhosis, patients with fibrosing cholestatic hepatitis C (a rare and severe form of the disease following liver transplantation) and patients with portal hypertension.

“HCV is a bellweather of many of the emerging specialty areas-truly transformative therapies that change life for patients, cost curves for society and health systems, and [have an impact on the] roles of life science companies, payers, and PBM/specialty pharma,” said Elton.

There is a demand for a new calculus of value versus price because of an obligation to assure patients have access to transformative and life-sustaining therapies, Elton explained.

Related:CVS Health commits to Gilead's hepatits C drugs

Cost of these therapies is the area of most active debate.

“‘[Measured] costs’ within a [time period of a] given fiscal year appear higher, but the lifetime costs-especially for an acute chronic disease such as HCV-may be substantially lower, to say nothing of individual quality of life and work productivity,” he said.

“Assuring access to life-transforming new specialty therapies is a real need, while developing economics lenses on value that appropriately compensate innovators for short and long-term value [are also needed],” Elton said. “This has not been the structure of reimbursement for providers or life science companies, but it is the intent of our increasingly value-based healthcare environment. HCV is only one of the first to advance into this area, and we are fortunate to see several new comparable therapies emerging in the industry pipeline.”

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