AbbVie novel treatment makes inroads in hep C and HIV

AbbVie has announced strong sustained virologic response (SVR) rates at phase II for its investigational treatment combining three direct-acting antivirals in difficult-to-treat patients with chronic hepatitis C (HCV) and human immunodeficiency virus type 1 (HIV-1).

This brings AbbVie forward in the already hot HCV drug space, where Gilead’s Sovaldi (sofosbuvir) continues to achieve record returns since its launch last December. Bristol-Myers Squibb’s Daklinza (daclatasvir) was also approved as the first NS5A replication complex inhibitor in Europe in August and the company has high hopes for it in light of its approval for use alongside Sovaldi in certain HCV genotypes.

AbbVie’s three-drug, fixed combination treatment is on track to reach the US and European markets next year and could make $3 billion in peak sales, according to analysts.

The phase II portion of AbbVie’s phase II/III study, TURQUOISE-I, showed patients co-infected with genotype 1 (GT1) HCV and HIV-1 receiving the treatment and ribavirin (RBV) for 12 weeks or 24 weeks achieved SVR rates post-treatment of 93.5 per cent and 90.6 per cent, respectively.

“Patients living with both chronic HCV and HIV have been historically considered more difficult to treat,” said Dr Barry Bernstein, vice president, infectious disease development, AbbVie. “TURQUOISE-I is one of the few dedicated studies looking specifically at this population, who are seen in everyday clinical practice. These data will help us gain a better understanding of how our investigational treatment works in this subpopulation of genotype 1 patients.”

Additionally, results from phase II study, CORAL-I, showed that non-cirrhotic liver transplant patients with recurrent GT1 HCV and new to treatment after transplantation achieved a SVR rate of 97.1 per cent at 12 and 24 weeks post-treatment.

“Recurrence of HCV infection in the new graft post-liver transplantation is universal in those that have the virus prior to transplantation, and can be associated with an aggressive disease course,” explained Dr Paul Kwo, medical director of liver transplantation and professor of medicine, Indiana University School of Medicine. “The high SVR rates seen in CORAL-I are promising and offer valuable information as we continue to assess this regimen within this specific patient population.”

AbbVie’s investigational treatment consists of a combination of ABT-450/ritonavir co-formulated with ombitasvir and dasabuvir, with or without ribavirin. The three direct-acting antivirals, each with a distinct mechanism of action, target and inhibit specific hepatitis C virus proteins in the viral replication process.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.

AbbVie’s New Drug Application to the US Food and Drug Administration (FDA) and Marketing Authorisation Applications to the European Medicines Agency (EMA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic GT1 HCV infection have been accepted and granted priority review by the FDA and validated and granted accelerated assessment by the EMA.

AbbVie’s multinational clinical development programme includes more than 2,300 patients in over 25 countries and is designed to identify ways to maximise response rates in a broad spectrum of patient populations, including those with compensated cirrhosis, liver transplant recipients and those with HIV-1 co-infection.

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