June 16, 2013

Gilead's Potential Megablockbuster Raises the Bar

By Maxx Chatsko

June 16, 2013

The Food and Drug Administration recently granted Gilead Sciences (NASDAQ: GILD ) priority review for its much-awaited hepatitis C drug sofosbuvir. Current treatments are far from perfect for the 3.2 million people suffering from chronic forms of the disease. This novel oral therapy has a lot going for it, which has some analysts thinking it could potentially hit $5 billion in peak sales. In the following video, Fool contributor Maxx Chatsko explains how Gilead's drug raises the bar for the future of hepatitis C treatment.

As mentioned in the video, AbbVie is also developing a next generation drug for hepatitis C. It has shown tremendous promise in clinical trials, but will it be enough once the company's golden goose, Humira, is cooked? The Fool's brand new premium report on the company answers the high-profile questions that AbbVie investors are asking. Simply click here now to claim your copy today.

Source

Fabris P, et al. Show all

Fabris P, Carlotto A, Bianco TD, Malfatti F, Tramarin A, Miotti MA, Baldo V, Floreani A, Giordani TM, Grasso A.

Journal

Eur J Gastroenterol Hepatol. 2013 Jun 5. [Epub ahead of print]

Affiliation

aDepartment of Infectious Diseases and Tropical Medicine, S. Bortolo Hospital bDepartment of Infectious Diseases, Schio, Vicenza cGastroenterology Unit, Gorizia Hospital, Gorizia dDepartment of Gastroenterology, AASL2, San Paolo Hospital, Savona eInstitute of Hygiene fDepartment of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.

Abstract

INTRODUCTION: Short antiviral therapy has been proposed for patients with chronic hepatitis C, easy genotypes, low fibrosis score, low viral load at baseline, and rapid virological response (RVR). However, this approach is not completely accepted.

OBJECTIVES: The aims of this study were (a) to evaluate the sustained virological response (SVR) in noncirrhotic patients with genotype 2 or 3, achieving an RVR, randomized to receive pegylated-interferon (IFN) α-2b plus ribavirin for either 16 or 24 weeks and (b) to carry out direct cost analysis comparing patients treated for 16 versus 24 weeks.

RESULTS: Of the 142 initially evaluated patients, 130 were enrolled according to the selection criteria, but independent of the viral load. According to the intention-to-treat analysis, SVR was achieved in 104 patients (80%). Logistic regression analysis showed that RVR (P<0.001) and genotype 2 (P<0.03) were the most important factors independently associated with SVR. Among patients with RVR, SVR was comparable between patients treated for 16 weeks and those treated for 24 weeks (86.2 vs. 89.7%, P=NS). The mean direct costs were &OV0556;4003.7 for patients treated for 16 weeks and &OV0556;5676.7 for those treated for 24 weeks, with a 30% difference between the two arms.

CONCLUSION: In patients achieving an RVR, a 16-week treatment with pegylated-interferon plus ribavirin was comparable to a 24-week treatment. Short treatment in patients with RVR allows us to save 30% of the direct costs, independent of the viral load at baseline.

PMID
23743559 [PubMed - as supplied by publisher]

Full text: Lippincott Williams & Wilkins

Source