AbbVie's 3D hepatitis C regimen containing paritaprevir (ABT-450), ombitasvir, and dasabuvir was generally well-tolerated in the Phase 3 PEARL trials, according to a pooled analysis presented at IDWeek 2014 last week in Philadelphia. Serious side effects were uncommon and few people discontinued treatment for this reason.
16 October 2014 | HIVandHepatitis.com
The $63,000 wholesale acquisition cost (WAC) for eight weeks of Harvoni™ (sofosbuvir and ledipasvir) should be extended to 12 and 24-week curative treatment durations.
15 October 2014 | Fair Pricing Coalition
Now that the FDA has approved the Harvoni treatment from Gilead Sciences and a $94,500 price for a 12-week regimen has been established, attention is turning toward AbbVie and the steps the big drug maker must take to win market share. Already, though, some Wall Street prognosticators believe AbbVie may find it daunting.
15 October 2014 | Wall Street Journal
Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.
10 October 2014 | Gilead press release
After sizing up the competitive landscape as rival Gilead ($GILD) races ahead with a new combo treatment, Bristol-Myers has opted to drop its application to gain an approval in the U.S. for asunaprevir, its NS3/4A protease inhibitor, and won't go after an OK to use a combination of daclatasvir and asunaprevir for genotype 1b patients.
07 October 2014 | Fierce Biotech
Johnson & Johnson ($JNJ) is taking a deep dive into antivirals, trading $1.75 billion for private biotech Alios BioPharma to get its hands on a midstage treatment and some early assets that could expand its share of the blockbuster hepatitis C market.
01 October 2014 | Fierce Biotech
The development of BMS-986094 (Bristol-Myers Squibb), a nucleotide-polymerase inhibitor for the treatment of chronic hepatitis C (HCV) infection, was terminated back in August 2012, but a new retrospective review analyzing adverse events provides an in-depth look at the cardiotoxicity associated with the investigational agent. The findings may have profound implications for other drugs in late-stage testing or others approved for use.
29 September 2014 | Medscape (requires registration)
The World Health Organization has published an analysis of the patent situation for new hepatitis treatments, and a call for possible pharmaceutical products for prequalification.
29 September 2014 | Intellectual Property Watch
Gilead Sciences, Inc. GILD, +0.97% today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Harvoni®,an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults.
29 September 2014 | Gilead press release
AbbVie's 3D hepatitis C regimen containing ABT-450, ombitasvir, and dasabuvir was generally well-tolerated in the Phase 3 SAPPHIRE trials, according to a pooled analysis presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy last week in Washington, DC.
15 September 2014 | HIVandHepatitis.com