Conference round-up: companies go big on hepatitis C at EASL
pharmafile | April 29, 2015 | News story | Sales and Marketing |Â Â Bristol-Myers Squibb, EASL, Merck, daclatasvir, daklinzaÂ
Big pharma names posted favourable results for hepatitis C treatments as they jostled for position as market leaders at the recent International Liver Congress.
The trial data could prove to be pivotal in their searches for regulatory approval over the coming months, or expand their market share.
Bristol-Myers Squibb’s investigational/ treatment Daklinza (daclatasvir) performed well in the ALLY-1 trial. The Phase III study looked at a 12-week course of Daklinza and Gilead’s Sovaldi (sofosbuvir) combined with ribavirin in 113 patients with chronic genotype 1 hep C, who either had advanced liver cirrhosis or who had already had a recurrence of hep C following a liver transplant.
Some 94% of people with post-transplant infection recurrence and 83% of all people in the study with advanced cirrhosis achieved a sustained response after 12 weeks.
Daklinza is licensed in the UK, in combination with other medicinal products, for the treatment of chronic hepatitis C in adults. In the US, BMS has resubmitted its new drug application for FDA approval.
Merck presented Phase III trial results for the first time on an oral daily ribavirin-free hep combination of investigational treatments grazoprevir and elbasvir in people with hep C genotype 1, and advanced chronic kidney disease (CKD).
The PhaseII/III C-SURFER study found that after 12 weeks of immediate treatment with grazoprevir and elbasvir, 99% of patients receiving grazoprevir plus elbasvir achieved a sustained response. And MSD is also running the ongoing C-EDGE Phase III study. Preliminary results presented at the conference suggest response rates upwards of 89% in sub-groups of patients with genotypes 1, 4 and 6 infections and those who are HIV-positive.
Sovaldi, which gained NICE approval in February, continues to gather clinical trial data. Gilead Sciences presented data confirming its efficacy in some of the most common forms of hepatitis C in the UK. The study of 592 patients demonstrated a response rate of 93% after 12 weeks with Sovaldi across some of the most common type of hepatitis C in England, when used in combination with ribavirin or with pegylated interferon.
AbbVie presented Phase IIIb results of a small study of combinations of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) and Exviera (dasabuvir) in 20 people with hepatitis C and renal impairment. The RUBY-1 study found the two drug regimens achieved 100% sustained response rates after four weeks of treatment – although AbbVie will need further data from larger studies to confirm this. This firm is currently conducting the TOPAZ studies, which will evaluate five-year outcomes following treatment with or without ribavirin in adults with genotype 1 infection.
Abbvie also recently announced PhaseIIb study results of an investigation treatment to treat multiple genotypes that may also allow for treatment durations of as little as eight weeks. These preliminary results in non-cirrhotic GT1 patients after 12 weeks showed a sustained virologic response rate at four weeks post treatment of 99 per cent.
The OPTIMIST trials looked at Janssen’s all-oral, once-daily combination of Olysio (simeprevir) plus Sovaldi. The two Phase III studies looked at the efficacy of the two-drug combination in people with genotype 1 infection without liver cirrhosis (OPTIMIST-1) or with liver cirrhosis (OPTIMIST-2).
After 12 weeks 97% of patients without cirrhosis treated for 12 weeks reached a sustained response, and 84% of patients with cirrhosis achieved a sustained response.
Meanwhile the European Medicines Agency has confirmed there is a risk of severe bradycardia (slow heart rate) or heart block (problems with conduction of electrical signals in the heart) in people taking Harvoni (sofosbuvir/ledipasvir), or Sovaldi and Daklinza, who are also taking the heart drug amiodarone for an irregular heartbeat.
To manage this risk the EMA recommends that amiodarone should only be used in patients taking these hep C medicines if other heart treatments cannot be given. The recommendations follow a review of eight cases reviewed up to April 2015, in which one person died and two required pacemakers. The product information for Harvoni, Sovaldi and Daklinza will be updated.
Lilian Anekwe
Related Content
Merck to acquire Curon Biopharmaceutical’s B-Cell Depletion Therapy
Merck have announced that they have entered into an agreement with private biotechnology company Curon …
Merck and Daiichi Sankyo expand development and commericalisation agreement to include MK-6070
Daiichi Sankyo and Merck (known as MSD outside of the US and Canada) have announced …
CHMP gives positive opinion for Merck’s KEYTRUDA for unresectable or metastatic urothelial carcinoma
Merck (known as MSD outside of the US and Canada) has announced that its anti-PD-1 …
