New hepatitis C therapies approved in Europe

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02/08/2017

Patients with hepatitis C in Europe could soon gain access to two new pan-genotypic treatment options after the European Commission issued approval for AbbVie’s Maviret and Gilead’s Vosevi following an accelerated review.

Maviret is a once-daily regimen that combines two distinct antiviral agents - the NS3/4A protease inhibitor glecaprevir (300mg) and NS5A inhibitor pibrentasvir (120mg) - dosed once-daily as three oral tablets and shown in trials to cure the virus in just eight weeks.

Regulators are allowing its use to treat patients without cirrhosis and who are new to treatment, who comprise the majority of the 71 million people living with chronic hepatitis C virus (HCV) infection globally, as well as those with specific treatment challenges, including those with compensated cirrhosis, severe chronic kidney disease or genotype 3 HCV.

“Maviret offers a new therapy for the majority of HCV patients and removes many complexities of pre-treatment patient evaluation,” noted Stefan Zeuzem, chief of the department of medicine at the JW Goethe University Hospital in Frankfurt, Germany.

Approval is based in part on findings of the In the EXPEDITION-1 study, in which 99 percent of chronic HCV infected patients with genotypes 1, 2, 4, 5 or 6 and compensated cirrhosis (Child-Pugh A) taking the regimen achieved sustained virologic response at 12 weeks (SVR12) post-treatment.

Also of note, these high SVR12 rates were seen following 12 weeks of G/P treatment without ribavirin, while patients those virus strains associated with resistance or with a high quantity of the virus in their bloodstream before treatment initiation were not excluded from the study.

On the safety side, the majority of adverse events were mild and no patients discontinued treatment due to an AE, while the most common AEs (≥10 percent) were found to be fatigue and headache

Gilead’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir; SOF/VEL/VOX) was waved through as the first and only single tablet regimen for patients with any genotype of chronic hepatitis C virus infection who have previously failed therapy with direct-acting antivirals.

The therapy was authorised as a 12-week treatment regimen for patients with any genotype of chronic HCV infection, without cirrhosis or with compensated cirrhosis, who have previously failed therapy with a direct-acting antiviral (DAA)-containing regimen.

A 12-week regimen was also cleared for use in DAA-naïve patients with compensated cirrhosis infected with any HCV genotype, with an option to shorten therapy to eight weeks for those infected with genotype 3. For DAA-naïve patients without cirrhosis, the recommended treatment duration is eight weeks.

“SOF/VEL/VOX has demonstrated high cure rates across a range of DAA-experienced patients, with a simple 12-week single tablet regimen. Availability of SOF/VEL/VOX will have a significant impact for this group of patients, offering them the opportunity to be cured of this disease,” noted Professor Michael Manns, director of the Department of Gastroenterology, Hepatology and Endocrinology, Hannover Medical School, Hannover, Germany.

Clinical data from two Phase III clinical trials involving around 750 HCV patients without cirrhosis or with mild cirrhosis showed that 96-97 percent of those who received Vosevi had no virus detected in the blood 12 weeks post treatment. The most common adverse reactions in patients taking the pill were headache, fatigue, diarrhoea and nausea.

Gilead also announced that the treatment scope of Harvoni (ledipasvir 90mg/sofosbuvir 400mg) has been expanded to include adolescents aged 12 to <18 years with HCV genotype 1, 3, 4, 5 or 6 infection.

HCV infection is considered a major public health challenge, with around 15 million people chronically infected across the UK and the disease representing the most common single cause of liver transplantation in the region.


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