AbbVie Pan Genotype Hepatitis C Cocktail Therapy G/P Enters UK Early Access to Medicines Program (EAMS)

The British Medicines and Health Products Administration (MHRA) recently issued a positive scientific opinion, including the pan-genotype hepatitis C cocktail therapy G/P(glecaprevir mg/pibrentasvir mg, 300mg/120mg) developed by American biotechnology giant AbbVie (AbbVie) into the UK's Early Access to Drugs Program (EAMS), which also makes G/P the first chronic hepatitis C treatment drug selected in the program.

G/P(300mg/120mg) consists of NS3/4A protease inhibitor glecaprevir(G) and NS5A inhibitor pibrentasvir(P), developed for the treatment of hepatitis C in all six genotypes. This cocktail therapy is taken once a day, taking 3 tablets at a time. Currently, G/P is under review by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). If approved, G/P will provide an 8-week, all-oral, once-daily, ribavirin-free (RBV) treatment regimen for all genotyped hepatitis C patients without cirrhosis.

The inclusion of EAMS means that hepatitis C patients in the UK can receive G/P treatment in advance before the EU approves G/P. It is estimated that there are currently around 214000 people with hepatitis C in the UK.

In the phase III clinical study, the G/P 8-week treatment regimen achieved a very high virological cure rate (SVR12, sustained virological response 12 weeks after completion of treatment) in the population of hepatitis C patients without cirrhosis across all 6 genotypes (GT 1-6). In patients with compensated cirrhosis, the G/P 12-week treatment regimen also achieved a very high virological cure rate. In addition, G/P has also achieved very high cure rates in a patient population with limited therapeutic options, including patients with severe chronic kidney disease (CKD). The G/P 12-week regimen also achieved very high sustained virologic response in a historically difficult-to-treat patient population, including hepatitis C patients who had not previously been cured by direct-acting antivirals (DAAs).

The G/P regulatory submission is based on data from eight registry studies in the AbbVie G/P Clinical Development Program, conducted in more than 2300 hepatitis C patients in 27 countries, that evaluated the efficacy and safety of G/P treatment for all six genotypes of hepatitis C, including previously untreated (treatment-naive) and previously treated (treated) patient populations, patients with compensated cirrhosis and those without cirrhosis, a clinically challenging group of refractory patients, such as those with severe chronic kidney disease and those who have not been cured by previous direct-acting antivirals (DAAs).

Previously published data showed that the virological cure rate (SVR12) of the G/P 8-week regimen in the population of patients without cirrhosis and naive genotype 1-6 hepatitis C reached 97.5%(n = 693/711). At the end of November last year, the latest data of the G/P clinical project released by AbbVie at the annual meeting of the American Association for the Study of Liver Diseases (AASLD 2016) showed that G/P had a high therapeutic effect on all six genotypes of hepatitis C, including patients with severe chronic kidney disease (CKD). At the same time, the therapeutic effect was independent of the previous treatment plan received by the patient or whether it was accompanied by compensated cirrhosis.

Chronic hepatitis C (HCV) is common in the patient population with severe chronic kidney disease (CKD), reaching as much as 80% in some regions of the world. Approximately 500000 people in the United States have both chronic hepatitis C (HCV) and chronic kidney disease (CKD). For some hepatitis C patients with severe CKD, particularly genotype 2 and genotype 3(GT2,GT3), no direct-acting antivirals (DAAs) are currently available. In such patients, there remains a significant unmet medical need for the development of a new, safe and effective drug.

In fact, after 2013, the number of patent applications related to hepatitis C in the world showed a slight downward trend, indicating that the global anti-hepatitis C innovative drug technology has matured and enthusiasm is cooling. Looking at the international anti-hepatitis C drug market, since 2013, Gilead, AbbVie, Mercadon and others have successively introduced their own anti-hepatitis C drugs and combinations with excellent curative effects (SVR12 has reached 90-100%) and gradually dominated the market. If you want to highlight the tight encirclement, you need to find another way, starting from the direction of the above mainstream targets, and develop anti-hepatitis C drugs with excellent efficacy.

Some new anti-hepatitis C technologies have also emerged in China, such as the NS4B inhibitor compound patent (WO2016045587) jointly applied by Changzhou Yinsheng Pharmaceutical and Sichuan University, KDAC6 inhibitors (WO2015159097) with anti-cancer and anti-viral activity, and patents related to immunotherapy for hepatitis C. It is expected that these technologies will bring good news to Chinese patients in the future.

News source:http://news.bioon.com/article/6703572.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.