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P1101 in HCV Phase III in Genotype 2 Study (A14-301)

Background

Chronic hepatitis C virus (HCV) infection affects an estimated 150 million people worldwide (WHO, 2014). In Asia, the prevalence of genotype 2 can be as high as 60% (WHO, 2014; Wang, 2006).

Hepatitis C is a kind of infection disease caused by body fluid exchange with HCV, and mainly effect liver. The symptoms are minor, even no symptom at the early stage. Symptoms like fever, dark urine, abdominal pain, jaundice and so on may appear sometimes. There are 75% to 85% early stage patients, the virus will stage in their liver for a long time. Hepatitis C may progress to liver disease after years but no symptom at the early stage. Sometimes it will progress to liver cirrhosis. Some patients with liver cirrhosis may experience complications, such as liver failure, hepatocellular carcinoma, esophageal varice, or gastric varice. Patients with liver cirrhosis or liver cancer may consider to receive liver transplant. Hepatitis C is the primary reason to conduct liver transplant. So many patients may experience virus re-activation after liver transplant.

The main aim of treating patients with chronic hepatitis C virus infection is to prevent progressive hepatic fibrosis and associated complications, like end stage liver disease, hepatocellular carcinoma and death, by eradicating viral RNA. Over the past 20 years, the effective use of PEGylated interferon and ribavirin has yielded 70-90% sustained virologic response (SVR, undetectable serum HCV RNA levels at 24 weeks post-treatment) in subjects with chronic HCV genotype 2 infection.

Unmet Medical Needs

Long acting interferon is an important and effective medication in hepatitis treatment extensively. It is combined with oral anti- virus agents for hepatitis C treatment. In recent years, on market oral anti- virus agents are too expensive to burden the cost by patient and government, even though treatment efficacy is quite good in hepatitis C. Long acting interferon express well efficacy in hepatitis C treatment, however, traditional long acting interferon always lead to intolerable side effect. Hepatitis C treatment suspension because of patient’s poor willingness for weekly subcutaneously injection medication, and it will lead to disease progression. P1101 is an optimized form of long acting interferon that allow for convenient once every 2 weeks dosing that is conductive to higher patient treatment compliance and willingness with lower side effect and higher safety compare to traditional long acting interferon. To cure hepatitis C smoothly will decrease financial burden of patients and government.

Incentive of The Trial

Hepatitis C is a serious infectious disease and has been identified as the main cause of cirrhosis and hepatitis. The P1101 of PharmaEssentia product is better than conventional interferons with fewer AEs, high safety and given every two weeks in Phase I and II study results. Phase III study of P1101 for HCV GT2 treatment is ongoing so far. If the trail is successful and license for HCV treatment is approved, P1101 is expected to be the only one on the market for given every 2 weeks and the best purity of long-acting interferon.

Its convenience is a competitive advantage over other weekly interferons used on the market. And its mechanism of hepatitis C treatment is different from DAAs, which regulates the body's immune system as the main treatment mechanism. Doctors and patients will have another option after P1101 is approved for HCV GT2 treatment. Although DAAs are now available on the market, the actual effects and continuing side effects should be observed for 15-20 years. Interferon therapy has been developed for decades in Taiwan. It should be the safest, most conservative and clinically effective treatment by using P1101 instead of traditional IFNs for HCV therapy.