“The Liver Week 2023: Gilead Shares Latest Hepatitis B∙C Treatment Knowledge Including Vemlidy and Epclusa”

2023-05-25 04:33:01

Gilead shares the latest treatment knowledge for chronic hepatitis B∙C at ‘The Liver Week 2023’

A view of the Vemlidy Luncheon Symposium. [사진=길리어드]

From the 18th to the 20th, Gilead presented chronic B disease at ‘The Liver Week 2023’ jointly hosted by the Korean Society of Liver and 4 related societies (Korean Society of Hepatobiliary and Pancreatic Surgery, Korean Society for Liver Cancer, Korean Society for Liver Transplantation Research). It was announced on the 25th that the latest treatments for hepatitis B and C were shared through the Luncheon Symposium on Hepatitis and the Chronic Hepatitis C Luncheon Symposium held by Yuhan Corporation, a co-promoter.

In this symposium, Gilead, which has leadership in the field of antiviral drugs, looked at the increased opportunities for early treatment due to the expansion of reimbursement standards for chronic hepatitis B treatment and the role of the treatment drug ‘Vemlidy’, and Yuhan Corporation’s role in treating chronic hepatitis C. As a result, it drew attention by disclosing high sustained viral response (SVR) clinical data and real-world data of ‘Ebclusa’, which was released in Korea last year.

Gilead currently offers a portfolio of innovative therapies for hepatitis B and C. In chronic hepatitis B, following Tenofovir series original drug Viread (ingredient: tenofovir disoproxil fumarate) in 2010, Vemlidi (ingredient: tenofovir alafenamide hemifumarate) with improved safety profile in 2017 ) was released.

In chronic hepatitis C, not only Epclusa (ingredient name Velpatasvir/Sofosbuvir), the only pan-genotype and pan-fibrosis treatment, but also Vosevi (ingredient name Velpatasvir/Sofosbuvir/Voxilaprevir), a re-treatment option With the application of domestic approval and reimbursement, we are striving to solve the unmet demand that could not be treated with the previously approved oral direct-acting antiviral agent (DAA).

▲ Expansion of reimbursement standards for initial treatment of chronic hepatitis B… “The role of early treatment will increase”

At the Vemlidy Luncheon Symposium hosted by Gilead on the 18th, the latest knowledge on chronic hepatitis B treatment strategies and the clinical usefulness of Vemlidy were shared. According to the WHO, 296 million people were chronically infected with hepatitis B in 2019, with 1.5 million newly infected each year. In addition, it was found that the cause of most deaths from chronic hepatitis B was progression to liver cirrhosis and hepatocellular carcinoma, emerging as a global health problem.

Professor Ahn Sang-hoon of the Department of Gastroenterology at Severance Hospital of Yonsei University College of Medicine, who served as the chairperson, introduced the news of the recent expansion of the reimbursement standard for oral antiviral drugs for chronic hepatitis B. Last March, according to the change in the detailed recognition criteria for medical care benefit for oral chronic hepatitis B treatment by the Ministry of Health and Welfare, the criteria for liver AST/ALT levels were set in chronic hepatitis B patients with primary treatment of chronic hepatitis B who showed more than moderate inflammatory necrosis or periportal fibrosis abnormal stage. It has been expanded from 80 to 40 to 80.

In addition, in patients with primary treatment for chronic hepatitis B accompanied by compensated cirrhosis, antiviral treatment can be reimbursed even if only HBV-DNA positive is confirmed. Prof. Ahn emphasized that the treatment strategy should also be considered preemptively so that the opportunity for early treatment of chronic hepatitis B patients can increase thanks to the expansion of the reimbursement standard.

Following this, Professor Kwon Jeong-hyeon of the Department of Gastroenterology at Incheon St. Mary’s Hospital, Catholic University of Korea gave a presentation on the topic of ‘redefining the opportunity for early treatment of chronic hepatitis B’. Professor Kwon said, “In Korea, about 75% of all liver cancer patients are carriers of the hepatitis B virus, and 30 to 40% of chronic hepatitis B carriers develop liver cirrhosis, and 1.5 to 6.6% of liver cirrhosis patients annually develop liver cancer.” Explained.

He said, “The higher the serum HBV DNA level, the higher the incidence of hepatocellular carcinoma, and the risk of hepatocellular carcinoma tends to decrease in patients who achieve early ALT normalization through antiviral treatment.” stressed the importance of treatment.

According to domestic real-world data, in a retrospective study of first-time treatment patients, the number of patients treated with Vemlidy and the cumulative incidence rate of patients with chronic kidney disease progressing to stage 1 or higher were significantly higher than those treated with Entecavir. it was quite low Another domestic real-world study also showed that the antiviral effect was maintained and the ALT normalization rate improved in a patient group who switched to Vemlidy during Viread treatment.

▲ Epclusa, a ‘PI-free agent’ that can be used for pan-genotype and pan-fibrosis

Prof. Kim Young-seok of the Department of Gastroenterology at Soonchunhyang University Bucheon Hospital, who chaired the Luncheon Symposium on the topic of ‘Latest DAA Epclusa’ held on the 20th, introduced the current status of chronic hepatitis C in Korea. In domestic patients with chronic hepatitis C, the incidence rate increased with age, and the number of patients with comorbidities was found to be high.

Korean Society of Liver <2021 C형간염 팩트시트>According to , as of 2019, the number of people diagnosed with hepatitis C in Korea was 380,569, and hepatitis C patients had high blood pressure, liver cirrhosis, cardiovascular disease, and chronic kidney disease.

Yonsei University College of Medicine Severance Hospital Department of Gastroenterology Professor Kim Bum-kyung, titled ‘HCV treatment developed in the era of pan-genotypic DAA: pan-genotype, pan-fibrosis, PI-free treatment options’, discussed Epclusa’s high SVR and potentially low drug interactions and ease of use. explained about

Epclusa is the only PI-free treatment that can be prescribed to patients with chronic hepatitis C regardless of their genotype and degree of liver fibrosis. Compared to PI (protease inhibitor)-containing formulations, the incidence of contraindications to drug interactions due to drug interactions is relatively low, and the treatment process is simplified with a single formulation that is taken once a day for 12 weeks, increasing the convenience of taking it.

Professor Beomkyung Kim introduced the high treatment success rate and safety of Epclusa through ASTRAL phase 3 clinical study and real world data, which served as the basis for approval of Epclusa. In particular, in the ASTRAL-1 clinical study targeting 624 patients with genotypes 1, 2, 4, 5, and 6 without cirrhosis or with compensated cirrhosis, a high treatment success rate (SVR12) of 99% was shown.

A large-scale real-world data study and a clinical study targeting hepatitis C patients in Korea confirmed high treatment success rates and safety. After administering Epclusa to patients with chronic kidney disease accompanied by cirrhosis, which was difficult to treat, they confirmed the result of slight improvement in renal function.

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