Chronic hepatitis B virus infection in the United States and Western Europe is about $ 16 million. US Centers for Disease Control and Prevention show that in the United States in 2011-2012 there were about 847,000 unprovoked people in the United States that have chronic hepatitis B virus. Standard treatment for chronic hepatitis B virus transplantation is nucleotide / nucleoside analogues (NUC), administered daily for oral dose or interferon injection.
RNAi uses its own DNA sequence for the gene to turn off the gene or "erase" its gene. This process has been promoted as a limited therapy for people with chronic hepatitis B virus, as it is capable of silencing the hepatitis B virus RNA (mRNA), which is an active or chronic hepatitis B virus antigen, such as HBsAg.
The use of RNA in clinical practice is limited to the safety and intravenous administration method. ARO-HBV supplemented with 2 small RNA (siRNAs) for direct synthesis of N-acetyl galactosamine to deliver histoprocytes and hypervariable synthesis of covalently closed circular DNA (cccDNA) and host-integrated viral DNA delivered to the skin for delivery items.
Researchers led by Edward Gain, Professor of Auckland University in New Zealand, MBCHB, MD, FRACP, MNZM, "have a pharmacokinetic effect on ARO-HBV dose in normal healthy adult volunteers with safety, tolerance and chronic hepatitis B viral infections, as well as the ARC-HBV- safety, durability and pharmacodynamic effect of multiple doses. clinical trial information.
All normal healthy volunteers receive 6 cohorts (4 active and 2 placebo) doses 35 mg, 100 mg, 200 mg, 300 mg or 400 mg of the skin. "HBeAg pos, NUC, chronic hepatitis B hepatitis B 2b-5b (n = 4, HBeAg pos or neg, NUC-treated or NUC), monthly doses x 3, 100 mg, 200 mg, 300 mg or 400 mg, – Original and experienced hepatitis B hepatitis (each with 8, 9, n = 4 each) is 300 mg every month. 3. Unpregnant NUCs are accepted from the 1st day.
According to preliminary findings, the HBsAg data (n = 24), which received one-time dose of ARO-HBV or placebo (n = 30) and received a three-month dose of ARO-HBV for patients with chronic hepatitis B hepatitis or onofevir for 6 weeks ), Single or multiple doses up to 400 mg were well tolerated. In addition, patients with chronic hepatitis B virus have HBsAg responses strongly (mean NADIR -1.9 Log10 [-98.7%], range -1.3 [-95.0%] Up to -3.8 Log10 [-99.98%]). In addition, NUC-naïve patients (cohort 8) and NUC-tested patients (cohort 9) showed a similar reduction in HBsAg (cohort 8 for 57 days on average HBsAg dropping [n = 4] -1.7 Log10; Day 57 for Cobalt HBsAg Decrease in Average 9 [n = 4] -1,9 Log10).
Approximately 12% of all subcutaneous injections have led to reactions to light injection sites.
Chief Operating Officer of Arrowhead Bruce Given tells about the preliminary results in the pharmaceutical company's statement: "ARO-HBV at all levels [hepatitis B virus] AROHBV1001 patient types, as well as the ARO-HBV tolerance profile support its development. «
On November 9-13, 2018, the United States Association for the Study of Liver Diseases (AARS) presented a study on the "Early Results of Heroin Chronic Hepatitis (RNA) with HBV". San Francisco, California.