[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, four-period crossover bioequivalence study of sofosbuvir tablets in healthy subjects under fasting and fed conditions

以瑞阳制药股份有限公司提供的索磷布韦片（规格：0.4g/片）为受试制剂，按生物等效性试验的有关规定，与Gilead Sciences Ireland UC生产的索磷布韦片（商品名：索华迪®，规格：0.4g/片，参比制剂）对比单次口服400mg（空腹/餐后）在健康人体内的吸收速度及吸收程度，评估空腹与餐后状态下分别口服两种制剂的人体生物等效性。

[Translation]

Sofosbuvir tablets (specification: 0.4 g/tablet) provided by Ruiyang Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence study, the absorption rate and extent of a single oral administration of 400 mg (fasting/postprandial) of sofosbuvir tablets (trade name: Sovaldi®, specification: 0.4 g/tablet, reference preparation) produced by Gilead Sciences Ireland UC were compared in healthy humans to evaluate the bioequivalence of the two preparations in humans when taken orally in fasting and postprandial states, respectively.

Start Date15 Dec 2020

Sponsor / Collaborator

Ruiyang Pharmaceutical Co., Ltd.

NCT04774107 / CompletedPhase 1

An Open-label Study to Assess the Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis With HCV Genotype 2 Infection

Primary Objective:
To determine the P1101 pharmacokinetic (PK) profile at the single dose of 400 μg.

Start Date26 Nov 2020

Sponsor / Collaborator

PharmaEssentia Corp.

JPRN-UMIN000038604 / CompletedIIT

Efficacy and safety of Ledipasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 2 Infection - Harvoni in Genotype 2 HCV patients

Start Date31 Mar 2020

Sponsor / Collaborator-

100 Clinical Results associated with Chronic hepatitis C genotype 2

100 Translational Medicine associated with Chronic hepatitis C genotype 2

0 Patents (Medical) associated with Chronic hepatitis C genotype 2

134

Literatures (Medical) associated with Chronic hepatitis C genotype 2

25 Mar 2024·The Korean Journal of Gastroenterology

Comparison of Glecaprevir/Pibrentasvir and Sofosbuvir/Ledipasvir in Patients with Hepatitis C Virus Genotype 1 and 2 in South Korea

Article

Author: Ko, Soon Yeong ; Kim, Hong Soo ; Lee, Sae Hwan ; Song, Myung Joon ; Eun, Hyuk Soo ; Kim, Seok Hyun ; Lee, Byung Seok ; Shin, Hyun Deok ; Chae, Hee Bok ; Kim, Suk Bae ; Song, Il Han ; Kim, Seok Hwan ; Lee, Tae Hee

Background/AimsThis study compared the effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/ledipasvir (SOF/LDV) in real-life clinical practice.MethodsThe data from genotype 1 or 2 chronic hepatitis C patients treated with GLE/PIB or sofosbuvir + ribavirin or SOF/LDV in South Korea were collected retrospectively. The analysis included the treatment completion rate, sustained virologic response at 12 weeks (SVR12) test rate, treatment effectiveness, and adverse events.ResultsSeven hundred and eighty-two patients with genotype 1 or 2 chronic hepatitis C who were treated with GLE/PIB (n=575) or SOF/LDV (n=207) were included in this retrospective study. The baseline demographic and clinical characteristics revealed significant statistical differences in age, genotype, ascites, liver cirrhosis, and hepatocellular carcinoma between the GLE/PIB and SOF/LDV groups. Twenty-two patients did not complete the treatment protocol. The treatment completion rate was high for both regimens without statistical significance (97.7% vs. 95.7%, p=0.08). The overall SVR12 of intention-to-treat analysis was 81.2% vs. 80.7% without statistical significance (p=0.87). The overall SVR12 of per protocol analysis was 98.7% vs. 100% without statistical significance (p=0.14). Six patients treated with GLE/PIB experienced treatment failure. They were all male, genotype 2, and showed a negative hepatitis C virus RNA level at the end of treatment. Two patients treated with GLE/PIB stopped medication because of fever and abdominal discomfort.ConclusionsBoth regimens had similar treatment completion rates, effectiveness, and safety profiles. Therefore, the SOF/LDV regimen can also be considered a viable DAA for the treatment of patients with genotype 1 or 2 chronic hepatitis C.

01 Jan 2024·Journal of the Formosan Medical Association

A therapeutic dose and its pharmacokinetics of ropeginterferon Alfa-2b for hepatitis C treatment

Article

Author: Qin, Albert ; Chen, Chi-Yi ; Kuo, Hsing-Tao ; Tsai, Chan-Yen ; Lo, Ching-Chu ; Chen, Wei-Ming ; Chuang, Wan-Long ; Huang, Yi-Wen

AIMRopeginterferon alfa-2b is a novel mono-pegylated proline-interferon. Its biweekly dosing schema has demonstrated tolerability and clinical efficacy for treating chronic hepatitis in previous clinical studies. This trial evaluates the pharmacokinetics of 400 μg ropeginterferon alfa-2b in patients with chronic hepatitis C virus (HCV) and provides the data to support the clinical utility of ropeginterferon alfa-2b at 400 μg.METHODSSeventeen patients with chronic HCV genotype 2 were enrolled to receive a single injection of 400 μg ropeginterferon alfa-2b plus 14-day treatment of ribavirin. Pharmacokinetics, safety, and HCV RNA reduction/clearance were assessed.RESULTST_max was 154.003 h and T_1/2 was 114.273 h. The C_max was 29.823 ng mL^-1. AUC_last was 9364.292 h∗ng mL^-1 and AUC_inf was 11084.317 h∗ng mL^-1. All adverse events were mild or moderate, and there were no serious adverse events. A 1000-fold reduction in the geometric mean of HCV RNA was observed 14 d after the single injection of ropeginterferon alfa-2b. Two patients achieved clearance of HCV RNA, and the other five patients had HCV RNA levels lower than 200 IU mL^-1.CONCLUSIONRopeginterferon alfa-2b at 400 μg led to PK exposures associated with safety and notable clinical activity in patients with chronic HCV. This study suggests that ropeginterferon alfa-2b at 400 μg is an acceptable dosing regimen for treating chronic HCV and also provides supporting data for the clinical use of ropeginterferon alfa-2b at a higher starting dose for other indications.

01 Nov 2022·JGH Open

A Phase 3 clinical trial validating the potency and safety of an innovative, extra‐long‐acting interferon in chronic hepatitis C

Article

Author: Jun, Dae W ; Qin, Albert ; Zhou, Xinmin ; Mao, Xiaorong ; Zhang, Guo‐Qiang ; Chen, Chien‐Hung ; Chen, Jyh‐Jou ; Lo, Gin‐Ho ; Tsai, Chan‐Yen ; Chen, Pei‐Jer ; Shang, Jia ; Zhang, Wen‐Hua ; Chuang, Wan‐Long ; Lai, Hsin‐Hui ; Xie, Wen ; Dang, Shuangsuo ; Wang, Ting‐Fang ; Zhu, Li‐Ying ; Tseng, Kuan‐Chiao ; Huang, Yi‐Wen ; Kuo, Hsing‐Tao ; Chen, Chi‐Yi ; Lo, Ching‐Chu

AbstractBackground and AimRopeginterferon alfa‐2b is a novel mono‐pegylated, extra‐long‐acting interferon. It is administered infrequently and showed good tolerability and clinical activity for the chronic hepatitis B or C treatment in our previous Phase 2 clinical trials. This study aims to validate the potency and safety of this novel agent in a Phase 3 chronic viral hepatitis setting.MethodsPatients with chronic hepatitis C genotype 2 were randomized to receive subcutaneous injections of ropeginterferon alfa‐2b biweekly or the conventional pegylated interferon alfa‐2b weekly for 24 weeks, combined with ribavirin. The primary endpoint was to assess the safety and antiviral potency of ropeginterferon alfa‐2b by the non‐inferiority in sustained virologic response at 12 weeks after treatment.ResultsA total of 222 patients were enrolled. Ropeginterferon alfa‐2b group showed a favorable safety profile. Side effects that were generally associated with prior interferon therapies, including neutropenia, asthenia, fatigue, alopecia, dizziness, decreased appetite, nausea, flu‐like symptoms including myalgia, pyrexia, and headache, and administration site reactions, were notably less in the ropeginterferon alfa‐2b group. The cumulative incidence of adverse events of special interest was also notably higher in the control group. The primary endpoint was met and ropeginterferon alfa‐2b showed a better SVR12 rate of 79.8% than 71.9% of the control group.ConclusionRopeginterferon alfa‐2b is efficacious and has a favorable safety profile as compared with the conventional pegylated interferon alfa‐2b. This study together with previous Phase 2 data validated ropeginterferon alfa‐2b to be a new treatment option for chronic hepatitis C genotype 2.

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