Clinical utility of entecavir for chronic hepatitis B in Chinese patients

Wang, Jiyao

doi:10.2147/dddt.s41423

Cited by 12 publications

(5 citation statements)

References 53 publications

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“…The basic patent for ETV-Brand in the USA was invalidated in 2014 [ 28 ]. In China and Brazil, the basic patents expired in 2011 [ 29 ]. In terms of price, generic ETV can be more feasible in developing or undeveloped country [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

RETRACTED ARTICLE: Analysis of antiviral efficacy after switching from brand to generic entecavir in patients with treatment-naïve chronic hepatitis B

Hsu

2022

BMC Gastroenterol

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Background/Aims Entecavir (ETV) can suppress chronic hepatitis B (CHB) virus replication as a standard of treatment drugs. For the treatment of CHB, affordable generic drugs may be more widely used in developing and undeveloped countries. However, there is little real-world data regarding the clinical efficacy of switching from entecavir-brand-name drugs (ETV-Brand) to entecavir generic drugs (ETV-Generic) with 0.5 mg once daily. The aim of the study was to evaluate the antiviral activity and safety of ETV-Generic in comparison to ETV-Brand in CHB-patients. Methods In this single-center, retrospective, 175 treatment-naïve—CHB-patients were assigned to receive 0.5 mg of ETV-Brand per day for a least 2 years and then switched to ETV-Generic for 6 months for analysis. The primary efficacy endpoint was a sustained virological response in comparison of the rate of undetectable serum Hepatitis B deoxyribonucleic acid (HBV DNA) as the sustained virologic response at baseline and 6 months after switching. Secondary efficacy endpoints were the comparison of the alanine aminotransferase (ALT) levels between before and after switching and ALT normalization. Renal safety consideration was reported on changing the estimated glomerular filtration rate. Results From baseline to 6 months, the rate of undetectable HBV DNA and ALT levels remained stable as compared ETV-Brand period with ETV-Generic for 6 months. The rate of undetectable HBV DNA were 81.1%in ETV-Brand versus 88.0%in ETV-Generic (p = 0.05 CI 0.1–13.5%). ALT levels were 27.2 IU/L (CI 24.8–29.6 IU/L) in ETV-Brand versus 26.2 IU/L (CI 24.0–28.4 IU/L) in ETV-Generic (p = 0.55). Both endpoints were not significantly different between ETV-Brand and ETV-Generic treatments. Kidney function did not significantly differ from ETV-Brand (80.8, interquartile range [IQR]: 66.6–95.3 mL/min/1.73 m2) to ETV-Generic treatment period (80.3, IQR: 65.6–93.5 mL/min/1.73 m2). Conclusion In treatment-naïve CHB-patients, the efficacy and safety profiles of switching from ETV-Brand to ETV-Generic showed no difference. Concluding the ETV-Generic comes to exciting virologic responses and rare adverse events.

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Section: Discussionmentioning

confidence: 99%

RETRACTED ARTICLE: Analysis of antiviral efficacy after switching from brand to generic entecavir in patients with treatment-naïve chronic hepatitis B

Hsu

2022

BMC Gastroenterol

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“…Moreover, among the 182 patients who were prescribed with entecavir and were also measured with medium or low adherence, approximately half of them (50.5%) indicated ‘Medication(s) are expensive and difficult to afford’ and/or ‘Insurance does not provide coverage when cost exceeds the limit’ as the barrier for taking NUCs. Although entecavir has a higher cost, research has shown that entecavir is still more cost-effective than other NUCs [38]. One study evaluated the cost-effectiveness of NUCs in China, and assessed the thresholds at which the drugs would be cost-saving to the national treatment program [39].…”

Section: Discussionmentioning

confidence: 99%

Adherence and perceived barriers to oral antiviral therapy for chronic hepatitis B

Liu

Farazi

et al. 2018

Global Health Action

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Background: Globally, of the 248 million people chronically infected with the hepatitis B virus (HBV), 74 million reside in China. Five oral nucleot(s)ide analogs (NUCs) have been approved for the treatment of chronic hepatitis B (CHB) in China. Objectives: The aims of this study were to determine rates of adherence to NUC therapy in patients with CHB, to identify the self-perceived barriers to adherence, and to examine the factors associated with adherence. Methods: Questionnaire-based interviews were administered among Chinese patients with CHB at hepatology clinics of a tertiary hospital in the city of Wuhan, China. Adults aged 18 years or older prescribed with NUCs were recruited and interviewed to complete a 27-item questionnaire in a private setting, and adherence was measured using the Morisky Medication Adherence Scale (MMAS-8). Results: Among 369 participants, only 16.5% had high adherence (score of 8), 32.2% had medium adherence (score of 6 to <8), and 51.2% were measured with low adherence (score of <6). A logistic regression model was used to determine the factors associated with medication adherence. Significant predictors of high adherence consisted of urban residency, non-cirrhotic status, not using prescribed pills other than HBV medications, and reminders from family members. The five most common reasons for skipping NUCs were that medication(s) are expensive (48.7%), forgetfulness (45.1%), have experienced or worry about potential side effects (19.8%), do not want others to know about my medication(s) usage (18.5%), and ran out of pills and do not have time to refill (15.9%). Conclusions: This study revealed that adherence rates to oral antiviral therapy were far from optimal. This finding should generate public attention, and it would be beneficial for interventional programs to target Chinese patients from rural regions, as well as patients with low socioeconomic status, cirrhosis, and taking multiple medications.

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“… 11 China is one of the countries with a high incidence, millions of patients with liver dysfunction undergo surgery annually. 12 Therefore, patients with diverse liver dysfunction are common in clinical practice in China. 13 Various physiological functions of the liver may be affected by liver dysfunction, such as material metabolism, bile synthesis and secretion, detoxification, and immune response.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic Study of Nalbuphine in Surgical Patients Undergoing General Anesthesia with Varying Degrees of Liver Dysfunction

Gao¹,

Nie²,

Gao³

et al. 2022

DDDT

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This study aimed to characterize the pharmacokinetics of nalbuphine in patients undergoing general anesthesia with varying degrees of liver dysfunction. Patients and Methods: Twenty-four patients were enrolled and divided into three cohorts based on liver function: normal liver function (n = 13), mild liver dysfunction (n = 5), and moderate/severe liver dysfunction (n = 6). During the induction of anesthesia, they received 15 mg of nalbuphine intravenously. Venous blood samples were collected from each patient. The plasma concentration of nalbuphine was determined using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). The pharmacokinetic parameters of nalbuphine were calculated by non-compartmental analysis (NCA) using Phoenix WinNonlin software. Results: Compared with the normal liver function group, the plasma elimination half-life (T 1/2 ) of nalbuphine was increased by approximately 33% in the moderate/severe liver dysfunction group (2.66 h vs 3.54 h, P<0.05), and the volume of distribution (V d ) increased by approximately 85% (100.08 L vs 184.95 L, P<0.05). Multivariate analysis revealed that weight and platelet were associated with clearance (CL); total bilirubin as an independent factor was associated with T 1/2 , and weight associated with area under the curve (AUC (0→∞) ) independently. Conclusion:The T 1/2 , mean residence time, and V d of nalbuphine in patients with moderate/severe liver dysfunction were prolonged or increased significantly compared with those in the normal liver function group. These data suggest that it may need to be used with caution when nalbuphine is administered to patients with moderate or severe liver dysfunction.

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Clinical utility of entecavir for chronic hepatitis B in Chinese patients

Cited by 12 publications

References 53 publications

RETRACTED ARTICLE: Analysis of antiviral efficacy after switching from brand to generic entecavir in patients with treatment-naïve chronic hepatitis B

RETRACTED ARTICLE: Analysis of antiviral efficacy after switching from brand to generic entecavir in patients with treatment-naïve chronic hepatitis B

Adherence and perceived barriers to oral antiviral therapy for chronic hepatitis B

Pharmacokinetic Study of Nalbuphine in Surgical Patients Undergoing General Anesthesia with Varying Degrees of Liver Dysfunction

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