Cost-effectiveness comparison of lamivudine plus adefovir combination treatment and nucleos(t)ide analog monotherapies in Chinese chronic hepatitis B patients

Zhang, Chi; Ke, Wujian; Liu, Li; Gao, Yanhui; Yao, Zhenjiang; Zhou, Shudong; Yang, Yi

doi:10.2147/dddt.s98200

Cited by 5 publications

(5 citation statements)

References 39 publications

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“…In our study, adefovir and entecavir had no significant effect on TB ( Table 2 ), presumably because they are mainly eliminated via the kidney ( 16 , 28 , 30 ). Even in patients with advanced severe hepatitis, their metabolic burden for elimination seemed to be not great.…”

Section: Discussionmentioning

confidence: 47%

“…Even in patients with advanced severe hepatitis, their metabolic burden for elimination seemed to be not great. Because of the resistance of lamivudine-only therapy and the cost-effectiveness of antiviral agents, combination therapy using lamivudine and adefovir is often recommended ( 30 – 34 ). In the present study, patients subjected to adefovir therapy after lamivudine indeed exhibited higher TB than those with adefovir alone ( Table 2 ), supporting the identified lamivudine effect on hyperbilirubinemia.…”

Section: Discussionmentioning

confidence: 99%

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Lamivudine Therapy Exacerbates Bilirubinemia in Patients Underlying Severely Advanced Hepatitis

Choi

Lee

et al. 2017

ToxicolRes

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Lamivudine belongs to the set of antiviral agents effective against hepatitis B virus infection. Given case reports on liver injuries after certain antiviral agent treatments, this study examined the effects of lamivudine on alanine aminotransferase (ALT) and total bilirubin (TB) using a medical system database. A total of 1,321 patients taking lamivudine alone or with others were evaluated using laboratory hits in an electronic medical system at Seoul National University Hospital from 2005 through 2011. The patients were grouped according to prior ALT results: G#1, ALT < 40 IU/L; G#2, 40 IU/L ≤ ALT < 120 IU/L; G#3, 120 IU/L ≤ ALT < 240 IU/L; and G#4, ALT ≥ 240 IU/L. In G#1 and G#2 patients, lamivudine or adefovir treatment decreased ALT and TB compared to prior values. In G#3 and G#4 patients with three times the upper limit of normal (ULN) ≤ ALT < 15 times the ULN, both ALT and TB were decreased after treatment with lamivudine alone, or adefovir following lamivudine therapy, indicating that lamivudine therapy ameliorated liver functions. However, in G#4 patients who experienced severely advanced hepatitis (ALT ≥ 15 times the ULN, or ≥ 600 IU/L), lamivudine augmented TBmax (6.3→13.3 mg/dL) despite a slight improvement in ALT (839→783 IU/L), indicative of exacerbation of bilirubinemia. Patients who used adefovir after lamivudine also showed a high incidence of hyperbilirubinemia when they experienced severely advanced hepatitis. Treatment with adefovir alone did not show the effect. In conclusion, lamivudine may increase the risk of hyperbilirubinemia in patients with severely advanced hepatitis, implying that caution should be exercised when using lamivudine therapy in certain patient populations.

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Section: Discussionmentioning

confidence: 47%

Section: Discussionmentioning

confidence: 99%

Lamivudine Therapy Exacerbates Bilirubinemia in Patients Underlying Severely Advanced Hepatitis

Choi

Lee

et al. 2017

ToxicolRes

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“…Indeed, a cost-effectiveness study in China showed that LAM monotherapy or in combination with ADV is not cost-effective due the high frequency of genetic resistance which leads to higher costs over the course of disease. Conversely, first-line treatment with ETV was found to be the most cost-effective therapy due to its higher efficacy and low risk of resistance [26]. In 2017, the reimbursement schemes in China were updated to include ETV and tenofovir in the national basic medical insurance reimbursement list, which may reduce the cost burden on patients and increase the utilization of these NAs as preferred first-line therapies [1].…”

Section: Discussionmentioning

confidence: 99%

Long-Term Outcomes in Chinese Patients with Chronic Hepatitis B Receiving Nucleoside/Nucleotide Analogue Therapy in Real-World Clinical Practice: 5-Year Results from the EVOLVE Study

et al. 2019

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Background In China, the optimal management of individuals living with chronic HBV infection (CHB) remains an unmet need. The EVOLVE Study was a 5-year prospective, longitudinal, observational study that compared the clinical outcomes in treatment-naive CHB patients receiving entecavir (ETV) or lamivudine (LAM)-based therapies. Methods Males or females aged ≥18 years, diagnosed with CHB regardless of cirrhosis or hepatitis B e antigen (HBeAg) status were enrolled from tier 2 city hospitals (between 2012–2014). The choice of initial therapy and subsequent treatment modifications was at the discretion of treating physicians. Key outcomes included treatment modifications, virological response (HBV DNA <300 copies/ml) and HBV disease progression. Results Of the 3,408 patients enrolled, 1,807 and 628 received ETV and LAM-based therapy, respectively. The mean age was 39.5 years, 74% were male and 22.9% had cirrhosis. The rate of treatment modification was higher in the LAM-based versus ETV group (25.9% versus 13.7%); viral breakthrough was the most common reason in the LAM-based group versus financial reasons in the ETV group. At week 240, the virological response rate was 73% in both treatment groups. Compared with LAM-based therapy, ETV was associated with a significantly lower incidence of viral breakthrough (12.6% versus 2.1%) and genotypic resistance (10.1% versus 1.2%; P<0.0001 for both); significantly lower risk of HBV disease progression (14.0% versus 10.7%; P=0.0113); and lower rates of progression to decompensated cirrhosis (9.6% versus 6.4%) and hepatocellular carcinoma (1.9% versus 0.8%). Conclusions This real-world, longitudinal study demonstrated a significantly lower risk of HBV-related disease progression, viral breakthrough and resistance with ETV versus LAM-based therapy. ClinicalTrials.gov NCT01726439.

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“…Regarding country perspective, nearly 20 different countries conducted these published HE models. China undertook the largest share (reported in 13 of the 65 studies [27,31,32,34,56,69,[71][72][73][74][75][76][77]), closely followed by the US (10/65 [46-48, 51, 52, 64, 70, 78-80]) and the UK (7/65 [33, 43-45, 49, 54, 81]).…”

Section: Overview Of Included Studiesmentioning

confidence: 99%

Are Published Health Economic Models for Chronic Hepatitis B Appropriately Capturing the Benefits of HBsAg Loss? A Systematic Literature Review

Wigfield¹,

Sbarigia

Hashim³

et al. 2019

PharmacoEconomics Open

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Objectives Sustained hepatitis B surface antigen (HBsAg) loss or 'functional cure' (FC) is considered an optimal treatment endpoint by international clinical guidelines for chronic hepatitis B (CHB), yet rarely is this achieved with current standard of care (SoC). This leads to an under-reporting of FC in clinical trials, observational studies and health economic (HE) models. This paper systematically identifies and assesses how FC is incorporated in published HE models of CHB. Methods A systematic literature review was conducted in PubMed and Embase (conducted February 2019) to review how HBsAg loss is captured in HE models. The following items were extracted: rate of (and transition probabilities to) HBsAg loss, HBsAg loss health state costs, and HBsAg loss health state utilities. Results Sixty-five economics evaluations were identified, and < 50% of these (27/65) incorporated HBsAg loss in their models. Only 15/27 stated HBsAg loss health state costs, 15/27 stated HBsAg loss health state utilities, and 11/27 mentioned treatment-specific transition probabilities to HBsAg loss. The majority of sources these inputs were derived from are not transparent. Conclusions The benefits of FC in current HE models are not well captured, as FC is often not reported or not directly related to modelled treatments. This has the potential for novel agents with higher efficacy compared with SoC to be overlooked and undervalued if their worth is not appropriately communicated. In order to ensure optimal access for patients to new and effective therapies, it is important that the benefits of FC are better assessed and captured within HE models.Peter Wigfield and Urbano Sbarigia contributed equally to the work.The benefits of functional cure in current health economic models are not well captured, as functional cure is often not reported or not directly related to modelled treatments.In order to ensure optimal access for patients to new and effective therapies, it is important that the benefits of functional cure are better assessed and captured within health economic models.

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Cost-effectiveness comparison of lamivudine plus adefovir combination treatment and nucleos(t)ide analog monotherapies in Chinese chronic hepatitis B patients

Cited by 5 publications

References 39 publications

Lamivudine Therapy Exacerbates Bilirubinemia in Patients Underlying Severely Advanced Hepatitis

Lamivudine Therapy Exacerbates Bilirubinemia in Patients Underlying Severely Advanced Hepatitis

Long-Term Outcomes in Chinese Patients with Chronic Hepatitis B Receiving Nucleoside/Nucleotide Analogue Therapy in Real-World Clinical Practice: 5-Year Results from the EVOLVE Study

Are Published Health Economic Models for Chronic Hepatitis B Appropriately Capturing the Benefits of HBsAg Loss? A Systematic Literature Review

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