Outcome of adefovir add‐on lamivudine rescue therapy of up to 5 years in patients with lamivudine‐resistant chronic hepatitis B

Kim, Sung‐Bae; Kim, Seung Up; Park, Jun Yong; Ahn, Sang Hoon; Han, Kwang Hyub

doi:10.1111/jgh.13046

Cited by 7 publications

(4 citation statements)

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“…However, according to the study conducted in Korea, complete virological response (CVR) was achieved only in 32.4% during ADV and LAM combination (referred as ADV+NA) therapy in LAM-resistant patients [ 12 ]. In another study, cumulative rates of CVR were 29.9% at 1 year and 86.9% at 5 years by ADV+NA therapy [ 13 ]. Therefore, for patients who did not achieve CVR during ADV+NA therapy for NA-resistant strains, appropriate alternative regimens to achieve the better CVR rates should be required based upon the current paradigm of CHB treatment.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of switching from adefovir to tenofovir in chronic hepatitis B patients who exhibit suboptimal responses to adefovir-based combination rescue therapy due to resistance to nucleoside analogues (SATIS study)

et al. 2016

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Background/AimsIt remains to be determined whether switching from adefovir (ADV) to tenofovir (TDF) provides better virological outcomes in patients exhibiting suboptimal responses to ADV plus nucleoside analogue (ADV+NA) therapy for NA-resistant chronic hepatitis B (CHB).MethodsIn this prospective trial, patients who showed partial responses (defined as serum hepatitis B virus [HBV] DNA >60 IU/mL) to ADV+NA therapy for NA resistance were randomly allocated to receive TDF plus NA (TDF+NA group, n=16) or to continue their current therapy (ADV+NA group, n=16). The primary end point was the proportion of patients with complete virological response (CVR, defined as serum HBV DNA <60 IU/mL) at 48 weeks.ResultsThe median age was 52 years (16 men), and 28 were positive for hepatitis B e antigen (HBeAg). The baseline characteristics did not differ significantly between the two groups. The proportion with CVR was significantly higher in the TDF+NA group than in the ADV+NA group at 24 weeks (81.3% vs. 25.0%, P=0.001) and 48 weeks (87.5% vs. 37.5%, P=0.002). Furthermore, a decrease in the serum HBV DNA level of >2log10 IU/mL was more likely in the TDF+NA group at both 24 and 48 weeks (68.8% vs. 56.3%, P=0.014 vs. 81.3% vs. 56.3%, P=0.001, respectively). During the follow-up, the rate of HBeAg seroconversion was higher in the TDF+NA group than the ADV+NA group (12.5% vs. 6.25%, P=0.640), as was that for the hepatitis B surface antigen (6.25% vs. 0%, P=0.080). No serious adverse events due to antiviral agents occurred.ConclusionIn patients exhibiting suboptimal responses to ADV+NA therapy for NA-resistant CHB, switching from ADV to TDF might provide better virological outcomes.

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Section: Introductionmentioning

confidence: 99%

Efficacy of switching from adefovir to tenofovir in chronic hepatitis B patients who exhibit suboptimal responses to adefovir-based combination rescue therapy due to resistance to nucleoside analogues (SATIS study)

et al. 2016

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“…Nevertheless, ADV use as a rescue therapy is affected by a primary non-response in 8–15% of patients. In a study of ADV add-on LAM rescue therapy in lamivudine-resistant patients, Kim et al [ 152 ] reviewed 167 patients with ADV add-on rescue treatment for 5 years. After 5 years treatment 86.9% patients had complete virological response.…”

Section: Goals and Endpoints Of Antiviral Treatment For Hbv-related Cmentioning

confidence: 99%

Antiviral Therapy for AECHB and Severe Hepatitis B (Liver Failure)

Ning

et al. 2019

Acute Exacerbation of Chronic Hepatitis B

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This chapter describes the principles of antiviral therapy, treatment strategies, medications and recommendations for AECHB, HBV-ACLF, HBV-related liver cirrhosis, HBV-related HCC, and liver transplantation. Severe exacerbation of chronic hepatitis B is closely related to continuous HBV replication. Therefore, inhibiting HBV replication to reduce viral load may block disease progression and improve the quality of life of these patients. ETV or TDF has been recommend first-line drug for the treatment of AECHB. A hyperactive immune response due to continuous HBV replication is the main mechanism for development of severe hepatitis B. In addition to comprehensive treatment, early administration of potent nucleoside analogs can rapidly reduce HBV DNA concentration, relieve immune injury induced by HBV, and reduce liver inflammation and patient mortality. Antiviral agents have become important in the treatment of severe exacerbation of chronic hepatitis B. Long-term antiviral treatment with nucleoside analogs can delay or reverse the progress of liver cirrhosis. Virologic response, viral resistance and adverse drug reactions should be closely monitored during treatment. The treatment should be optimized for maximum effect based on each patient’s responses. Effective antiviral therapy can suppress HBV replication and reduce the incidence of HBV-related HCC. Patients with HBV-related HCC should receive individualized and optimal multidisciplinary comprehensive treatment. Anti-viral drugs with high efficacy, low resistance and low adverse drug reactions should be selected to improve the patient’s quality of life and prolong survival time. Methods to prevent HBV reinfection after liver transplantation include passive immunization (HBIG), antiviral treatment (nucleoside analogs) and active immunization (hepatitis B vaccine). Clinical trials involving sequential combination therapy with NUC and Peg-IFN have shown statistically significant decline in HBsAg levels on treatment and high rates of sustained post-treatment serologic response. Combination therapy with novel DAA and immunotherapeutic approach may hold promise to overcome both cccDNA persistence and immune escape, representing a critical step towards HBV cure.

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“…Drug resistance was reported in 26% of CHB patients treated with adefovir, after 5 years[ 8 ]. The resistance rate of adefovir in patients with lamivudine resistance who were given adefovir add-on lamivudine rescue therapy was 6% at the end of 5 years[ 50 ]. To optimize therapy in lamivudine-resistant patients, it is recommended not to discontinue lamivudine therapy for a while after initiating adefovir[ 8 ].…”

Section: Adefovir Dipivoxilmentioning

confidence: 99%

Adverse effects of oral antiviral therapy in chronic hepatitis B

Kayaaslan

Güner

2017

WJH

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Oral nucleoside/nucleotide analogues (NAs) are currently the backbone of chronic hepatitis B (CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects (i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a “Black Box” warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. Adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus (HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment.

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Outcome of adefovir add‐on lamivudine rescue therapy of up to 5 years in patients with lamivudine‐resistant chronic hepatitis B

Abstract: Complete virological response or HBV DNA level < 800 IU/mL after 1 year adefovir add-on lamivudine rescue therapy can favorably predict CVR.

Cited by 7 publications

References 34 publications

Efficacy of switching from adefovir to tenofovir in chronic hepatitis B patients who exhibit suboptimal responses to adefovir-based combination rescue therapy due to resistance to nucleoside analogues (SATIS study)

Efficacy of switching from adefovir to tenofovir in chronic hepatitis B patients who exhibit suboptimal responses to adefovir-based combination rescue therapy due to resistance to nucleoside analogues (SATIS study)

Antiviral Therapy for AECHB and Severe Hepatitis B (Liver Failure)

Adverse effects of oral antiviral therapy in chronic hepatitis B

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