Combination lamivudine and adefovir versus entecavir for the treatment of naïve chronic hepatitis B patients: A pilot study

Du, Qianqian; Ding, Jiao; Sun, Qingfeng; Hong, Lei; Cai, Fujing; Zhou, Qingqing; Wu, Yanghe; Fu, Rong-Quan

doi:10.12659/msm.889443

Cited by 5 publications

(2 citation statements)

References 29 publications

(24 reference statements)

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“…Viral breakthrough in ETV was very low in many clinical studies. Du et al reported only 1 case in 50 patients in the ETV group who had no response during 104-week follow-up in a recent study [ 15 ], and no ETV drug resistance was found in our study. The rates of viral breakthrough in ETV were much lower than in other groups, and complete viral response in the ETV was highest.…”

Section: Discussionsupporting

confidence: 60%

Comparing Efficacy of Lamivudine, Adefovir Dipivoxil, Telbivudine, and Entecavir in Treating Nucleoside Analogues Naïve for HBeAg-Negative Hepatitis B with Medium Hepatitis B Virus (HBV) DNA Levels

et al. 2017

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BackgroundThe antiviral effect of HBV in different nucleos (t) ide analogues is still not well known. This study was conducted to compare the effectiveness of lamivudine (LMV), adefovir dipivoxil (ADV), telbivudine (LdT), and entecavir (ETV) monotherapy in chronic HBeAg-negative hepatitis B patients with medium load of HBV DNA.Material/MethodsThe effective data of 207 patients treated by LMV (n=43), ADV (n=57), LdT (n=54) or ETV (n=53) were collected and analyzed during 144-week follow-up by retrospective analysis.ResultsSerum HBV DNA levels were significantly lower in the ETV group 1.91±0.45 log10 IU/ml) than in the LdT group (2.09±0.62 log10 IU/ml), ADV group (2.26±0.73 log10 IU/ml), and LMV group (2.08±0.75 log10 IU/ml) at 12 weeks (P=0.0464). HBV DNA levels were maintained at lower levels in the ETV group compared to other 3 groups during follow-up (48 weeks, P<0.001; 96 weeks, P<0.001). Multivariate Cox regression analysis showed that LMV (P=0.001), ADV, (P<0.001), and LdT (P<0.001) were all negative predictors of HBV DNA-negative time, but ETV was not. Viral breakthrough occurred in 34.8% (15/43) of patients in the LMV group; 5.26% (3/57) in the ADV group, 7.4.0% (4/54) in the LdT group, and 0% (0/53) in the ETV group at the end of follow-up. No significant differences were found in mean ALT levels (all P>0.05) or in cumulative normalization rates (P=0.473).ConclusionsETV was more potent and faster for viral response and lower viral breakthrough in medium load of HBV DNA when compared to LMV, ADV, or LdT monotherapy in HBeAg-negative CHB.

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Section: Discussionsupporting

confidence: 60%

Comparing Efficacy of Lamivudine, Adefovir Dipivoxil, Telbivudine, and Entecavir in Treating Nucleoside Analogues Naïve for HBeAg-Negative Hepatitis B with Medium Hepatitis B Virus (HBV) DNA Levels

et al. 2017

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“…In this 3-year head-to-head study on patients with HBV-related compensated cirrhosis, the cumulative virological breakthrough rate of Etv monotherapy (9.8%) was lower than that of Lam + Adv (32.2%). In previous studies, after 48 weeks’ therapy with Etv alone or Lam + Adv in CHB patients, virological breakthrough rates were between 0 and 4.3% in HBeAg-positive patients,15,16 while no virological breakthrough was observed in HBeAg-negative patients 14. Similarly, in a real-world longitudinal observational study in China, Lam-based treatment was associated with higher probability of virological breakthrough (21.4%) compared to Etv (1.6%) after 52 weeks of therapy 17…”

Section: Discussionmentioning

confidence: 94%

<p>Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study</p>

Wu¹,

Zhou²,

Xie³

et al. 2019

IDR

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Background De novo combination of lamivudine (Lam) and adefovir (Adv) was not rarely used in clinical practice. However, head-to-head comparisons of entecavir (Etv) monotherapy with this combination in hepatitis B virus (HBV)-related compensated cirrhosis patients are unavailable. This study aimed to compare the efficacy and safety of Etv monotherapy with combination therapy in patients with HBV-related compensated liver cirrhosis. Methods Treatment-naïve patients with HBV-related compensated liver cirrhosis were recruited to receive either Etv monotherapy or a de novo combination of Lam and Adv. Data were collected at baseline and every 6 months thereafter. Results A total of 578 patients (485 in Etv group, 93 in combination group) were included. Baseline characteristics were comparable between the two groups. At the end of 1, 2, and 3 years, HBV DNA was undetectable in 82.7%, 96.2%, and 94.3% of patients in the Etv group and 88.9%, 81.7%, and 84.6% in the combination group, respectively (all P >0.05). The cumulative virological breakthrough rate at 1, 2, and 3 years was 2.7%, 6.7%, and 9.8% in the Etv group and 2.9%, 13.3%, and 32.2% in the combination group, respectively ( P =0.003). After propensity-score adjustment for age, sex, and baseline HBeAg, ALT, and total bilirubin, virological breakthrough was higher in the de novo combination of Lam and Adv (HR 2.83, 95% CI 1.37–5.86; P <0.01). The cumulative rate of liver-related events, including decompensation and hepatocellular carcinoma, at 1, 2, and 3 years was 2.9%, 4.2%, and 6.1% in the Etv group and 2.2%, 2.2%, and 6.7% in combination group, respectively ( P =0.83). Biochemical response and serological response were similar between the groups. Conclusion Etv treatment had less virological breakthrough and potentially higher HBV-DNA suppression than de novo combination of Lam and Adv during 3 years in treatment-naïve HBV-related compensated liver cirrhosis.

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Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

et al. 2020

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Nucleos(t)ide analogues (NAs) are the main drug category used in chronic hepatitis B (CHB) treatment. Despite the fact that NAs have a favourable safety profile, undesired adverse events (AEs) may occur during the treatment of CHB. Given the eminent number of patients currently receiving NAs, even a small risk of any of these toxicities can represent a major medical issue. The main objective of this review was to analyse information available on AEs associated with the use of NAs in published studies. We choose the following MesH terms for this systematic review: chronic hepatitis B, side effects and treatment. All articles published from 1 January 1990 up to 19 February 2018 in MEDLINE of PubMed, EMBASE, the Cochrane Library and LILACS databases were searched. A total of 120 articles were selected for analysis, comprising 6419 patients treated with lamivudine (LAM), 5947 with entecavir (ETV), 3566 with tenofovir disoproxil fumarate (TDF), 3096 with telbivudine (LdT), 1178 with adefovir dipivoxil (ADV) and 876 with tenofovir alafenamide (TAF). The most common AEs in all NAs assessed were abdominal pain/discomfort, nasopharyngitis/upper respiratory tract infections, fatigue, and headache. TAF displays the highest density of AEs per patient treated among NAs (1.14 AE/treated patient). In conclusion, treatment of CHB with NAs is safe, with a low incidence of AEs. Despite the general understanding TAF being safer than TDF, the number of patients treated with TAF still is too small in comparison to other NAs to consolidate an accurate safety profile. PROSPERO Registration No. CRD42018086471

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Combination lamivudine and adefovir versus entecavir for the treatment of naïve chronic hepatitis B patients: A pilot study

Cited by 5 publications

References 29 publications

Comparing Efficacy of Lamivudine, Adefovir Dipivoxil, Telbivudine, and Entecavir in Treating Nucleoside Analogues Naïve for HBeAg-Negative Hepatitis B with Medium Hepatitis B Virus (HBV) DNA Levels

Comparing Efficacy of Lamivudine, Adefovir Dipivoxil, Telbivudine, and Entecavir in Treating Nucleoside Analogues Naïve for HBeAg-Negative Hepatitis B with Medium Hepatitis B Virus (HBV) DNA Levels

<p>Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study</p>

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

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