New assays for quantitative determination of viral markers in management of chronic hepatitis B virus infection

Zoulim, Fabien; Mimms, Larry; Floreani, Marco; Pichoud, Christian; Chemin, Isabelle; Kay, Alan; Vitvitski, L.; Trépo, C.

doi:10.1128/jcm.30.5.1111-1119.1992

Cited by 31 publications

(5 citation statements)

References 36 publications

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“…Data from this study indicate that patients responding to IFN had a higher rate of HBsAg decline than LAM-treated patients. A decrease of serum HBsAg levels during IFN [25] or LAM treatment [17] has already been observed. However, no study has so far compared the rates of serum HBsAg decline between these two drugs.…”

Section: Discussionmentioning

confidence: 90%

Prediction of Treatment-Related HBsAg Loss in HBeAg-Negative Chronic Hepatitis B: A Clue from Serum HBsAg Levels

et al. 2007

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Background Quantification of HBsAg in serum may be of clinical importance in predicting HBsAg seroconversion and complete response to treatment. Methods Serum HBsAg was quantified by ADVIA Centaur® in 63 patients with HBeAg-negative chronic hepatitis B (CHBe-). A total of 42 had received interferon-α2b (IFN-α2b) (median 12.1 months; 19 sustained responders including 12 HBsAg-seroconvertors; 23 non-sustained responders) and 21 were on lamivudine (LAM) (median 33.0 months). Measurements were done at baseline, during and at the end of treatment, and during and at the end of follow-up. Results Baseline median [interquartile range (IQR)] HBsAg levels in all patients were 3,286 (1,602–7,458) IU/ml, not different between IFN- and LAM-treated ( P=0.139). IFN significantly depressed HBsAg in all patients except IFN non-responders, but HBsAg decline persisted only in sustained responders. Low pretreatment HBsAg level was the only significant prognostic variable of HBsAg seroconversion by multivariate analysis. LAM treatment also suppressed HBsAg levels but at a significantly slower rate compared with IFN ( P=0.022). The median (IQR) estimated time to HBsAg undetectability (ETU-HBsAg), derived from best curve fitting, was 127 (87.6–263.5) months for LAM virological responders and 65.3 (36.3–95.0) months for IFN sustained responders ( P=0.002). In 12 HBsAg seroconvertors, ETU-HBsAg was similar to the real time of HBsAg loss ( P=0.525) and seroconversion (0.056). Conclusions In CHBe-, IFN induces a sharper decrease in serum HBsAg compared with LAM and low pretreatment levels are significantly associated with HBsAg seroconversion. Serial HBsAg measurements may be useful for prediction of HBsAg loss and our data suggest that to achieve this, 5.4 years of sustained response to IFN or 10.6 years of effective LAM therapy are probably needed.

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Section: Discussionmentioning

confidence: 90%

Prediction of Treatment-Related HBsAg Loss in HBeAg-Negative Chronic Hepatitis B: A Clue from Serum HBsAg Levels

et al. 2007

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“…One method, HBs Ag quantification, is considered to be strongly related to the total amount of HBV DNA in the body, including HBV DNA in hepatocytes. [26][27][28][29] In particular, qHBs Ag is known to be a predictor of the antiviral treatment response in patients receiving the PEG-IFN treatment. [30][31][32] Although the qHBs Ag level could not predict the treatment response for patients treated with NAs unlike the PEG-IFN treatment, [18,19,33,34,35] the qHBs Ag level is expected to have clinical implications related to the prognosis of CHB patients because it reflects the total amount transcribed from the integrated DNA and ccc DNA.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, studies on the serological markers that can be used to monitor continuously the natural history, assess the treatment response, and predict the risk of liver-related complications in CHB patients are conducted alongside treatment. One method, HBs Ag quantification, is considered to be strongly related to the total amount of HBV DNA in the body, including HBV DNA in hepatocytes [26–29] . In particular, qHBs Ag is known to be a predictor of the antiviral treatment response in patients receiving the PEG-IFN treatment [30–32] .…”

Section: Discussionmentioning

confidence: 99%

Association between HBs Ag quantification and the risk of hepatocellular carcinoma in patients treated with tenofovir disoproxil fumarate or entecavir

Lim

Suh

et al. 2021

Medicine

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This study evaluated the clinical implications of hepatitis B surface antigen quantification (qHBs Ag) in chronic hepatitis B (CHB) patients treated with entecavir (ETV) or tenofovir disoproxil fumarate (TDF) and identified the association between qHBs Ag and the risk of hepatocellular carcinoma (HCC) in these patients. Between January 2007 and December 2018, the qHBs Ag and clinical data of 183 CHB patients who initially received ETV (n = 45, 24.6%) or TDF (n = 138, 75.4%) were analyzed. The mean follow-up period of the 183 CHB patients was 45.3 months, of which 59 (32.2%) patients showed a reduction in qHBs Ag by >50% after 1 year of antiviral treatment (ETV or TDF). The HCC development ( P = .179) or qHBs Ag reduction ( P = .524) were similar in the ETV and TDF groups. Patients with a ≥50% decrease in qHBs Ag had a significantly lower incidence of HCC or decompensated cirrhosis complications ( P = .005). Multivariate analysis showed that a >50% reduction of qHBs Ag (hazard ratio 0.085, P = .018) and the presence of cirrhosis (hazard ratio 3.32, P = .016) were independent factors predicting the development of HCC. Patients whose qHBs Ag value decreased >50% at 1 year after antiviral treatment for CHB showed a significant decrease in HCC or decompensated cirrhosis events. A reduction in qHBs Ag could be used as a predictive factor of HCC development or critical complications in CHB patients treated with TDF or ETV.

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“…In conclusion, monthly monitoring of HBV-DNA, ALT and IgM anti-HBc by quantitative assays appears to be an effective, relatively inexpensive and reliable method to study patients with chronic HBV infection. Sporadic, single determinations of these parameters provide "instantaneous snapshots" of the disease but do not reveal the series of dynamic events responsible for hepatitis B exacerbations which condition the natural history of chronic HBV infection (34, 35). This method can be proposed as a useful guide for clinical and therapeutic decision making in single patients with chronic hepatitis B.…”

Section: Discussionmentioning

confidence: 99%

Fluctuations in viremia, aminotransferases and IgM antibody to hepatitis B core antigen in chronic hepatitis B patients with disease exacerbations

Mels

Bellati

Leandro

et al. 1994

Liver

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We studied the relationships between the serum levels of viremia, aminotransferases and IgM anti‐HBc, measured by monthly quantitative assays, in 52 untreated chronic hepatitis B patients (41 anti‐HBe+, 11 HBeAg+) followed up for 12–20 months. Forty hepatitis exacerbations were observed in 17/41 anti‐HBe+ (41.5%) and in 6/11 HBeAg+ patients (54.5%) (p = NS); all but one were clinically asymptomatic. We analyzed the fluctuations in the serum levels of the three parameters before, during and after the hepatitis exacerbations and found this chronological sequence of events in 96.2% of them: HBV‐DNA increase→ALT flare→IgM anti‐HBc increase. These results suggest that both antiviral immune reactions and ALT flares were triggered by quantitative variations in viremia. HBV‐DNA baseline levels before flares were lower in anti‐HBe+ (3.9±1.2 pg/ml) than in HBeAg+ patients (35.3±5.4 pg/ml) (p<0.0001) and there was an inverse correlation between basal values and viremia level increases at the time of disease exacerbations (p< 0.001). This suggests that for a hepatitis exacerbation to occur, low basal viremia needed to increase markedly, while moderate increases in HBV‐DNA serum levels were sufficient to trigger ALT flares in patients with elevated basal viremia. In conclusion, asymptomatic hepatitis B exacerbations are frequent in the natural history of chronic HBV infection, and monthly monitoring of HBV‐DNA, ALT and IgM anti‐HBc appears to be a suitable method to evaluate their frequencies and entities. This method can be a helpful guide for clinical and therapeutic decision‐making in the single patient with chronic hepatitis B.

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New assays for quantitative determination of viral markers in management of chronic hepatitis B virus infection

Cited by 31 publications

References 36 publications

Prediction of Treatment-Related HBsAg Loss in HBeAg-Negative Chronic Hepatitis B: A Clue from Serum HBsAg Levels

Prediction of Treatment-Related HBsAg Loss in HBeAg-Negative Chronic Hepatitis B: A Clue from Serum HBsAg Levels

Association between HBs Ag quantification and the risk of hepatocellular carcinoma in patients treated with tenofovir disoproxil fumarate or entecavir

Fluctuations in viremia, aminotransferases and IgM antibody to hepatitis B core antigen in chronic hepatitis B patients with disease exacerbations

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