The authors assessed the efficacy and antiviral resistance of 48-week clevudine therapy versus lamivudine in treatment of naive patients with HBeAg positive chronic hepatitis B. In this retrospective study, a total of 116 HBeAg positive patients, who received 30 mg of clevudine once daily (n=53) or 100 mg of lamivudine once daily (n=63) for 48 weeks, were included. At week 48, clevudine therapy produced a significantly greater mean reductions in serum HBV DNA levels from baseline than lamivudine therapy (-5.2 vs. -4.2 log(10)IU/mL; P=0.005). Furthermore, a significantly higher proportion of patients on clevudine achieved negative serum HBV DNA by PCR (<13 IU/mL) at week 48 (60.4% vs. 38.1%; P=0.025). The incidence of virologic breakthrough in the clevudine group was significantly lower than in the lamivudine group (9.4% vs. 25.4%; P=0.031). However, rates of alanine aminotransferase normalization and HBeAg loss or seroconversion were similar in the two groups (83.0% vs. 81.0%, 11.3% vs. 11.1%; P=0.813, 1.000, respectively). In conclusion, clevudine is more potent for viral suppression and lower for antiviral resistance at week 48 than lamivudine in treatment of naive patients with HBeAg positive chronic hepatitis B.
Adult ; Antiviral Agents/administration & dosage ; Arabinofuranosyluracil/administration & dosage/*analogs & derivatives ; Drug Resistance, Viral ; Female ; Hepatitis B e Antigens/*blood ; Hepatitis B, Chronic/diagnosis/*drug therapy/*immunology ; Humans ; Lamivudine/*administration & dosage ; Male ; Treatment Outcome

It is generally accepted that seroconversion of hepatitis B virus (HBV) surface antigen (HBsAg) to an antibody to HBsAg (anti-HBs) indicates clearance of HBV. Here we report a case of severe hepatitis that manifested during chemotherapy in a female patient with chronic lymphocytic leukemia (CLL) who had been initially seronegative for HBsAg and seropositive for anti-HBs. The patient received chlorambucil and prednisolone for the treatment of CLL. After 6 months the serum levels of aminotransferases were increased, and HBsAg and HBV DNA were present in serum. Lamivudine was administered immediately after confirming the HBV reactivation, which considerably improved jaundice and aminotransferase levels after 3 weeks. The patient was able to resume the chemotherapy whilst continuing lamivudine treatment. This case report highlights the need for physicians to be aware of the potential risk of HBV reactivation even in an HBsAg-negative person but with detectable anti-HBc and/or anti-HBs, underscoring the need for future studies that explore the role of antiviral prophylaxis in this setting.
Aged ; Antineoplastic Combined Chemotherapy Protocols/*therapeutic use ; Chlorambucil/*therapeutic use ; Female ; Hepatitis B/*diagnosis/virology ; Hepatitis B Antibodies/*blood/immunology ; Hepatitis B Surface Antigens/*blood/immunology ; Hepatitis B virus/isolation & purification/physiology ; Humans ; Leukemia, Lymphocytic, Chronic, B-Cell/complications/*drug therapy ; Prednisolone/*therapeutic use ; Virus Activation

<b>OBJECTIVEb>To investigate the immunoregulation mechanism of Bushen Recipe (BSR) in patients with chronic hepatitis B (CHB) of Gan-Shen yin-deficiency and lingering damp-heat syndrome (GSS).

<b>METHODSb>Thirty-five patients with positive HBV DNA and abnormal alanine transaminase (ALT) level were assigned to the treatment group (22 patients) and the control group (13 patients), they were treated with BSR and alpha-2b interferon for 6 months respectively. Blood levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL) and HBV DNA were measured before and after treatment. And the expressions of immune effector molecules of nature killer (NK) cell, including perforin (PF), granzyme B (GrB), granulysin (GNLY), tumor necrosis factor-alpha (TNF-alpha) and gamma-interferon (gamma-IFN), were detected using flow cytometry.

<b>RESULTSb>Levels of ALT and AST declined significantly in both groups after treatment (P < 0.05 or P < 0.01), showing insignificant difference between them. And the expressions (%) of PF and GNLY in the treatment group reduced significantly after treatment, from 69.62 +/- 27.58 to 34.86 +/- 31.60 for PF and from 64.54 +/- 25.96 to 25.72 +/- 24.98 for GNLY (both P < 0.05). In the treatment group and the control group, as compared with before treatment, the total scores of Chinese medicine symptoms were significantly declined after treatment (P < 0.01), and the total scores of Chinese medicine symtoms in the treatment group was significantly lower than that of the control group (P < 0.05). As compared with the total effective rate of Chinese medicine syndromes in the control group after treatment, that in the treatment group was significantly increased (P < 0.05).

<b>CONCLUSIONb>The mechanism of BSR in immuneregulating on patients with CHB of GSS is by way of declining the expressions of relative immune effector molecules to promote the recovery of the damaged liver.

Adjuvants, Immunologic ; therapeutic use ; Adolescent ; Adult ; Diagnosis, Differential ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hepatitis B, Chronic ; drug therapy ; immunology ; Humans ; Killer Cells, Natural ; immunology ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; Young Adult

<b>OBJECTIVEb>To explore the relation between the effect of Huashi Decoction (HD) and levels of activated and functional T lymphocyte subsets in chronic hepatitis B (CHB) patients of dampness syndrome (DS).

<b>METHODSb>Seventy CHB patients were nonrandomly assigned to two groups, the treated group (n = 45) treated by HD and the control group (n = 30) by nucleotide analogies. The clinical efficay was observed and levels of activated and functional T lymphocyte subsets were detected before and after treatment.

<b>RESULTSb>The peripheral blood levels of CD8+ CD28+ and CD4+ CD28+ T cells were significantly lower in CHB patients than those in the healthy subjects (P < 0.01), which were higher in the treated group after treatment compared with those before treatment (P < 0.05), while the CD8+ CD38+ T cell level was significantly higher in CHB patients than in the healthy subjects (P < 0.05), which was lower in the treated and the control groups after treatment than those before treatment respectively (P < 0.05). No significant difference was found in the markedly effective rate and total effective rate between the two groups (P > 0.05). The levels of CD8+ CD28+ and CD4+ CD28+ T cells increased and the CD8+ CD3+ and CD4+ CD25+ T cell level decreased obviously after treatment in those who acquired marked effectiveness (P < 0.05), while they changed insignificantly in those who did not acquire marked effectiveness (P > 0.05).

<b>CONCLUSIONb>HD is effective in regulating activated and functional T lymphocyte subsets in CHB patients with DS, which might be its mechanism of inhibiting virus replication and eliminating virus.

Adolescent ; Adult ; Diagnosis, Differential ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hepatitis B, Chronic ; drug therapy ; immunology ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; Syndrome ; T-Lymphocyte Subsets ; drug effects

<b>OBJECTIVEb>To study the effect of Yidu Recipe (YDR) in treating patients of chronic hepatitis B (CHB) with positive hepatitis B e-antigen (HBeAg) and its influence on the quantity and function of T-cell subsets.

<b>METHODSb>Fifty-seven CHB patients measured up the inclusive criteria were randomly assigned to the control group and the treated group, treated respectively by entecavir alone and entecavir + YDR for 6 months. Changes of alanine a minotransferase (ALT), aspartate a minotransferase (AST), HBV-DNA, HBV-M, interleukin-4 (IL-4) and Chinese medicine syndrome score, as well as amounts of natural killer (NK) T cell, gamma-interferon (gamma-IFN), Th1, Th2, Tc1 and Tc2 cells in peripheral blood (detected by flow cytometry) before and after treatment were observed. And the liver function normalization rate, negative inversion rates of HBV-DNA and HBeAg were estimated at terminal of the trial.

<b>RESULTSb>Seven cases were dropped out in the observation period. Compared with the control group, levels of ALT, AST, HBV-DNA and Chinese medicine syndrome score were lower after treatment (P < 0.05), and liver function normalization rate was higher in the treated group, while the difference between groups in negative inversion rates HBV-DNA and HBeAg were insignificant (P > 0.05). Amount of IFN-gamma increased, IL-4 reduced, and Tc1 cell raised after treatment, which led to the rise of Tcl/Tc2 ratio in both groups; while in the treated group, in addition to the above-mentioned changes, the Th1 cell was increased also, and thus to make elevation of Th1/Th2 ratio (P < 0.05).

<b>CONCLUSIONb>The efficacy of entecavir + YDR in treating HBeAg positive CHB patients is better than that of entecavir alone. YDR can effectively improve patients' liver function, inhibit HBV-DNA replication and improve clinical symptoms, its action may be realized by way of increasing the amount of NKT cells, inducing increase of IFN-gamma and decrease of IL-4 secretions, and regulating the balance between Th1/Th2 and Tc1/Tc2.

Adult ; Antiviral Agents ; therapeutic use ; Diagnosis, Differential ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Guanine ; analogs & derivatives ; therapeutic use ; Hepatitis B, Chronic ; drug therapy ; immunology ; Humans ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; T-Lymphocyte Subsets ; immunology ; Th1-Th2 Balance ; Yin Deficiency ; drug therapy ; immunology ; Young Adult

BACKGROUND/AIMS: The efficacy of tenofovir disoproxil fumarate (TDF) for the treatment of chronic hepatitis B (CHB) patients following prior treatment failure with multiple nucleos(t)ide analogues (NAs) is not well defined, especially in Asian populations. In this study we investigated the efficacy and safety of TDF rescue therapy in CHB patients after multiple NA treatment failure. METHODS: The study retrospectively analyzed 52 CHB patients who experienced failure with two or more NAs and who were switched to regimens containing TDF. The efficacy and safety assessments included hepatitis B virus (HBV) DNA undetectability, hepatitis B envelop antigen (HBeAg) seroclearance, alanine transaminase (ALT) normalization and changes in serum creatinine and phosphorus levels. RESULTS: The mean HBV DNA level at baseline was 5.4 +/- 1.76 log10 IU/mL. At a median duration of 34.5 months of TDF treatment, the cumulative probabilities of achieving complete virological response (CVR) were 25.0%, 51.8%, 74.2%, and 96.7% at 6, 12, 24, and 48 months, respectively. HBeAg seroclearance occurred in seven of 48 patients (14.6%). ALT levels were normalized in 27 of 31 patients (87.1%) with elevated ALT at baseline. Lower levels of HBV DNA at baseline were significantly associated with increased CVR rates (p < 0.001). However, CVR rates did not differ between TDF monotherapy or combination therapy with other NAs, and were not affected by mutations associated with resistance to NAs. No significant adverse events were observed. CONCLUSIONS: TDF is an efficient and safe rescue therapy for CHB patients after treatment failure with multiple NAs.
Adenine/adverse effects/*analogs & derivatives/therapeutic use ; Adult ; Aged ; Alanine Transaminase/blood ; Antiviral Agents/adverse effects/*therapeutic use ; Biological Markers/blood ; Creatinine/blood ; DNA, Viral/blood ; Drug Resistance, Viral/genetics ; Drug Substitution ; Female ; Genotype ; Hepatitis B e Antigens/blood ; Hepatitis B virus/*drug effects/genetics/immunology/pathogenicity ; Hepatitis B, Chronic/blood/diagnosis/*drug therapy ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Mutation ; Phosphorous Acids/adverse effects/*therapeutic use ; Phosphorus/blood ; Retrospective Studies ; Time Factors ; Treatment Failure ; Viral Load ; Young Adult

<b>OBJECTIVEb>To observe the effect of Spleen-invigorating Prescription (SIP) on dendritic cell function in patients with chronic hepatitis B.

<b>METHODSb>A total of 60 patients with chronic HBV of Pi-deficiency syndrome type were enrolled and randomized to 2 groups, 30 in each group. Patients in the control group were given intramuscular injection with human interferon alpha 1b, 3 times a week, while those in the treated group were given orally with SIP twice a day, the therapy lasted for 6 months. Dendritic cells (DCs) were isolated from peripheral blood and cultured, then the expression of surface markers, HLA-DR, CD86, CD80, CD40, CD14 and CD11c were detected before and after treatment by flow cytometry, and the function of DCs was also evaluated by mixed lymphocyte reaction (MLR) determination once before treatment and once after treatment.

<b>RESULTSb>The expressions of DCs' surface CD86, CD80, CD40 and CD11c in the treated group were higher (P < 0.05, P < 0.01) and the changes of stimulating index, IFN-gamma and IL-12 were superior in the treated group to those in the control group (P < 0.05).

<b>CONCLUSIONSb>SIP can significantly improve DC's function, so, one of mechanisms of SIP in improving clinical efficacy may be the regulation of immune function.

Adult ; Antiviral Agents ; therapeutic use ; B7-1 Antigen ; analysis ; B7-2 Antigen ; analysis ; Dendritic Cells ; cytology ; drug effects ; immunology ; Diagnosis, Differential ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Hepatitis B, Chronic ; drug therapy ; immunology ; Humans ; Interferon-alpha ; therapeutic use ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; Syndrome ; Yang Deficiency ; drug therapy ; Young Adult