Serum levels of hyaluronic acid, collagen N and laminin decreased markedly after treatment in both groups (P < 0.05). Hepatic histopathological examination showed that the total effective rate of impovement in activity of inflammation-necrosis and fibrosis was 80.0% and 70.0% in group A, 57.8% and 75.6% in group B, respectively, the combined treatment showed a better effect in improving the activity of inflammation-necrosis than QC alone (P < 0.05), but with no significant difference to the latter in improving fibrosis.
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This study addresses the dynamic of viral load rebound and immune system changes in a cohort of eight consecutive HIV-1-infected patients in very early stages [all the patients were taking highly active antiretroviral therapy (HAART} and were recruited in the coordinating center from a larger study] who decided to discontinue HAART after 1 year of treatment and effective virologic response. The safety of this procedure and the outcome with reintroduction of the same treatment was also investigated.
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Systematic review of initial ART studies (64 randomized, 15 cohort). Group-based analysis was by weighted, forward, stepwise, linear regression.
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One or more mutations associated with primary resistance to NA were seen in 10 antiretroviral-naive (13.3%) patients in 1993 and in nine (12%) in 1997. In all but two cases, they were associated with ZDV resistance. In contrast, all but six (96%) of the antiretroviral-experienced subjects harboured drug-resistant mutant viruses. The codon 184 mutation (associated with resistance to 3TC) was detected in 92% of patients treated with 3TC, but also in 18% of those treated with only ddI or ddC. The codon 215 mutation was found in 67.3% of patients who had been exposed to ZDV; the codon 69 mutation was found in 15% of patients treated with ddC; and the codon 74 mutation was found in only 7.2% of patients treated with ddI. Finally, the codon 151 multidrug resistant mutation was found in four (2.7%) of 150 patients with a long-term exposure to NA.
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We identified 139 Caucasian antiretroviral-naive male patients who started zidovudine/ lamivudine-based cART that was virologically successful over a 2 year period. Ninety-seven were randomly chosen and plasma hormone determinations of free testosterone (fT) and luteinizing hormone (LH) at baseline and after 2 years of cART were evaluated.
To describe a case of significant CD4+ cell decline despite complete viral suppression in an HIV-positive patient receiving didanosine and valganciclovir.
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Anti-viral therapy using lamivudine and thymosin alpha1 postoperatively may suppress the HBV reaction, delay the recurrence and prolong the survival for patients with HCC with coexisting active hepatitis B.
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Retrospective patient-level data econometric analysis.
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HIV-infected patients with active tuberculosis, receiving rifampicin > 1 month, were randomized to receive stavudine and lamivudine plus efavirenz 600 or 800 mg daily. Plasma efavirenz levels were measured (at 12 h after dosing and on day 14) by high-performance liquid chromatography. Plasma HIV RNA was assessed at 16 and 24 weeks after antiretroviral therapy.
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The aim of this study was to evaluate the efficacy of lamivudine therapy in elderly patients with chronic HBV infection.
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This study shows that the RT KKK nucleotide template in subtype C viruses can lead to the spurious detection of K65R by highly sensitive PCR-dependent sequencing techniques. However, the study is also consistent with the subtype C nucleotide template being inherently responsible for increased polymerization-induced K65R mutations in vivo.
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The rtA181T/sW172* variant has a secretory defect and exerts a dominant negative effect on wild-type HBV virion secretion. The selection of rtA181T/sW172* reduced the typical extent of virological breakthrough, resulting in a missed diagnosis of drug resistance if viral load was used as the only criterion for drug failure, necessitating HBV polymerase chain reaction sequencing or other genotypic methods to diagnose antiviral drug resistance in these cases.
CD8+ T lymphocytes may mediate important host responses to human immunodeficiency virus (HIV) infection by human leukocyte antigen (HLA)-restricted cytotoxicity and production of soluble HIV suppressor factors. CD8+ lymphocytes are also important for the suppression of many latent pathogens responsible for opportunistic disease in HIV-infected patients. There has been no systematic analysis of the responses of CD8+ lymphocyte counts to antiretroviral therapy. We compared CD8+ lymphocyte responses in seven trials of nucleoside or non-nucleoside analog reverse transcriptase inhibitors and in two trials of ritonavir, a HIV protease inhibitor. Nucleoside analog and non-nucleoside analog reverse transcriptase inhibitor monotherapy resulted in no substantial changes in CD8+ counts relative to baseline or placebo. Combination nucleoside analog therapy resulted in variable peak responses (-145 to +240 cells/mm3), which remained significantly above baseline for 0 to 12 weeks. In contrast, ritonavir monotherapy caused a peak increase of 892 CD8+ cells/mm3, which remained significantly above baseline for 32 weeks. There was a significant correlation (Rs 0.61, p = 0.01) between the peak CD4+ cell and CD8+ responses to each therapy, but no significant correlation between the peak viral load responses and peak CD8+ cell responses. These findings suggest that the greater CD8+ response seen with ritonavir may be due to its specific inhibition of HIV protease and also that the CD8+ response is dependent on new CD4+ cell production. The CD8+ lymphocyte proliferation observed with protease inhibitor therapy could result in improved suppression of HIV replication by the immune system and should be confirmed in a prospective trial comparing protease inhibitors with both nucleoside and non-nucleoside analog therapies.
Virological breakthrough was observed in both patients. Patient I acquired sustained virological response after switching to ETV rescue therapy, whereas Patient II suffered from virological breakthrough after 72 weeks of ETV therapy. Each virological breakthrough was accompanied with the replacement of previous drug susceptible dominant quasispecies with a drug resistant variant, indicating a close correlation between quasispecies composition and drug susceptibility. The rtL180M+S202G+M204V triple mutant, which was most likely a descendant of the LAM resistant rtL180M+M204V variant, was closely correlated with ETV resistant in Patient II.
Treatment with ZDV/3TC/LPV/r versus NVP/LPV/r differentially affects glucose and lipid metabolism. The ZDV/3TC/LPV/r regimen induced peripheral insulin resistance, a transient increase in basal lipolysis and a transient decrease in insulin-mediated inhibition of lipolysis, whereas hepatic insulin sensitivity improved with the NVP/LPV/r regimen.
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Lipoatrophy in HIV patients can result from prolonged exposure to thymidine analogues. Mitochondrial toxicity leading to dysregulated adipogenesis and increased cell death has been proposed as a leading factor in the etiology of peripheral fat loss. We hypothesized that thymidine analogues interfere with autophagy, a lysosomal degradation pathway, which is important for mitochondrial quality control, cellular survival, and adipogenesis. We assessed the effects of zidovudine (AZT), stavudine (d4T), and lamivudine (3TC) on autophagy in eukaryotic cells and adipocytes (3T3-F442A) by fluorescence microscopy and flow cytometry. The effects were compared to interventions with established genetic and pharmacological inhibitors of autophagy and correlated to assessments of cell viability, proliferation, and differentiation. AZT and d4T, but not 3TC, inhibited both constitutive and induced autophagic activity in adipocytes. This inhibition was associated with accumulation of dysfunctional mitochondria, increased reactive oxygen species (ROS) production, increased apoptosis, decreased proliferation, and impaired adipogenic conversion. Autophagy inhibition was dose and time dependent and detectable at therapeutic drug concentrations. Similar phenotypic changes were obtained when genetic or pharmacological inhibition of autophagy was employed. Our data suggest that thymidine analogues disturb adipocyte function through inhibition of autophagy. This novel mechanism potentially contributes to peripheral fat loss in HIV-infected patients.
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Reactivation of chronic hepatitis B virus (HBV) infection is a major cause of morbidity and mortality after renal transplantation. Although lamivudine is an effective treatment for chronic hepatitis B, the development of drug resistance due to mutations in the tyrosine-methionine-aspartate-aspartate (YMDD) motif is a major concern, especially in immunosuppressed patients who require prolonged therapy. Treatment with famciclovir has not been effective in the majority of patients who developed lamivudine resistance due to methionine-to-valine mutation at position 550, because this mutation has been uniformly associated with leucine-to-methionine mutation at position 526, a mutation that is associated with resistance to famciclovir. We describe a renal transplant recipient with an uncommon lamivudine-resistant HBV variant, in which methionine-to-valine/isoleucine mutation at position 550 was associated with wild-type sequence at position 526. The severe hepatitic flare consequent to the lamivudine resistance in this patient was successfully treated with famciclovir, indicating that both M550V and M550I mutants with preserved wild-type sequence at position 526 of HBV reverse transcriptase are susceptible to famciclovir. Our experience shows that famciclovir can be useful in selected patients with otherwise potentially fatal hepatitic flares related to lamivudine resistance, and that analysis of mutations in the HBV variant can be helpful in the choice of antiviral therapy.
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We reported a 23 years old male with chronic hepatitis C virus infection, discontinued from pegylated interferon/ribavirin combination therapy due to a lack of early virological response. He has developed activation of occult hepatitis B virus that was successfully treated by a one year of lamivudine therapy.
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Coinfection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) is associated with considerable liver disease morbidity and mortality. Emerging HIV epidemics in areas of high HBV endemicity such as Asia are expanding the population with HIV/HBV coinfection. Limited randomized trial data exist to support current guidelines for HBV combination therapy in HIV/HBV coinfection. The objective of this prospective randomized clinical trial was to compare the strategy of HBV monotherapy with lamivudine (LAM) or tenofovir disoproxil fumarate (TDF) versus HBV combination therapy with LAM/TDF in antiretroviral-naïve HIV/HBV-coinfected subjects in Thailand. Thirty-six HIV/HBV-coinfected subjects initiating highly active antiretroviral therapy (HAART) were randomized to either LAM (arm 1), TDF (arm 2), or LAM/TDF (arm 3) as HBV-active drugs within HAART. At week 48, time-weighted area under the curve analysis revealed that the median HBV DNA reduction from baseline was 4.07 log(10) c/mL in arm 1, 4.57 log(10) c/mL in arm 2, and 4.73 log(10) c/mL in arm 3 (P = 0.70). HBV DNA suppressed to <3 log(10) c/mL in 46% in arm 1, 92% in arm 2, and 91% in arm 3 (P = 0.013, intent-to-treat analysis). HBV-resistant changes were detected in two subjects, both in arm 1. Hepatitis B e antigen (HBeAg) loss was observed in 33% of HBeAg-positive subjects, and 8% experienced hepatitis B surface antigen loss. Hepatic flare was observed in 25% of subjects.
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Finite treatment of HBeAg-negative chronic hepatitis B (CHB) with nucleos(t)ide analogs (NAs) is important in resource limited countries. Outcome of treatment discontinuation in patients on long-term lamivudine (LVD) was assessed in a single center observational pilot study in the current study.
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Fifty-four HIV-infected children (ages 3.1 to 18.9 years) were enrolled. The indinavir free-base suspension was less bioavailable than the dry-filled capsule formulation, and therapy was changed to capsules in all children. Hematuria was the most common side effect, occurring in 7 (13%) children, and associated with nephrolithiasis in 1 patient. The combination of indinavir, lamivudine, and zidovudine was well tolerated. The median CD4 cell count increased after 2 weeks of indinavir monotherapy by 64 cells/mm3, and this was sustained at all dose levels. Plasma ribonucleic acid levels decreased rapidly in a dose-dependent way, but increased toward baseline after a few weeks of indinavir monotherapy.
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Prevalence of lipoatrophy varied from 7% to 24%, according to the definition. After adjustment for gender, age, treatment duration and CD4(+) T-cell count, the risk of lipoatrophy in the d4T(30) group was lower than in the d4T(30/40) group (odds ratio [OR] 0.3, 95% confidence interval [CI] 0.1-0.8 with the large definition and OR 0.2, 95% CI 0.0-0.8 with the strict definition) and was comparable to that of the AZT group (OR 1.0, 95% CI 0.2-4.6 and OR 1.0, 95% CI 0.4-2.2 with the large and strict definitions, respectively). The risk was significantly higher in the d4T(30/40) group compared with the AZT group (OR 2.9, 95% CI 1.3-6.4 with the large definition and OR 5.5, 95% CI 1.3-23.5 with the strict definition).
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At baseline, most patients had a normal neutrophil count and 80% of them were already receiving cotrimoxazole. An unexpectedly high rate of grade 3-4 neutropenia occurred shortly after introduction of AZT. Almost all of the persistent severe neutropenia disappeared after cotrimoxazole was stopped. This suggests an accentuated drug interaction between the two drugs in these sub-Saharan African individuals. Grade 3-4 anaemia was much less frequent, but remained the first cause of AZT discontinuation.
The patients enrolled were randomized into three groups (i.v group, i.m group and domino group). Under the combined utilization with Lamivudine, HBIG was given in different ways during anhepatic phase and the postoperative six days. The physical examination was done, the serum conversion rate of HBsAg was studied, the serum level of HBsAb titer, WBC, PLT, AST, GGT, TBIL, DBIL, CR, PT and PTA were tested daily within the postoperative seven days. The preoperative body weight, serum HBsAg and HBeAg titer were analyzed with the intravenous loading dosage of HBIG by multiple-factor linear regression (Stepwise).
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To investigate the histological changes in liver biopsy tissues taken from chronic hepatitis B patients with HBsAg and HBeAg positive and ALT abnormal after lamivudine therapy for one year.
The multidisciplinary consultation and patient education should enable an appropriate management of diabetes in HIV infected patients.
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To evaluate survival according to use of different nucleoside drugs in a routine clinical setting, we studied a large group of zidovudine-treated patients seen in clinics across Europe. A total of 3128 subjects was recruited to the observational, prospective EuroSIDA study in May 1994. These were consecutive patients (up to a predefined limit) seen at outpatient clinics in 37 centers from 16 European countries and followed at 6-month intervals by use of standardized forms completed by clinicians at the respective centers. This report concerns 2367 subjects who began antiretroviral therapy with a regime that included zidovudine either before study entry or during the course of follow-up. Cox proportional hazards models were fitted, with use of other antiretroviral drugs, CD4 count, and date of development of AIDS fitted as time-dependent covariates. Survival times from start of therapy were left truncated at study entry to avoid survival bias. In addition to zidovudine, antiretroviral drugs used included didanosine (ddI) (n = 1119; median 1.6 years after starting zidovudine), dideoxycytidine (ddC) (n = 592; median 1.9 years after starting zidovudine), stavudine (d4T) (n = 241; median 2.9 years after starting zidovudine) and lamivudine (3TC) (n = 33 ; median 2.7 years after starting zidovudine). Of the 2367 patients, 613 died during follow-up. Overall, risk of death was reduced in those zidovudine-treated patients who began at least one other nucleoside analogue drug with or after taking zidovudine (relative hazard [RH], 0.61; 95% confidence interval [CI], 0.51-0.72, adjusting for CD4 count, development of AIDS, and age). Fitting each drug separately, there was a larger association with reduced mortality for starting 3TC (RH, 0.41; 95% CI, 0.28-0.62) than for starting ddl (RH, 0.79; 95% CI, 0.67-0.93), ddC (RH, 0.74; 95% CI, 0.59-0.92) or d4T (RH, 0.67; 95% CI, 0.49-0.91). These results suggest that the beneficial effect of nucleoside combination therapy identified in controlled trials can be seen in routine clinical practice.
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Transplantation of hearts from donors with hepatitis-B core antibodies is associated with a small viral-transmission risk, with or without post-transplant, anti-viral prophylaxis. Use of these donor hearts should be considered safe and may help to augment the available donor pool.
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A total of 120 naïve patients with HBV-related decompensated cirrhosis participated in this study. Sixty patients were treated with combined LAM and ADV therapy (LAM + ADV group), while the other 60 were treated with ETV monotherapy (ETV group) for two years. Tests for liver and kidney function, alpha-fetoprotein, HBV serum markers, HBV DNA load, prothrombin time (PT), and ultrasonography or computed tomography scan of the liver were performed every 1 to 3 mo. Repeated measure ANOVA and the χ(2) test were performed to compare the efficacy, side effects, and the cumulative survival rates at 48 and 96 wk.