Beneficial effects of lamivudine in hepatitis B virus-related decompensated cirrhosis

Kapoor, Dharmesh; Guptan, R. C.; Wakil, Salma M.; Kazim, Syed Naqui; Kaul, Rachna; Agarwal, Shilpa; Raisuddin, Sheikh; Hasnain, Seyed E.; Sarin, Shiv Kumar

doi:10.1016/s0168-8278(00)80372-4

Cited by 142 publications

(134 citation statements)

References 17 publications

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“…Consequently, the 2 groups may not be sufficiently matched to allow a fair comparison to be made of the treatment effect. Despite all these limitations, given our results and those of other recently published studies, [4][5][6][7][8] and the natural history of severely decompensated HBV-cirrhosis, it is difficult to justify a randomized controlled study comparing lamivudine versus placebo in these patients.…”

Section: Discussionmentioning

confidence: 67%

Lamivudine Treatment Is Beneficial in Patients With Severely Decompensated Cirrhosis and Actively Replicating Hepatitis B Infection Awaiting Liver Transplantation: A Comparative Study Using A Matched, Untreated Cohort

et al. 2001

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Uncontrolled studies have suggested a beneficial effect of lamivudine in patients with decompensated cirrhosis caused by replicating hepatitis B virus (HBV). We analyzed the outcome of lamivudine treatment in 23 consecutive patients with severely decompensated HBV-cirrhosis defined as a Child-Pugh-Turcotte (CPT) score of >10, and compared with a historical untreated control group of 23 patients matched for age, gender, and baseline CPT score. Significant clinical response, defined as a decrease in the CPT score by >3 points, was observed in 14 of 23 (60.9%) treated patients versus none of the controls (P < .0001). The median change in CPT scores was ؊3.0 (range, ؊6 to ؉3) in the treated group versus ؉1.0 in the controls (range, ؊1 to ؉2) (P ‫؍‬ .016). Orthotopic liver transplantation (OLT) was performed in 34.8% of treated patients (median, 3.5; range, 1-32 months), versus 73.9% of controls (median, 3.0; range, 1-14 months) (P ‫؍‬ .04). Excluding transplanted patients, there were no deaths in the treated group versus 6 deaths in the control group (P ‫؍‬ .009). Time to death or OLT was significantly longer in treated patients than in controls (P < .001). Two patients developed lamivudine resistance after 9 and 12 months, respectively. Our results suggest that lamivudine significantly improves hepatic function in over half of the patients with decompensated cirrhosis and replicating HBV, and may confer a survival advantage. However, the small sample size and the use of a retrospective control cohort preclude drawing definitive conclusions. Lamivudine, the (Ϫ) enantiomer of 3Ј-thiacytidine (Epivir), is a nucleoside analogue that inhibits DNA synthesis by terminating the nascent proviral DNA chain through interference with the reverse transcriptase activity of hepatitis B virus (HBV) DNA polymerase. Two large multicenter, placebo-controlled studies have shown lamivudine to be effective in suppression of HBV DNA and improving histology in immunocompetent patients with well-compensated liver disease caused by chronic HBV infection. 1,2 These 2 studies have reported that 16% to 17% of these patients achieved seroconversion from hepatitis B e antigen (HBeAg) to hepatitis B e antibody (HBeAb), 1,2 which is thought to be the most important marker for sustained virologic remission after discontinuation of lamivudine. 3 The use of lamivudine in patients with decompensated HBV-cirrhosis has been reported in several uncontrolled studies, 4-8 including a previous report from our center. 6 Although the efficacy of lamivudine in stabilizing liver function and improving Child-Pugh score has been suggested, 5-7 the impact of lamivudine on survival and need for orthotopic liver transplantation (OLT) has not been previously examined. The lack of an untreated control group in these studies also makes it difficult to exclude selection bias as an explanation for the observed benefits of lamivudine in patients with decompensated HBV-cirrhosis.We report here our experience using lamivudine in a selected group of patients with severely de...

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Section: Discussionmentioning

confidence: 67%

Lamivudine Treatment Is Beneficial in Patients With Severely Decompensated Cirrhosis and Actively Replicating Hepatitis B Infection Awaiting Liver Transplantation: A Comparative Study Using A Matched, Untreated Cohort

et al. 2001

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“…54 This study was conducted in patients with e antigen-negative disease in which immuneinduced HBeAg seroconversion is not an option; therefore, the benefit of therapy is from the direct antiviral effect of the drug. Indeed, a decrease in viral load through antiviral therapy has been associated with histologic improvement, 26,27,[55][56][57][58][59][60][61] increased survival of patients with decompensated liver disease from hepatitis B, [62][63][64][65][66][67][68][69][70] and improved clinical outcome in patients with HBV reactivation following chemotherapy. 50,52,[71][72][73][74][75][76][77][78][79][80][81] Our analyses are conservative in the following aspects.…”

mentioning

confidence: 99%

Evaluation of the Cost-Effectiveness of Entecavir Versus Lamivudine in Hepatitis BeAg-Positive Chronic Hepatitis B Patients

Yuan¹,

Iloeje²,

Hay³

et al. 2008

JMCP

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BACKGROUND: As new treatment options for chronic hepatitis B virus (HBV) become available, evaluations of cost-effectiveness become important. Entecavir is a deoxyguanine nucleoside analogue approved by the U.S. Food and Drug Administration in March 2005 for HBV infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alanine aminotransferase or aspartate aminotransferase) or histologically active disease. Entecavir has demonstrated greater suppression of viral replication compared with lamivudine, but also has a relatively higher drug acquisition cost in the United States.

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“…Furthermore, treatment with lamivudine is associated with histologic improvement not only in terms of necroinflammatory score but also in terms of fibrosis score after long-term treatment [24] . One advantage of lamivudine is that it can be used safely in patients with decompensated cirrhosis [3][4][5][6][7][8][9][10] . In contrast to IFN-α, lamivudine is well tolerated without any significant side effects even in patients with decompensated cirrhosis.…”

Section: Discussionmentioning

confidence: 99%

“…Lamivudine is effective for controlling chronic hepatitis B and currently recommended as the first line of treatment for chronic active hepatitis B [1,2] . Even for patients with decompensated liver cirrhosis, lamivudine improves liver function and extends transplantation free intervals [3][4][5][6][7][8][9][10] . Since more than 10% of patients with chronic HBV infection are estimated to develop liver cirrhosis and may eventually suffer from decompensated liver cirrhosis or hepatocellular carcinoma, the role of lamivudine in the treatment of advanced liver disease caused by chronic HBV infection is large [11][12][13][14] .…”

Section: Introductionmentioning

confidence: 99%

Fatal liver failure caused by reactivation of lamivudine-resistant hepatitis B virus: A case report

Suzuki

Yotsuyanagi²,

Okuse³

et al. 2007

WJG

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We present a case of fetal liver failure caused by the activation of lamivudine-resistant hepatitis B virus (HBV) nine months after lamivudine treatment. A 57-year old man visited our hospital for the treatment of decompensated chronic hepatitis B. Lamivudine was started in December 2001. Subsequently, serum HBV was negative for HBV DNA with seroconversion from HBeAg to anti-HBe and improvement of liver function. However, HBV DNA and HBeAg were again detected in September 2002. He was complicated by breakthrough hepatitis and admitted to our hospital in November for severely impaired liver function. Vidarabine treatment was started and serum HBV DNA and alanine aminotransferase (ALT) decreased transiently. However, after the start of α-interferon treatment, HBV DNA level increased and liver function deteriorated. He died 1 mo after admission. An analysis of amino acid sequences in the polymerase region revealed that rtM204I/V with rtL80I/V occurred at the time of viral breakthrough. After the start of antiviral treatment, rtL180M was detected in addition to rtM204I/V and rtL80I/V, and became predominant in the terminal stage of the disease. HBV clone with a high replication capacity may be produced by antiviral treatment leading to the worsening of liver function. Antiviral therapy for patients with breakthrough hepatitis in advanced liver disease should be carefully performed.

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Beneficial effects of lamivudine in hepatitis B virus-related decompensated cirrhosis

Cited by 142 publications

References 17 publications

Lamivudine Treatment Is Beneficial in Patients With Severely Decompensated Cirrhosis and Actively Replicating Hepatitis B Infection Awaiting Liver Transplantation: A Comparative Study Using A Matched, Untreated Cohort

Lamivudine Treatment Is Beneficial in Patients With Severely Decompensated Cirrhosis and Actively Replicating Hepatitis B Infection Awaiting Liver Transplantation: A Comparative Study Using A Matched, Untreated Cohort

Evaluation of the Cost-Effectiveness of Entecavir Versus Lamivudine in Hepatitis BeAg-Positive Chronic Hepatitis B Patients

Fatal liver failure caused by reactivation of lamivudine-resistant hepatitis B virus: A case report

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