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Ira S. Goldman, MD;
John L. Gollan, MD, PhD; Kris V. Kowdley, MD; Paul Martin, MD; Marion
G. Peters, MD |
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HEPATOLOGY WATCH® |
APRIL 2003
HEPATITIS
B VIRUS (HBV )
Adefovir
dipivoxil therapy. Adefovir dipivoxil is a nucleotide analogue that has
potent antiviral activity against HBV.
Stephanos Hadziyannis et al. from the Adefovir Dipivoxil 438 Study Group
conducted a double-blind study in which 185 patients with HBeAg-negative
chronic hepatitis B were randomized in a 2:1 ratio to receive 10 mg of adefovir
or placebo daily for 48 weeks. At week 48,
64% of adefovir-treated patients versus 33% of patients in the placebo group
had improvement of histological liver abnormalities as measured by the Knodell
necroinflammatory score, and ALT levels normalized in 72% versus 29% of
patients, respectively. Moreover, HBV
DNA levels became undetectable in 51% and 0% of patients treated with adefovir
and placebo, respectively. Patrick
Marcellin et al. from the Adefovir Dipivoxil 437 Study Group performed a second
double-blind study in which 515 patients with HBeAg-positive chronic hepatitis
B were equally randomized to receive 10 mg of adefovir, 30 mg of adefovir, or
placebo daily for 48 weeks. At week 48,
significantly greater percentages of 10 mg or 30 mg adefovir-treated patients
compared to placebo patients had improvement of histological liver
abnormalities (53%, 59%, and 25%, respectively), normalization of serum ALT
levels (48%, 55%, and 16%, respectively), HBeAg seroconversion (12%, 14%, and
6%, respectively), and undetectable serum levels of HBV DNA (21%, 39%, and 0%,
respectively). No HBV polymerase
mutations associated with resistance to adefovir were identified in either
study. (Hadziyannis SJ, et al. N Engl J
Med 2003;348:800-807; Marcellin P, et al. N Engl J Med 2003;348:808-816)
HEPATITIS
C VIRUS (HCV)
Coinfection
with HIV. Mark Sulkowski and David Thomas conducted a
literature review of published studies of HCV infection in HIV-infected
patients. The studies show that
infection with HIV adversely affects the outcome of HCV, and medical management
is complicated by immune suppression, potential drug interactions and
toxicities, and other concomitant liver diseases. There are little data published concerning
treatment of HCV in coinfected patients with currently available agents. The authors conclude that large prospective
studies to determine optimal therapy are needed. (Sulkowski MS, Thomas DL. Ann Intern Med 2003;138:197-207)
HCV infection
after liver retransplantation. Marina Berenguer et al. from
ASCITES
Transjugular
intrahepatic portosystemic shunt (TIPS).
Arun Sanyal and others of
The North American Study for the Treatment of Refractory Ascites performed a
multicenter, prospective trial in which 109 patients with refractory ascites
were randomized to receive either medical therapy alone (sodium restriction,
diuretics, and total paracenteses) or medical therapy plus TIPS. Although medical therapy plus TIPS more
successfully prevented recurrent ascites than medical therapy alone,
transplant-free and overall survival rates were similar in the 2 treatment
groups. Moreover, the incidence of
moderate to severe encephalopathy was greater in TIPS-treated patients, and
there was no difference in the number of patients who developed disease-related
complications between the 2 groups.
These findings demonstrated that TIPS therapy was not associated with
improvements in survival, hospitalization rates, or quality of life. (Sanyal AJ, et al. Gastroenterology 2003;124:634-641)
LIVER
TRANSPLANTATION
Model for
End-Stage Liver Disease (MELD). The MELD score, based on serum creatinine, serum total
bilirubin, and INR, has been used to predict mortality in patients with
cirrhosis. Russell Wiesner and
colleagues prospectively applied the MELD score to estimate the 3-month
mortality of 3,437 adult liver transplant candidates listed with UNOS at status
2A or 2B. Among these candidates, 412
(12%) patients died within a 3-month follow-up period. Patients having a MELD score <9 had a
3-month mortality rate of 1.9% while those with a MELD score ³40 had a 3-month mortality rate of 71.3%. The area under the receiver operating characteristic
curve, with 3-month mortality as the endpoint, was significantly greater for
the MELD score compared to the Child-Turcotte-Pugh score (0.83 vs. 0.76). Furthermore, in a retrospective cohort study
of 760 patients on a liver transplant waiting list, Robert Merion et al. at the
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