恩替卡韦用于HBV/HIV感染病人的抗HBV治疗获得依据（2005.2.25）

zasxz

CLINICAL CARE OPTIONS FOR HEPATITIS
http://clinicaloptions.com/hep/news/news_CROI2005_5.asp


Entecavir gains ground as anti-HBV option in HIV-coinfected patients

By Mark Mascolini

February 25, 2005 - Entecavir, an antiviral proven superior to lamivudine in
individuals infected only with hepatitis B virus (HBV), lowered HBV viral
load in people coinfected with HBV and HIV, according to new research. One
third of study participants taking entecavir reached a normal alanine
aminotransferase (ALT) level in 24 weeks, reported Dr. Pessoa from Sao
Paulo's Emilio Ribas Infection Institute at the 12th Conference on
Retroviruses and Opportunistic Infections held in Boston, Massachusetts.

Unlike 3 anti-HBV drugs used in coinfected people-lamivudine, adefovir, and
tenofovir-entecavir has no activity against HIV and so does not promote
evolution of HIV-resistant virus. Research shows no interaction between
entecavir and these other 3 agents. Moreover, entecavir does not affect
liver enzymes involved in metabolizing protease inhibitors and nonnucleoside
reverse transcriptase inhibitors.

The international trial enrolled 68 HBV/HIV-coinfected people already taking
lamivudine. Researchers randomized 51 enrollees to 24 weeks ofentecavir (1
mg once daily) and 17 to take placebo, while continuing lamivudine. All
study participants had detectable HBV viremia, and 88% had 1 or more
lamivudine-related mutations.

The predominantly white and male study group began treatment with an average
HBV viral load just above 9 log10 copies/mL. After 24 weeks the mean HBV
viral load fell 3.66 log10 copies/mL with entecavir while rising 0.11 log10
copies/mL in the placebo group, a highly significant difference in an
on-treatment analysis (P < .0001).

Among individuals assigned to receive entecavir, 84% had an HBV viral load
below 400 copies/mL or at least a 2-log (100-fold) HBV viral load drop from
baseline after 24 weeks of treatment.

While 47% of patients taking entecavir reached an ALT level below 1.25 times
the upper limit of normal, only 17% taking placebo did so. ALT readings fell
below the upper limit of normal in 34% taking entecavir and 8% taking
placebo, a difference that approached statistical significance (P = .08).

Laboratory abnormalities proved equivalent with entecavir and placebo, and
only 1 person taking entecavir had serious complications: hepatic
encephalopathy and esophageal varices judged to be unrelated to treatment.

Entecavir had no effect on HIV-1 viral load or CD4+ cell count, which
averaged 2.15 log10 copies/mL and 508 cells/mm3 at study entry,
respectively.

Reference

Pessoa W, Gazzard B, Huang A, et al. Entecavir in HIV/HBV-co-infected
patients: safety and efficacy in a phase II study (ETV-038). Program and
abstract of the 12th Conference on Retroviruses and Opportunistic
Infections; February 22-25, 2005; Boston, Massachusetts. Abstract 123.

e0712

翻译过来呀,老大不能这样呀,我看不懂