Reuters Health Information (2005-02-25): Tenofovir an option in HIV/HBV coinfection
Tenofovir an option in HIV/HBV coinfection
Last Updated: 2005-02-25 15:41:12 -0400 (Reuters Health)
BOSTON (Reuters Health) - In a head-to-head clinical
trial comparing the efficacy of tenofovir with adefovir, researchers
found that tenofovir safely and effectively lowers hepatitis B virus
levels in patients who are also infected with HIV.
"This is the first randomized, controlled study to show that
tenofovir is an option in the treatment of patients co-infected with
HIV and HBV," lead investigator Dr. Marion Peters said. "Twenty percent
of HIV-infected subjects have hepatitis B," she explained, "so
coinfection is a major issue, both in this country and worldwide," she
told participants of the 12th Annual Retroviral Conference on Thursday.
Dr. Peters of San Francisco and other investigators in AIDS Clinical
Trial Group A5127 enrolled 52 co-infected patients who were on stable
combination antiretroviral therapy. At baseline 75% of the subjects had
HIV RNA below 50 copies/mL and 98% had compensated liver disease.
The subjects were randomized to tenofovir 300 mg plus placebo or
adefovir 10 mg plus placebo daily for up to 96 weeks, and underwent
laboratory evaluations weekly. Eighty percent of the subjects were
Tenofovir has shown "activity against both wild-type and
lamivudine-resistant HBV," Dr. Peters explained. Tenofovir is approved
for treating HIV infection, but not HBV infection. Adefovir is
currently licensed for HBV infection.
"The study was stopped after 52 of 60 subjects had accrued because
we met our primary endpoint, showing that tenofovir was not inferior to
adefovir and in fact decreased HBV DNA more than adefovir," she said.
At 48 weeks, the mean log10 time-weighted average change in HBV DNA
from baseline was -4.4 in the tenofovir group and -3.21 in the adefovir
Laboratory abnormalities were seen in 18 patients in both arms, but
there were no adverse events. Although there were two deaths in each
group, they were not related to the drugs, she said. No renal
toxicities were detected.
"In summary, tenofovir is an option for the treatment of co-infected
subjects. Although there are uncontrolled data published, this is the
first randomized, controlled study showing this effect. So we have now
added an option for these patients," she concluded.