maraviroc is associated with the regression of liver fibrosis in HIV-positive
patients co-infected with hepatitis C, a small randomised study presented to the Sixth International
AIDS Society conference (IAS 2011) in Rome shows.
Investigators from the
University of Brescia in Italy believe that the beneficial impact of maraviroc (Celsentri) was due to its inhibition of
None of the patients
were taking hepatitis C therapy and researchers believe that treatment with
maraviroc could provide an important option for patients who are unresponsive to
or ineligible for hepatitis C treatment.
A total of 59
co-infected patients were included in the open-label, proof-of-concept study.
All were taking stable
antiretroviral therapy consisting of ritonavir-boosted atazanavir (Reyataz) in combination with
FTC/tenofovir (Truvada) and had an
undetectable HIV viral load.
The patients were
randomised into treatment and controls arms.
Patients in the
treatment arm added maraviroc to their HIV therapy, whereas individuals in the
control arm continued to take their existing combination of drugs.
wished to see if therapy with maraviroc led to the improvement in liver
fibrosis stage. This was assessed by
measuring liver stiffness using FibroScan
at baseline and week 24.
There were no
significant differences at baseline between the two arms of the study. The
patients had an average age of 46 years, 88% were men, and their median CD4
cell count was 500 cells/mm3.
Nearly all (93%) were
infected with the harder-to-treat hepatitis C genotypes 1 and 4. Hepatitis C
viral load at the start of the study was 5.4 log10 copies/ml, and liver
function was also comparable between the two arms, as was liver stiffness at
After 24 weeks of
therapy, both HIV and hepatitis C parameters remained unchanged, and liver
stiffness stage remained unaltered in 75% of patients in the treatment arm and
two-thirds of patients in the control arm.
Any analysis of the
patients who experienced a change in their liver stiffness status showed
significant differences between the two study arms.
Patients treated with
maraviroc were significantly more likely than those in the control arm to have
had an improvement in liver stiffness.
The proportion of
patients in the control arm with stage 1, or mild, fibrosis fell from 57% at
baseline to 47% at week 24, and the proportion of patients with stage 4
fibrosis, or cirrhosis, doubled from 14 to 28%.
analysis showed that treatment with maraviroc was associated with a significant
improvement in liver stiffness compared to the control arm (p = 0.03).
to patients with liver stiffness indicative of cirrhosis showed a significant
improvement in the patients taking maraviroc, but a deterioration for patients
in the control arm (both p < 0.01). The
number of patients in the maraviroc arm with stage 1 fibrosis increased
from 35 to 44% as a reflection of a reduction in the proportion of those
with stage 4 fibrosis.
believe that their findings may open up an important new treatment option for
many co-infected patients.
“Patients who add maraviroc to the current HIV therapy seem to show a
decrease in liver stiffness after 24 weeks, particularly when LS at baseline
was higher,” said Dr Paola Nasta.