Sustained
Response to Pegylated Interferon plus Ribavirin in
HIV/HCV Coinfected Patients with Advanced Immune Suppression
By
Liz Highleyman
Numerous studies have shown that HIV positive people
tend to experience more rapid liver disease progression
and respond less well to interferon-based therapy
than HIV negative people with chronic hepatitis C
virus (HCV) infection.
Some
evidence indicates that HIV/HCV coinfected patients
with well-preserved immune function -- indicated by
a high CD4 T-cell count -- may fare nearly as well
as those with HCV monoinfection, but outcomes for
people with advanced immune suppression are not well
understood.
Spanish
researchers therefore conducted a study to assess
the safety and efficacy of hepatitis C treatment in
a clinical cohort of HIV/HCV coinfected individuals
with severe immunodeficiency. The analysis included
542 participants treated with pegylated
interferon plus ribavirin between June 2001 and
April 2007.
Outcomes
of interest were sustained virological response (SVR),
or continued undetectable HCV RNA 24 weeks after completion
of therapy, and emergence of AIDS-defining events
while undergoing hepatitis C therapy. SVR rates were
compared between patients with advanced immune suppression,
defined as a CD4 count <250 cells/mm3 at
baseline, and those with higher CD4 cell levels.
Results
 |
Patients
with <250 cells/mm3 were somewhat less
likely to achieve SVR than those with higher counts
(26% vs 39%, respectively), but the difference did
not reach statistical significance (P = 0.09). |
|
In
a nested case-control study of matched patients,
the corresponding sustained response rates were
26% vs 32%, respectively, and the difference was
further from statistical significance (P = 0.5).
|
|
In
a multivariate analysis, baseline CD4 cell count
was not a significant predictor of sustained treatment
response. |
|
Only
2 participants (5%) with a CD4 count <250
cells/mm3 developed AIDS-related opportunistic illnesses
during follow-up. |
|
Patients
with CD4 counts <250 cells/mm3 had a trend
toward greater likelihood of severe hematological
(blood cell) toxicities (41% vs 29%, respectively)
and interferon or ribavirin dose reductions (31%
vs 20%, respectively), but again these differences
were not significant (both P = 0.1). |
Based
on these findings, the investigators concluded, "The
efficacy of pegylated interferon plus ribavirin in HIV/HCV
coinfected patients with advanced immunosuppression
is substantial and not significantly different to that
observed in the overall coinfected population. HCV therapy
is generally safe in the population of coinfected patients
with advanced immunosuppression."
The
sustained response rates observed in this study were
considerably lower than those obtained in most studies
of HCV monoinfected patients, typically around 50% overall
(all genotypes together). However, some studies of coinfected
patients with well preserved immune function -- such
as the Spanish PRESCO trial -- have produced SVR
rates approaching those of HIV negative individuals.
Unidad
de Enfermedades Infecciosas, Servicio de Medicina Interna,
Hospital Universitario de Valme, Hospital Universitario
Virgen del Rocío, Sevilla, Spain.
12/1/09
Reference
JA
Mira, A Gutierrez-Valencia, ID Gil, and others. Efficacy
and Safety of Pegylated Interferon plus Ribavirin in
HIV and Hepatitis C Virus-Coinfected Patients with Advanced
Immunosuppression. Clinical Infectious Diseases
49(8):e84-91. October 15, 2009.
|
FDA-approved
Combination Therapies for Chronic HCV Infection
