853
An Open-label, Multicenter Study of the Efficacy and Safety of Peg-interferon-A-2a Alone or in Combination with Ribavirin in Patients with HIV/HCV Co-infection
Enrique Ortega*1, A Martin1, C Barros2, J Garcia3, K Aguirrebengoa4, V Asensi5, R Rubio6, F Pulido6, J Gonzalez7, J Portu8, and M78024 Team
1Hosp Gen Univ Valencia, Spain; 2Hosp de Mostoles, Madrid, Spain; 3Hosp Virgen del Rosell, Murcia, Spain; 4Hosp de Cruces, Spain; 5Hosp Gen de Asturias, Oviedo, Spain; 6Hosp 12 de Octubre, Madrid, Spain; 7Hosp La Paz, Madrid, Spain; and 8Hosp Vitoria, Spain
Background: Effective eradicative treatment for hepatitis
C virus (HCV) is urgently needed. It has been hypothesized that ribavirin (RBV) may interact with certain ART agents. Thus,
it has been thought desirable to limit patients’ exposure to this agent. Our objective was to evaluate the
efficacy and safety of pegylated interferon treatment
alone or in combination with RBV in patients with HIV/HCV co-infection.
Methods: All patients received mono-therapy with pegINF 180 mg/week
for the first 4 weeks of treatment. Patients with undetectable HCV RNA
at week 4 remained on peg-INF mono-therapy to complete a total of 48 weeks. Patients
with detectable levels commenced treatment with RBV 800 mg/day until the end.
Results: We recruited 312 patients at 27 centers in Spain. Baseline
characteristics are presented in the table. After 4 weeks of pegINF monotherapy, 24.4%of
patients had undetectable HCV RNA. These individuals continued monotherapy and the remaining patients commenced
combination therapy with the addition of RBV 800 mg/day. The overall rate of
sustained virological response was 27.9%, but it
differed according to the response at week 4. The rate of sustained virological response in patients who received monotherapy for 48 weeks was 46.7% vs
22.1% in patients who received monotherapy for 4 week
and combination therapy for 44 weeks more. Among patients infected with HCV
genotype 1, the rates of sustained virological
response were 37.5% with monotherapy and 16.9% with combination
therapy. The corresponding rates among patients infected with genotype 2 or 3
were 68.8% and 59.6% and in patients infected with genotypes 4, 66.7% and 20.6%
|
|
pegIFN a-2a
|
pegIFN a-2a
+ RBV
|
Total
|
|
n
|
83
|
229
|
312
|
|
Male
(% of patients)
|
86.7
|
69.0
|
73.7
|
|
HCV
genotype n (%)
|
|
|
|
|
Genotypes
1 // Genotypes 2 or 3 // Genotype 4
|
30.1 // 59 // 6
|
56.8 // 26.2 // 14.8
|
49.7 // 34.9 // 2.9
|
|
HIV
RNA detectable (% of patients)
|
50.6
|
58.5%
|
56.4
|
|
Mean
CD4+ cell count (cells/mm3)
|
715.22
|
655.1
|
671.19
|
|
Patients
on HAART (% of patients)
|
84.3
|
83.4
|
83.7
|
Conclusions: Our
results demonstrate that pegINF given alone or in
combination with RBV is effective and safe in patients with HCV/HIV
co-infection. Patients who were HCV RNA-negative after 4 weeks of pegINF produced a sustained virological
response rate of 46.7%, whereas the addition of RBV at week 4 in patients with detectable
HCV RNA produced a sustained virological response
rate of 22.1%.
|
