Treatment of chronic he1patitis C genotype 1 with peginterferon-alpha2a (40 kDa) plus ribavirin under routine clinical practice in Spain: early prediction of sustained virological response rate.
BACKGROUND
Sustained virological response rates of up to 52% have been obtained with peginterferon alpha2a (40 kDa) plus ribavirin in patients suffering from chronic hepatitis C genotype 1 in randomized-controlled trials.


OBJECTIVE
To assess early virological response and its clinical utility in predicting an sustained virological response in patients suffering from chronic hepatitis C genotype 1 in routine clinical practice in Spain.


METHODS
Treatment-naïve patients received pegylated interferon alpha2a (40 kDa) 180 microg/week plus ribavirin 1000/1200 mg/day for 48 weeks, and were followed for a further 24 weeks. Overall, 475 patients received at least one dose of medication and were included in the efficacy population.


RESULTS
The overall sustained virological response rate was 48%. Of those with week 12 virological data, 83% had an early virological response. The negative predictive value of an early virological response was 93%.


CONCLUSIONS
If sustained virological response is the goal, a treatment-decision based on a 12-week evaluation during routine clinical practice is feasible.
Diago
M
M
Hospital General de Valencia, Valencia, Spain. mdiagom@meditex.es
Olveira
A
A
Solá
R
R
Romero-Gómez
M
M
Moreno-Otero
R
R
Pérez
R
R
Salmerón
J
J
Enríquez
J
J
Planas
R
R
Gavilán
J C
JC
Del Olmo
J
J
Uribarrena
R
R
Sillero
C
C
Benítez
A
A
Sánchez-Galdón
S
S
Dalmau
B
B
Eraña
L
L
Montoro
M
M
Portu
J
J
Garijo
J M
JM
Barniol
R
R
Domínguez
A
A
Rota
R
R
Olcoz
J L
JL
Antón
M
M
Pamplona
X
X
Casanovas
T
T
Jiménez
E
E
Huarte
M
M
Díaz
F
F
Sánchez-Ruano
J
J
Orive
M
M
Muñoz-Sánchez
M
M
Roset
M
M
D000328:Adult; D000998:Antiviral Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011994:Recombinant Proteins; D012254:Ribavirin / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a