TY - JOUR
T1 - Antiviral effects and safety of telaprevir, peginterferon alfa-2a, and ribavirin for 28 days in hepatitis C patients
AU - Lawitz, Eric
AU - Rodriguez-Torres, Maribel
AU - Muir, Andrew J.
AU - Kieffer, Tara L.
AU - McNair, Lindsay
AU - Khunvichai, Ariya
AU - McHutchison, John G.
N1 - Funding Information:
This study was supported by Vertex Pharmaceuticals Incorporated. The authors who have taken part in the research of this paper declared that they have a relationship with the manufacturers of the drugs involved either in the past or present and that they received funding from the manufacturers to carry out their research. Drs. Kieffer, McNair and Khunvichai are employees of Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA.
PY - 2008/8
Y1 - 2008/8
N2 - Background/Aims: This study assessed the safety and antiviral effects of telaprevir (VX-950) in combination with peginterferon alfa-2a and ribavirin. Methods: Twelve treatment-nai{dotless}̈ve patients with chronic genotype 1 hepatitis C virus infection received telaprevir (750 mg q8h), peginterferon alfa-2a (180 μg/week), and ribavirin (1000 or 1200 mg/day) for 28 days. Patients could then start off-study treatment with peginterferon alfa-2a and ribavirin for up to 44 weeks, at the discretion of the investigator and patient. Results: The combination of telaprevir, peginterferon alfa-2a, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. Rash or pruritus occurred in 5 of the 12 patients; all cases resolved either during or after the end of telaprevir treatment. All 12 patients had undetectable HCV RNA levels by day 28 (rapid viral response, RVR). Eight patients completed 44 weeks of off-study peginterferon alfa-2a and ribavirin treatment. Eight patients achieved a sustained viral response (SVR), including one patient who received only 22 weeks of treatment. Conclusions: The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR.
AB - Background/Aims: This study assessed the safety and antiviral effects of telaprevir (VX-950) in combination with peginterferon alfa-2a and ribavirin. Methods: Twelve treatment-nai{dotless}̈ve patients with chronic genotype 1 hepatitis C virus infection received telaprevir (750 mg q8h), peginterferon alfa-2a (180 μg/week), and ribavirin (1000 or 1200 mg/day) for 28 days. Patients could then start off-study treatment with peginterferon alfa-2a and ribavirin for up to 44 weeks, at the discretion of the investigator and patient. Results: The combination of telaprevir, peginterferon alfa-2a, and ribavirin was well tolerated, with no serious adverse events or treatment discontinuations. Rash or pruritus occurred in 5 of the 12 patients; all cases resolved either during or after the end of telaprevir treatment. All 12 patients had undetectable HCV RNA levels by day 28 (rapid viral response, RVR). Eight patients completed 44 weeks of off-study peginterferon alfa-2a and ribavirin treatment. Eight patients achieved a sustained viral response (SVR), including one patient who received only 22 weeks of treatment. Conclusions: The combination of telaprevir, peginterferon alfa-2a, and ribavirin was generally well tolerated. Events of pruritus and rash resolved during or after end of telaprevir dosing. All 12 patients achieved an RVR.
KW - Combination therapy
KW - Hepatitis C therapy
KW - Telaprevir
UR - http://www.scopus.com/inward/record.url?scp=46149127335&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=46149127335&partnerID=8YFLogxK
U2 - 10.1016/j.jhep.2008.03.027
DO - 10.1016/j.jhep.2008.03.027
M3 - Article
C2 - 18486984
AN - SCOPUS:46149127335
SN - 0168-8278
VL - 49
SP - 163
EP - 169
JO - Journal of Hepatology
JF - Journal of Hepatology
IS - 2
ER -