RT Journal Article
T1 Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection.
A1 Macías, Juan
A1 López-Cortés, Luis F
A1 Téllez, Francisco
A1 Recio, Eva
A1 Ojeda-Burgos, Guillermo
A1 Ríos, Maria José
A1 Rivero-Juárez, Antonio
A1 Delgado, Marcial
A1 Rivas, Jeremías
A1 Pineda, Juan A
K1 Brazo
K1 Coinfección
K1 Intervalos de confianza
K1 Genotipo
K1 Infecciones por VIH
K1 Hepacivirus
K1 Humanos
K1 Análisis de la intención de tratar
K1 Interferon-alfa
K1 Glicoles de polietileno
K1 Ribavirina
K1 Tiazoles
AB BACKGROUNDNitazoxanide (NTZ) plus pegylated interferon and ribavirin (Peg-IFN/RBV) improved the sustained virological response (SVR) achieved with Peg-IFN/RBV in hepatitis C virus genotype 4 (HCV-4)-monoinfected patients. There are no data currently on the efficacy of Peg-IFN/RBV plus NTZ for human immunodeficiency virus (HIV)/HCV-4 coinfection. Therefore, the objectives of this clinical trial were to assess the efficacy and to evaluate the safety of Peg-IFN/RBV plus NTZ in HIV/HCV-4-coinfected patients.PATIENTS AND METHODSThis was an open-label, single arm, multicenter phase II pilot clinical trial (NCT01529073) enrolling HIV-infected individuals with HCV-4 chronic infection, naïve to HCV therapy. Patients were treated with NTZ 500 mg bid for 4 weeks, followed by NTZ 500 mg bid plus Peg-IFN alpha-2b 1.5 μg/kg/week plus weight-adjusted RBV during 48 weeks. Analyses were done by intention-to-treat (ITT, missing = failure). A historical cohort of HIV/HCV-4-infected patients treated with Peg-IFN alpha-2b and RBV at the same area was used as control.RESULTSTwo (9.5%) of 21 patients included in the trial compared with 5 (21.7%) of 23 patients included in the historical cohort achieved SVR (SVR risk difference, -12.2%; 95% confidence interval, -33.2% to 8.8%; p = 0.416). Virological failure was due to lack of response in 13 (62%) individuals recruited in the trial. Two (9.5%) patients included in the trial and two (9.5%) individuals from the historical cohort discontinued permanently due to adverse events.CONCLUSIONSNo increase in SVR was observed among HIV/HCV-4-coinfected patients receiving Peg-IFN/RBV plus NTZ compared with a historical cohort treated with Peg-IFN/RBV. Interruptions due to adverse events of Peg-IFN/RBV plus NTZ were similar to those of dual therapy.
PB Biomed Central
YR 2015
FD 2015-12-07
LK http://hdl.handle.net/10668/2345
UL http://hdl.handle.net/10668/2345
LA en
NO Macías J, López-Cortés LF, Téllez F, Recio E, Ojeda-Burgos G, Ríos MJ, et al. Low Efficacy of Pegylated Interferon plus Ribavirin plus Nitazoxanide for HCV Genotype 4 and HIV Coinfection. PLoS One. 2015;10(12):e0143492.
NO Journal Article; Research Support, Non-U.S. Gov't; TRIAL REGISTRATIONClinicalTrials.gov NCT01529073.
DS RISalud
RD Apr 18, 2025