Boceprevir or Telaprevir Based Triple Therapy against Chronic Hepatitis C in HIV Coinfection: Real-Life Safety and Efficacy.
OBJECTIVE
Clinical trials of therapy against chronic hepatitis C virus (HCV) infection including boceprevir (BOC) or telaprevir (TVR) plus pegylated interferon and ribavirin (PR) have reported considerably higher response rates than those achieved with PR alone. This study sought to evaluate the efficacy and safety of triple therapy including BOC or TVR in combination with PR in HIV/HCV-coinfected patients under real-life conditions.


METHODS
In a multicentre study conducted in 24 sites throughout five European countries, all HIV/HCV-coinfected patients who initiated a combination of BOC or TVR plus PR and who had at least 60 weeks of follow-up, were analyzed. Sustained virologic response 12 weeks after the scheduled end of therapy date (SVR12) and the rate of discontinuations due to adverse events (AE) were evaluated.


RESULTS
Of the 159 subjects included, 127 (79.9%) were male, 45 (34.4%) were treatment-naïve for PR and 60 (45.4%) showed cirrhosis. SVR12 was observed in 31/46 (67.4%) patients treated with BOC and 69/113 (61.1%) patients treated with TVR. Overall discontinuations due to AE rates were 8.7% for BOC and 8% for TVR. Grade 3 or 4 hematological abnormalities were frequently observed; anemia 7%, thrombocytopenia 17.2% and neutropenia 16.4%.


CONCLUSIONS
The efficacy and safety of triple therapy including BOC or TVR plus PR under real-life conditions of use in the HIV/HCV-coinfected population was similar to what is observed in clinical trials. Hematological side effects are frequent but manageable.
Unit of Infectious Diseases and Microbiology, Valme University Hospital and Seville Institute of Biomedicine (IBiS), Seville, Spain; RIS-HEP07 Study Group of the Spanish AIDS Research Network.
Karin
K
Neukam
Department of Medicine I, Bonn University Hospital, Bonn-Venusberg, Germany; Matei Bals National Institute of Infectious Diseases, Bucharest, Romania.
Daniela I
DI
Munteanu
RIS-HEP07 Study Group of the Spanish AIDS Research Network; Unit of Infectious Diseases, Reina Sofía University Hospital, Maimónides Institute of Biomedical Investigation of Cordoba (IMIBIC), Cordoba, Spain.
Antonio
A
Rivero-Juárez
Infektiologikum Frankfurt, Frankfurt/Main, Germany.
Thomas
T
Lutz
Division of Infectious Diseases & Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Jan
J
Fehr
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna and Vienna HIV & Liver Study Group, Vienna, Austria.
Mattias
M
Mandorfer
Department of Infectious Diseases/HIV Medicine, Royal Free London NHS Foundation Trust, London, United Kingdom.
Sanjay
S
Bhagani
RIS-HEP07 Study Group of the Spanish AIDS Research Network; Infectious Diseases, Microbiology and Preventive Medicine, Virgen del Rocío University Hospital and Seville Institute of Biomedicine (IBiS), Seville, Spain.
Luis F
LF
López-Cortés
Department of Medicine II, Frankfurt University Hospital, Frankfurt/Main, Germany.
Annette
A
Haberl
Division of Infectious Diseases & Hospital Epidemiology, University Hospital Basel, Basel, Switzerland.
Marcel
M
Stoeckle
RIS-HEP07 Study Group of the Spanish AIDS Research Network; Unit of Infectious Diseases, Virgen de la Victoria University Hospital, Malaga, Spain.
Manuel
M
Márquez
Praxis Hohenstaufenring, Cologne, Germany.
Stefan
S
Scholten
RIS-HEP07 Study Group of the Spanish AIDS Research Network; Infectious Diseases Unit, La Princesa University Hospital, Madrid, Spain.
Ignacio
I
de Los Santos-Gil
Center for HIV and Hepatogastroenterology, Dusseldorf, Germany.
Stefan
S
Mauss
RIS-HEP07 Study Group of the Spanish AIDS Research Network; Unit of Infectious Diseases, Reina Sofía University Hospital, Maimónides Institute of Biomedical Investigation of Cordoba (IMIBIC), Cordoba, Spain.
Antonio
A
Rivero
Infectious Diseases Unit, Torrecardenas University Hospital, Almeria, Spain.
Antonio
A
Collado
Unit of Infectious Diseases, Carlos Haya Regional University Hospital, Malaga, Spain.
Marcial
M
Delgado
Department of Medicine I, Bonn University Hospital, Bonn-Venusberg, Germany.
Juergen K
JK
Rockstroh
Unit of Infectious Diseases and Microbiology, Valme University Hospital and Seville Institute of Biomedicine (IBiS), Seville, Spain; RIS-HEP07 Study Group of the Spanish AIDS Research Network.
Juan A
JA
Pineda
D000328:Adult; D060085:Coinfection / Q000188:drug therapy / Q000473:pathology; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005260:Female; D006678:HIV / Q000187:drug effects; D015658:HIV Infections / Q000188:drug therapy* / Q000473:pathology / Q000821:virology; D016174:Hepacivirus / Q000187:drug effects; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage*; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives*; D012254:Ribavirin / Q000008:administration & dosage; D016896:Treatment Outcome
D009842:Oligopeptides; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline