title: Aplastic anemia and severe pancytopenia during treatment with peg-interferon, ribavirin and telaprevir for chronic hepatitis C.
abstract: Telaprevir and Boceprevir are the first direct acting antivirals approved for chronic hepatitis C in combination with peg-interferon alfa and ribavirin. Pancytopenia due to myelotoxicity caused by these drugs may occur, but severe hematological abnormalities or aplastic anemia (AA) have not been described. We collected all cases of severe pancytopenia observed during triple therapy with telaprevir in four Spanish centers since approval of the drug in 2011. Among 142 cirrhotic patients receiving treatment, 7 cases of severe pancytopenia (5%) were identified and three were consistent with the diagnosis of AA. Mean age was 59 years, five patients had compensated cirrhosis and two patients had severe hepatitis C recurrence after liver transplantation. Severe pancytopenia was diagnosed a median of 10 wk after the initiation of therapy. Three patients had pre-treatment hematological abnormalities related to splenomegaly. In six patients, antiviral treatment was interrupted at the onset of hematological abnormalities. Two patients died due to septic complications and one patient due to acute alveolar hemorrhage. The remaining patients recovered. Severe pancytopenia and especially AA, are not rare during triple therapy with telaprevir in patients with advanced liver disease. Close monitoring is imperative in this setting to promptly detect serious hematological disorders and to prevent further complications.
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Sabela
authors.initials: S
authors.lastname: Lens
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Jose L
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Campillo
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Jose A
authors.initials: JA
authors.lastname: Carrión
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Teresa
authors.initials: T
authors.lastname: Broquetas
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Christie
authors.initials: C
authors.lastname: Perello
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: de la Revilla
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Mariño
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: María-Carlota
authors.initials: MC
authors.lastname: Londoño
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Jose M
authors.initials: JM
authors.lastname: Sánchez-Tapias
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Álvaro
authors.initials: Á
authors.lastname: Urbano-Ispizua
authors.affiliation: Sabela Lens, Zoe Mariño, María-Carlota Londoño, Jose M Sánchez-Tapias, Xavier Forns, Liver Unit, Hospital Clinic, IDIBAPS, CIBERehd, 08036 Barcelona, Spain.
authors.forename: Xavier
authors.initials: X
authors.lastname: Forns
mesh_terms: D000368:Aged; D000741:Anemia, Aplastic / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis / Q000628:therapy; D000998:Antiviral Agents / Q000009:adverse effects*; D001706:Biopsy; D001856:Bone Marrow Examination; D004359:Drug Therapy, Combination; D017809:Fatal Outcome; D005260:Female; D019698:Hepatitis C, Chronic / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects*; D010198:Pancytopenia / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis / Q000628:therapy; D011092:Polyethylene Glycols / Q000009:adverse effects*; D012254:Ribavirin / Q000009:adverse effects*; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D009842:Oligopeptides; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; D007372:Interferons
keywords: Aplastic anemia; Hepatitis C; Interferon; Protease inhibitors; Telaprevir