PMID- 29994874
OWN - NLM
STAT- MEDLINE
DCOM- 20190125
LR  - 20211204
IS  - 1473-5687 (Electronic)
IS  - 0954-691X (Linking)
VI  - 30
IP  - 10
DP  - 2018 Oct
TI  - Outcome and adverse events in patients with chronic hepatitis C treated with 
      direct-acting antivirals: a clinical randomized study.
PG  - 1177-1186
LID - 10.1097/MEG.0000000000001192 [doi]
AB  - OBJECTIVE: New potent direct-acting antiviral (DAA) regimens against hepatitis C 
      virus have been approved in recent years. However, information about the rate of 
      adverse events (AEs) across different DAA regimens is limited. We aimed to 
      evaluate differences in AEs and treatment efficacy in patients with chronic 
      hepatitis C (CHC), genotype (GT) 1 or 3, randomized to two different treatment 
      arms, correspondingly. PATIENTS AND METHODS: We randomly assigned 96 patients in 
      a 1 : 1 ratio, to treatment for 12 weeks with either 
      paritaprevir/ombitasvir/ritonavir/dasabuvir/ribavirin (RBV) or 
      ledipasvir/sofosbuvir (SOF)/RBV if infected with GT1 (72 patients) or to 
      daclatasvir/SOF/RBV for 12 weeks or SOF/RBV for 24 weeks, if infected with GT3 
      (24 patients). Data on AEs were collected throughout the entire study period. 
      RESULTS: A total of 70 (97%) patients with CHC with GT1 and 20 (83%) patients 
      with GT3 achieved cure. The GT3 treatment arm was prematurely terminated, owing 
      to change in national treatment guidelines. Thus, only AEs for GT1 patients are 
      described. AEs occurred in 70 (97%) GT1 patients, and most common AEs were anemia 
      (n=56/78%), fatigue (n=53/74%), and headache (n=33/46%). No difference was 
      observed in relation to treatment group (P=1.0), anemia (P=1.0), or liver 
      cirrhosis (P=0.53). In seven (11%) patients, AEs assessed by the investigator to 
      be possibly related to the DAA regimen were still present 12 weeks after 
      treatment. CONCLUSIONS: We found no difference in AEs possibly related to the DAA 
      regimen in patients with CHC, but surprisingly, AEs possibly related to the DAA 
      regimen persisted in a significant number of patients after treatment. This 
      finding can be of importance for clinicians in relation to patient information 
      concerning AEs possibly related to DAA treatment.
FAU - Solund, Christina
AU  - Solund C
AD  - Departments of Infectious Diseases.
AD  - Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases and 
      Clinical Research Centre, Copenhagen University Hospital, Hvidovre.
AD  - Departments of Immunology and Microbiology.
FAU - Andersen, Ellen S
AU  - Andersen ES
AD  - Departments of Infectious Diseases.
FAU - Mossner, Belinda
AU  - Mossner B
AD  - Department of Infectious Diseases, Odense University Hospital.
FAU - Laursen, Alex L
AU  - Laursen AL
AD  - Department of Infectious Diseases, Aarhus University Hospital, Skejby.
FAU - Roge, Birgit T
AU  - Roge BT
AD  - Department of Medicine, Lillebaelt Hospital, Kolding, Denmark.
FAU - Kjaer, Mette S
AU  - Kjaer MS
AD  - Hepatology, Copenhagen University Hospital, Rigshospitalet.
AD  - Clinical Medicine, Faculty of Health and Medical Sciences, University of 
      Copenhagen, Copenhagen.
FAU - Gerstoft, Jan
AU  - Gerstoft J
AD  - Departments of Infectious Diseases.
AD  - Clinical Medicine, Faculty of Health and Medical Sciences, University of 
      Copenhagen, Copenhagen.
FAU - Christensen, Peer B
AU  - Christensen PB
AD  - Department of Infectious Diseases, Odense University Hospital.
AD  - Department of Clinical Research, Faculty of Health Sciences, University of 
      Southern Denmark, Odense.
FAU - Pedersen, Martin S
AU  - Pedersen MS
AD  - Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases and 
      Clinical Research Centre, Copenhagen University Hospital, Hvidovre.
AD  - Departments of Immunology and Microbiology.
AD  - Clinical Microbiology.
AD  - Department of Science and Environment, Roskilde University, Roskilde.
FAU - Schonning, Kristian
AU  - Schonning K
AD  - Clinical Medicine, Faculty of Health and Medical Sciences, University of 
      Copenhagen, Copenhagen.
AD  - Clinical Microbiology.
FAU - Fahnoe, Ulrik
AU  - Fahnoe U
AD  - Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases and 
      Clinical Research Centre, Copenhagen University Hospital, Hvidovre.
AD  - Departments of Immunology and Microbiology.
FAU - Bukh, Jens
AU  - Bukh J
AD  - Departments of Infectious Diseases.
AD  - Copenhagen Hepatitis C Program (CO-HEP), Department of Infectious Diseases and 
      Clinical Research Centre, Copenhagen University Hospital, Hvidovre.
AD  - Departments of Immunology and Microbiology.
FAU - Weis, Nina
AU  - Weis N
AD  - Departments of Infectious Diseases.
AD  - Clinical Medicine, Faculty of Health and Medical Sciences, University of 
      Copenhagen, Copenhagen.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Eur J Gastroenterol Hepatol
JT  - European journal of gastroenterology & hepatology
JID - 9000874
RN  - 0 (Anilides)
RN  - 0 (Antiviral Agents)
RN  - 0 (Benzimidazoles)
RN  - 0 (Carbamates)
RN  - 0 (Cyclopropanes)
RN  - 0 (Fluorenes)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Macrocyclic Compounds)
RN  - 0 (Sulfonamides)
RN  - 013TE6E4WV (ledipasvir)
RN  - 2302768XJ8 (ombitasvir)
RN  - 49717AWG6K (Ribavirin)
RN  - 56HH86ZVCT (Uracil)
RN  - 9DLQ4CIU6V (Proline)
RN  - CKR7XL41N4 (2-Naphthylamine)
RN  - DE54EQW8T1 (dasabuvir)
RN  - HG18B9YRS7 (Valine)
RN  - O3J8G9O825 (Ritonavir)
RN  - OU2YM37K86 (paritaprevir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - 2-Naphthylamine
MH  - Adult
MH  - Anemia/chemically induced
MH  - Anilides/adverse effects
MH  - Antiviral Agents/*adverse effects/therapeutic use
MH  - Benzimidazoles/adverse effects
MH  - Carbamates/adverse effects
MH  - Cyclopropanes
MH  - Drug Therapy, Combination/adverse effects
MH  - Fatigue/chemically induced
MH  - Female
MH  - Fluorenes/adverse effects
MH  - Genotype
MH  - Headache/chemically induced
MH  - Hepacivirus/*genetics
MH  - Hepatitis C, Chronic/*drug therapy/*virology
MH  - Humans
MH  - Lactams, Macrocyclic
MH  - Macrocyclic Compounds/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Proline/analogs & derivatives
MH  - Ribavirin/adverse effects
MH  - Ritonavir/adverse effects
MH  - Sofosbuvir/adverse effects
MH  - Sulfonamides/adverse effects
MH  - Treatment Outcome
MH  - Uracil/adverse effects/analogs & derivatives
MH  - Valine
MH  - Viral Load/drug effects
EDAT- 2018/07/12 06:00
MHDA- 2019/01/27 06:00
CRDT- 2018/07/12 06:00
PHST- 2018/07/12 06:00 [pubmed]
PHST- 2019/01/27 06:00 [medline]
PHST- 2018/07/12 06:00 [entrez]
AID - 10.1097/MEG.0000000000001192 [doi]
PST - ppublish
SO  - Eur J Gastroenterol Hepatol. 2018 Oct;30(10):1177-1186. doi: 
      10.1097/MEG.0000000000001192.