PMID- 30950069
OWN - NLM
STAT- MEDLINE
DCOM- 20220208
LR  - 20220506
IS  - 1096-9071 (Electronic)
IS  - 0146-6615 (Linking)
VI  - 94
IP  - 2
DP  - 2022 Feb
TI  - High success rates for the use of ombitasvir/paritaprevir/ritonavir containing 
      regimens in treatment of naive and experienced chronic hepatitis C genotype 4: 
      Real world results.
PG  - 667-674
LID - 10.1002/jmv.25478 [doi]
AB  - INTRODUCTION AND AIMS: Treatment of hepatitis C virus (HCV) genotype 4 patient 
      with fixed dose combination of ombitasvir-paritaprevir-ritonavir plus ribavirin 
      (OBV/rPTV/RBV) has been proven efficacy and safety in many clinical trials. The 
      current study reports the efficacy and safety of OBV/rPTV/RBV (for 
      treatment-naive), and OBV/rPTV/RBV/sofosbuvir (SOF) (for treatment-experienced), 
      in chronic HCV genotype 4 patients in real life settings. METHODS: Prospective 
      cohort study including all adult chronic HCV genotype 4 patients who were 
      scheduled to receive OBV/rPTV/RBV +/- SOF for 12 or 24 weeks in New Cairo Viral 
      Hepatitis Treatment Center. The primary efficacy endpoint was a virologic 
      response at posttreatment week 12 (SVR12). Changes in hematological parameters, 
      liver biochemical profile and fibrosis-4 index (FIB-4), as well as clinical and 
      laboratory adverse events (AEs) across follow up visits (week 4, end of treatment 
      [EOT], and SVR12), were recorded. RESULTS: Our study included 325 patients (age; 
      47.63 +/- 12.63 years, 55.38% [n = 180] men). Most of the included patients 
      (89.85%, n = 292) were treatment naive and only 7% (n = 23) had liver cirrhosis. 
      Overall, SVR12 was attained by 98.44% (316 of 321) of the patients; 97.15% (307 
      of 316) of patients who received 12 weeks of OBV/rPTV/RBV +/- SOF and 100% (9 of 9) 
      of patients who received 24 weeks of OBV/rPTV/RBV as assessed by modified 
      intention to treat analysis. There was a significant improvement of baseline 
      alanine aminotransferase, aspartate aminotransferase, hemoglobin, FIB-4 at SVR12 
      (P < 0.05). The most common reported AEs were anemia (n = 106), fatigue (n = 41) 
      and elevated indirect bilirubin (n = 37). CONCLUSION: OBV/rPTV/RBV (+/-SOF) is a 
      highly effective therapy for chronic HCV patients in real life settings.
CI  - (c) 2019 Wiley Periodicals, Inc.
FAU - El Kassas, Mohamed
AU  - El Kassas M
AD  - Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, 
      Egypt.
FAU - Alboraie, Mohamed
AU  - Alboraie M
AD  - Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.
FAU - Omar, Heba
AU  - Omar H
AUID- ORCID: 0000-0002-9707-1141
AD  - Department of Endemic Medicine and Hepatology, Faculty of Medicine, Cairo 
      University, Cairo, Egypt.
FAU - El Latif, Yasmeen Abd
AU  - El Latif YA
AD  - Tropical Medicine Department, Ain shams university, Cairo, Egypt.
FAU - Algaber, Mohammed Abd
AU  - Algaber MA
AD  - Gastroenterology & Hepatology Department, Police Authority Hospital, Cairo, 
      Egypt.
FAU - El Tahan, Adel
AU  - El Tahan A
AD  - New Cairo Viral Hepatitis Treatment Unit, New Cairo Hospital, Cairo, Egypt.
FAU - El Halwagy, Hesham
AU  - El Halwagy H
AD  - Hepatology and Gastroenterology and Infectious Diseases, National Hepatology and 
      Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
FAU - Afify, Shimaa
AU  - Afify S
AD  - Hepatology and Gastroenterology and Infectious Diseases, National Hepatology and 
      Tropical Medicine Research Institute (NHTMRI), Cairo, Egypt.
FAU - Elserafy, Magdy
AU  - Elserafy M
AD  - Department of Endemic Medicine and Hepatology, Faculty of Medicine, Cairo 
      University, Cairo, Egypt.
FAU - Elsaeed, Kadry
AU  - Elsaeed K
AD  - Internal Medicine Department, Faculty of Medicine, Ain Shams University, Cairo, 
      Egypt.
FAU - Doss, Wahid
AU  - Doss W
AD  - Department of Endemic Medicine and Hepatology, Faculty of Medicine, Cairo 
      University, Cairo, Egypt.
LA  - eng
PT  - Journal Article
DEP - 20190415
PL  - United States
TA  - J Med Virol
JT  - Journal of medical virology
JID - 7705876
RN  - 0 (Anilides)
RN  - 0 (Antiviral Agents)
RN  - 0 (Cyclopropanes)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Sulfonamides)
RN  - 2302768XJ8 (ombitasvir)
RN  - 49717AWG6K (Ribavirin)
RN  - 9DLQ4CIU6V (Proline)
RN  - HG18B9YRS7 (Valine)
RN  - O3J8G9O825 (Ritonavir)
RN  - OU2YM37K86 (paritaprevir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Adult
MH  - Anemia/etiology
MH  - Anilides/therapeutic use
MH  - Antiviral Agents/adverse effects/*therapeutic use
MH  - Cyclopropanes/therapeutic use
MH  - Drug Therapy, Combination
MH  - Fatigue/etiology
MH  - Female
MH  - Genotype
MH  - Hepacivirus/*genetics
MH  - Hepatitis C, Chronic/complications/*drug therapy/virology
MH  - Humans
MH  - Lactams, Macrocyclic/therapeutic use
MH  - Liver Cirrhosis/*epidemiology/etiology
MH  - Male
MH  - Middle Aged
MH  - Proline/analogs & derivatives/therapeutic use
MH  - Prospective Studies
MH  - Ribavirin/therapeutic use
MH  - Ritonavir/therapeutic use
MH  - Sofosbuvir/therapeutic use
MH  - Sulfonamides/therapeutic use
MH  - Sustained Virologic Response
MH  - Valine/therapeutic use
OTO - NOTNLM
OT  - genotype 4
OT  - hepatitis C virus
OT  - ombitasvir
OT  - paritaprevir
OT  - real-world
OT  - sofosbuvir
EDAT- 2019/04/06 06:00
MHDA- 2022/02/09 06:00
CRDT- 2019/04/06 06:00
PHST- 2019/03/29 00:00 [revised]
PHST- 2019/03/03 00:00 [received]
PHST- 2019/03/29 00:00 [accepted]
PHST- 2019/04/06 06:00 [pubmed]
PHST- 2022/02/09 06:00 [medline]
PHST- 2019/04/06 06:00 [entrez]
AID - 10.1002/jmv.25478 [doi]
PST - ppublish
SO  - J Med Virol. 2022 Feb;94(2):667-674. doi: 10.1002/jmv.25478. Epub 2019 Apr 15.