PMID- 31925434
OWN - NLM
STAT- MEDLINE
DCOM- 20210624
LR  - 20210624
IS  - 1878-3503 (Electronic)
IS  - 0035-9203 (Linking)
VI  - 114
IP  - 4
DP  - 2020 Apr 8
TI  - Sustained virologic response and changes in liver fibrosis parameters following 
      12-wk administration of generic sofosbuvir and daclatasvir in HIV/HCV-coinfected 
      patients with HCV genotype 4 infection.
PG  - 232-240
LID - 10.1093/trstmh/trz120 [doi]
AB  - BACKGROUND: Novel direct-acting antiviral agents have shown great efficacy and 
      tolerability in HCV-monoinfected patients. However, data are lacking regarding 
      their efficacy and safety in HIV/HCV-genotype (GT) 4-coinfected patients. 
      METHODS: A single-centre, prospective study including HIV/HCV-GT 4-coinfected 
      patients who were treated with sofosbuvir and daclatasvir (SOF/DCV) was conducted 
      for 12 wk. Sustained virological response (SVR) at week 12 post-treatment 
      (SVR12), adverse events (AEs) and changes in liver stiffness measurement (LSM) at 
      SVR12 in comparison with baseline were evaluated. RESULTS: SVR12 was achieved in 
      46 of 50 patients (92%). No significant difference in SVR12 was noticed among 
      patients who received antiretroviral therapy (ART) regimens compared with those 
      who did not receive ART regimens or between those with insignificant fibrosis 
      (<F2) and those with significant fibrosis (>/=F2) (p=0.9 and p=0.3, respectively). 
      AEs occurred in 45 (90%) patients. The most frequent AEs were fatigue, headache 
      and nausea. No treatment-related serious AEs or deaths were reported. HIV control 
      was not compromised. LSM, fibrosis 4 score and aspartate 
      aminotransferase-to-platelet ratio index showed a significant decrease at SVR12 
      when compared with baseline (p=0.0004, p=0.0003 and p<0.0001, respectively). 
      Logistic regression analysis showed no association between baseline variables and 
      SVR12 while significant fibrosis (>/=F2) was the only baseline variable that was 
      significantly associated with improvement of LSM at SVR12. CONCLUSION: SOF/DCV 
      achieved a high SVR12 and was well-tolerated in HIV/HCV-GT 4-coinfected patients.
CI  - (c) The Author(s) 2020. Published by Oxford University Press on behalf of Royal 
      Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, 
      please e-mail: journals.permissions@oup.com.
FAU - Cordie, Ahmed
AU  - Cordie A
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo 
      University, Cairo 11562, Egypt.
FAU - Elsharkawy, Aisha
AU  - Elsharkawy A
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo 
      University, Cairo 11562, Egypt.
FAU - Abdel Alem, Shereen
AU  - Abdel Alem S
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo 
      University, Cairo 11562, Egypt.
FAU - Meshaal, Safa
AU  - Meshaal S
AD  - Clinical pathology Department, Faculty of Medicine, Cairo University, Cairo 
      11562, Egypt.
FAU - El Akel, Wafaa
AU  - El Akel W
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo 
      University, Cairo 11562, Egypt.
FAU - Abdellatif, Zeinab
AU  - Abdellatif Z
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo 
      University, Cairo 11562, Egypt.
FAU - Kamal, Walid
AU  - Kamal W
AD  - Preventive sector, Ministry of Health and Population, Cairo 11516, Egypt.
FAU - Al Askalany, Mahmoud
AU  - Al Askalany M
AD  - Imbaba Fever Hospital, Ministry of Health and Population, Cairo 12651, Egypt.
FAU - Kamel, Sherif
AU  - Kamel S
AD  - Imbaba Fever Hospital, Ministry of Health and Population, Cairo 12651, Egypt.
FAU - Abdel Aziz, Hossam
AU  - Abdel Aziz H
AD  - Department of Hepatology, Faculty of Medicine, Ain Shams University, Cairo 11591, 
      Egypt.
FAU - Kandeel, Amr
AU  - Kandeel A
AD  - Preventive sector, Ministry of Health and Population, Cairo 11516, Egypt.
FAU - Esmat, Gamal
AU  - Esmat G
AD  - Endemic Medicine and Hepatology Department, Faculty of Medicine, Cairo 
      University, Cairo 11562, Egypt.
LA  - eng
PT  - Journal Article
PL  - England
TA  - Trans R Soc Trop Med Hyg
JT  - Transactions of the Royal Society of Tropical Medicine and Hygiene
JID - 7506129
RN  - 0 (Antiviral Agents)
RN  - 0 (Carbamates)
RN  - 0 (Imidazoles)
RN  - 0 (Pyrrolidines)
RN  - 49717AWG6K (Ribavirin)
RN  - HG18B9YRS7 (Valine)
RN  - LI2427F9CI (daclatasvir)
RN  - WJ6CA3ZU8B (Sofosbuvir)
SB  - IM
MH  - Antiviral Agents/therapeutic use
MH  - Carbamates
MH  - *Coinfection/drug therapy
MH  - Drug Therapy, Combination
MH  - Genotype
MH  - *HIV Infections/complications/drug therapy
MH  - Hepacivirus/genetics
MH  - *Hepatitis C, Chronic/complications/drug therapy
MH  - Humans
MH  - Imidazoles
MH  - Liver Cirrhosis/complications/drug therapy
MH  - Prospective Studies
MH  - Pyrrolidines
MH  - Ribavirin/therapeutic use
MH  - Sofosbuvir/therapeutic use
MH  - Sustained Virologic Response
MH  - Treatment Outcome
MH  - Valine/analogs & derivatives
OTO - NOTNLM
OT  - HIV/HCV-coinfected patients
OT  - direct-acting antivirals
OT  - genotype 4
OT  - liver fibrosis
OT  - safety
OT  - sustained virologic response
EDAT- 2020/01/12 06:00
MHDA- 2021/06/25 06:00
CRDT- 2020/01/12 06:00
PHST- 2019/06/11 00:00 [received]
PHST- 2019/09/19 00:00 [revised]
PHST- 2019/10/30 00:00 [accepted]
PHST- 2020/01/12 06:00 [pubmed]
PHST- 2021/06/25 06:00 [medline]
PHST- 2020/01/12 06:00 [entrez]
AID - 5699686 [pii]
AID - 10.1093/trstmh/trz120 [doi]
PST - ppublish
SO  - Trans R Soc Trop Med Hyg. 2020 Apr 8;114(4):232-240. doi: 10.1093/trstmh/trz120.