PMID- 30009715 OWN - NLM STAT- MEDLINE DCOM- 20201007 LR - 20211204 IS - 2212-3989 (Electronic) IS - 1871-5265 (Linking) VI - 20 IP - 1 DP - 2020 TI - Real Life Egyptian Experience of Daclatasvir Plus Sofosbuvir with Ribavirin in Naive Difficult to Treat HCV Patients. PG - 43-48 LID - 10.2174/1871526518666180716141806 [doi] AB - BACKGROUND: Chronic infection with Hepatitis C virus (HCV) is considered as a major cause for developing liver cirrhosis and hepatocellular carcinoma. A new era in HCV treatment is ongoing using Direct Acting Antiviral activity (DAA). The first approved DAA drug was Sofosbuvir which has a high tolerability and preferable pharmacokinetic profile. Another recently developed drug is Daclatasvir a first-in-class HCV NS5A replication complex inhibitor. Both drugs are administered orally once daily and have potent antiviral activity with wide genotypic coverage. METHODS: In the outpatient clinic, one hundred and fifty naive difficult to treat chronic HCV patients were recruited from Tropical Medicine Department at Fayoum public hospital. A combination of Daclatasvir (60 mg) and Sofosbuvir (400 mg) (DCV/SOF) has been administered for those patients once daily with Ribavirin (1200 mg or 1000 mg based on patients' weight on two divided doses) over a period of 12 weeks. All patients have been followed up for clinical, laboratory assessment and HCV PCR to detect the efficacy and safety of the therapy. RESULTS: Sustained Virologic Response rate (SVR12) was achieved in the vast majority of patients (90.67%). Cirrhotic patients showed lower SVR compared to non-cirrhotic patients (88.89% vs 90.91%, respectively). Around half of the patients (49.33%) developed adverse events (AEs) during treatment. The most common AEs were headache, fatigue and abdominal pain. CONCLUSION: The available evidence seems to suggest that combination therapy of (DCV/SOF with RBV) in the treatment of chronic HCV genotype IV naive difficult to treat patients either cirrhotic or non-cirrhotic is safe and effective. Monitoring for clinical and laboratory hepatic parameters was the basis for these findings. CI - Copyright(c) Bentham Science Publishers; For any queries, please email at epub@benthamscience.net. FAU - Wahsh, Engy A AU - Wahsh EA AD - Department of Clinical Pharmacy, Faculty of Pharmacy, Nahda University, Beni Suef, Egypt. FAU - Hussein, Amal K AU - Hussein AK AD - Department of Pharmaceutical Technology, Faculty of Pharmacy, Minia University, Minia, Egypt. FAU - Gomaa, Ahmed A AU - Gomaa AA AD - Department of Tropical Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt. FAU - Baraka, Mohamed A AU - Baraka MA AD - Department of Clinical Pharmacy, College of Pharmacy, Al Ain University, Al Ain, United Arab Emirates. AD - Department of Pharmacy Practice, College of Clinical Pharmacy, Imam Abdulrahman Bin Faisal University (University of Dammam), Saudi Arabia. FAU - Al-Deen Abead, Mohie AU - Al-Deen Abead M AD - Department of Biochemistry, Egyptian Ministry of Interior, Cairo, Egypt. LA - eng PT - Journal Article PL - United Arab Emirates TA - Infect Disord Drug Targets JT - Infectious disorders drug targets JID - 101269158 RN - 0 (Carbamates) RN - 0 (Drug Combinations) RN - 0 (Imidazoles) RN - 0 (Pyrrolidines) RN - 49717AWG6K (Ribavirin) RN - HG18B9YRS7 (Valine) RN - LI2427F9CI (daclatasvir) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM MH - Administration, Oral MH - Adult MH - Carbamates MH - Case-Control Studies MH - Drug Combinations MH - Egypt MH - Female MH - Hepacivirus/drug effects/growth & development MH - Hepatitis C, Chronic/*drug therapy/virology MH - Humans MH - Imidazoles/*administration & dosage/adverse effects MH - Liver Cirrhosis/drug therapy/*virology MH - Male MH - Middle Aged MH - Prospective Studies MH - Pyrrolidines MH - Ribavirin/*administration & dosage/adverse effects MH - Sofosbuvir/*administration & dosage/adverse effects MH - Sustained Virologic Response MH - Treatment Outcome MH - Valine/analogs & derivatives MH - Viral Load/drug effects OTO - NOTNLM OT - Chronic hepatitis C OT - daclatasvir OT - difficult to treat OT - hepatocellular carcinoma OT - inhibitor OT - ribavirin OT - sofosbuvir. EDAT- 2018/07/17 06:00 MHDA- 2020/10/08 06:00 CRDT- 2018/07/17 06:00 PHST- 2018/03/04 00:00 [received] PHST- 2018/07/09 00:00 [revised] PHST- 2018/07/10 00:00 [accepted] PHST- 2018/07/17 06:00 [pubmed] PHST- 2020/10/08 06:00 [medline] PHST- 2018/07/17 06:00 [entrez] AID - IDDT-EPUB-91729 [pii] AID - 10.2174/1871526518666180716141806 [doi] PST - ppublish SO - Infect Disord Drug Targets. 2020;20(1):43-48. doi: 10.2174/1871526518666180716141806.