High Efficacy of ombitasvir/paritaprevir/ritonavir plus dasabuvir in hepatitis C genotypes 4 and 1-infected patients with severe chronic kidney disease.

Abstract

BACKGROUND & AIMS:

Limited data have shown high efficacy of co-formulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in the treatment of hepatitis C virus (HCV) genotype (GT)-4, and combined with dasabuvir (DSV) in GT1 patients, with chronic kidney disease (CKD) stages 4-5 (<30 mL/min/1.73 m2 ). We assessed real-world safety and efficacy of OBV/PTV/r ± DSV in GT1- and 4-infected patients.

METHODS:

In this observational cohort (n = 67), we enrolled stages 4-5 CKD treatment-naïve or Peginterferon/RBV-experienced GT4-infected patients (n = 32) treated for 12-24 weeks with OBV/PTV/r ± RBV, and plus DSV in GT1 patients (n = 35, including 3 with GT1/4 co-infection). RBV was dosed by physician discretion between 200 mg weekly and 200 mg daily. Primary endpoints were SVR12, calculated on intention-to-treat (ITT) basis, and occurrence of serious adverse events.

RESULTS:

The mean age of the cohort was 45.7 ± 12.7 years, 50.7% were females, 20.9% had cirrhosis, 35.8% were treatment-experienced and 97% were on haemodialysis. Three patients (F4) received 24-week treatment, 2 with GT4, and 1 with GT1a; and 19.4% were treated without RBV, including 9 GT1, and 4 GT4. Overall, 65 (97.1%) patients achieved SVR12, including 100% of those with a post-treatment follow-up (modified ITT analysis). Of the two patients without SVR12, one died from sepsis-related complications and the other from a myocardial infarction 2 weeks after completing therapy. Grades 3-4 anaemia occurred in 8.9%.

CONCLUSION:

A 12-week regimen of OBV/PTV/r ± DSV with or without RBV is highly effective with a favourable safety profile amongst GT4 and GT1 patients with CKD stages 4-5. SVR12 rates were high regardless of patient characteristics.

• Authors: Faisal M Sanai, Abdullah S Alghamdi, Ahmad A Afghani, Khalid Alswat, Adnan AlZanbagi, Mosfer N Alghamdi, Abdallah AlMousa, Mohammed Aseeri, Abdullah M Assiri, Mohamed A Babatin
• Journal: Liver international : official journal of the International Association for the Study of the Liver (Liver Int) Vol. 38 Issue 8 Pg. 1395-1401 (08 2018) ISSN: 1478-3231 [Electronic] United States
• PMID: 29288514 (Publication Type: Journal Article, Observational Study)
• Copyright: © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Chemical References

• Anilides
• Antiviral Agents
• Carbamates
• Cyclopropanes
• Lactams, Macrocyclic
• Macrocyclic Compounds
• Sulfonamides
• ombitasvir
• Ribavirin
• Uracil
• Proline
• 2-Naphthylamine
• dasabuvir
• Valine
• Ritonavir
• paritaprevir

Topics

• 2-Naphthylamine
• Adult
• Anilides (therapeutic use)
• Antiviral Agents (therapeutic use)
• Carbamates (therapeutic use)
• Cohort Studies
• Cyclopropanes
• Drug Therapy, Combination
• Female
• Hepacivirus (genetics)
• Hepatitis C, Chronic (complications, drug therapy)
• Humans
• Lactams, Macrocyclic
• Liver Cirrhosis (virology)
• Macrocyclic Compounds (therapeutic use)
• Male
• Middle Aged
• Proline (analogs & derivatives)
• Registries
• Renal Insufficiency, Chronic (complications)
• Ribavirin (therapeutic use)
• Ritonavir (therapeutic use)
• Saudi Arabia
• Sulfonamides (therapeutic use)
• Sustained Virologic Response
• Uracil (analogs & derivatives, therapeutic use)
• Valine