Beshoy Yanny1,2, Sammy Saab3,4, Francisco Durazo3,4, Nyan Latt5, Amanda Mitry6, Mira Moris Mikhail7,8, Ramy M Hanna3,7,8, Antony Aziz3,4, Amandeep Sahota9,10,11. 1. Department of Medicine, University of California Los Angeles, 200 Medical Plaza, Suite 214, Los Angeles, CA, 90095, USA. byanny@mednet.ucla.edu. 2. Department of Surgery, University of California Los Angeles, Los Angeles, CA, USA. byanny@mednet.ucla.edu. 3. Department of Medicine, University of California Los Angeles, 200 Medical Plaza, Suite 214, Los Angeles, CA, 90095, USA. 4. Department of Surgery, University of California Los Angeles, Los Angeles, CA, USA. 5. Ochsner Clinic Foundation, Jefferson, USA. 6. Claremont Graduate University, Claremont, USA. 7. Department of Nephrology, University of California Los Angeles, Los Angeles, CA, USA. 8. Biological Science, Biola University, La Mirada, USA. 9. Department of Medicine, Kaiser Permanente Los Angeles Medical Center, Los Angeles, USA. 10. Department of Gastroenterology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, USA. 11. Department of Transplant Hepatology, Kaiser Permanente Los Angeles Medical Center, Los Angeles, USA.
Abstract
AIM: Results of recent studies have confirmed the efficacy of an 8-week course of ledipasvir/sofosbuvir (LDV/SOF) in patients who are non-cirrhotics, native to treatment, are infected with hepatitis C (HCV) genotype 1, and have HCV viral load < 6 million IU/mL. However, there are limited data on a shortened treatment course in patients who are over the age of 65. METHODS: A retrospective study was performed to examine the safety, tolerability, and sustained viral response rates (SVR) of the 8-week LDV/SOF therapy compared to the 12-week LDV/SOF therapy among non-cirrhotic, treatment-naïve, genotype 1 HCV patients with viral load < 6 million IU/mL who are 65 years of age or older. RESULTS: A total of 454 patients were identified of which 182 non-cirrhotic, genotype 1 HCV-RNA < 6 million IU/mL patients received the 8-week LDV/SOF treatment and 272 received the 12-week LDV/SOF treatment. Mean [± standard deviation (SD)] aspartate aminotransferase to platelet ratio index score for the entire cohort was 0.45 ± 0.03. The mean (± SD) age for the 8-week treatment was 69.7 (± 7) years, 54.7% male and 45.3% female. The mean (± SD) age of the 12-week treatment was 71.7 (± 3) years, 56.4% male and 43.6% female. Overall, SVR-12 for the 8-week regimen was 93% and SVR-12 for the 12-week regimen was 95%. For the 182 treated with the 8-week LDV/SOF treatment, there were no serious adverse events requiring hospitalization or signs of liver failure requiring transplantation. Overall, the 8-week treatment patient cohort experienced less fatigue, headache, dry mouth, and diarrhea. This finding was statistically significant with a P value < 0.001. CONCLUSION: Eight-week LDV/SOF therapy in treatment-naive, non-cirrhotic, genotype 1 HCV patients with RNA < 6 million IU/mL was found safe, better tolerated, effective, and required less upfront cost when compared with the 12-week LDV/SOF treatment regimen in properly selected geriatric population.
AIM: Results of recent studies have confirmed the efficacy of an 8-week course of ledipasvir/sofosbuvir (LDV/SOF) in patients who are non-cirrhotics, native to treatment, are infected with hepatitis C (HCV) genotype 1, and have HCV viral load < 6 million IU/mL. However, there are limited data on a shortened treatment course in patients who are over the age of 65. METHODS: A retrospective study was performed to examine the safety, tolerability, and sustained viral response rates (SVR) of the 8-week LDV/SOF therapy compared to the 12-week LDV/SOF therapy among non-cirrhotic, treatment-naïve, genotype 1 HCV patients with viral load < 6 million IU/mL who are 65 years of age or older. RESULTS: A total of 454 patients were identified of which 182 non-cirrhotic, genotype 1 HCV-RNA < 6 million IU/mL patients received the 8-week LDV/SOF treatment and 272 received the 12-week LDV/SOF treatment. Mean [± standard deviation (SD)] aspartate aminotransferase to platelet ratio index score for the entire cohort was 0.45 ± 0.03. The mean (± SD) age for the 8-week treatment was 69.7 (± 7) years, 54.7% male and 45.3% female. The mean (± SD) age of the 12-week treatment was 71.7 (± 3) years, 56.4% male and 43.6% female. Overall, SVR-12 for the 8-week regimen was 93% and SVR-12 for the 12-week regimen was 95%. For the 182 treated with the 8-week LDV/SOF treatment, there were no serious adverse events requiring hospitalization or signs of liver failure requiring transplantation. Overall, the 8-week treatment patient cohort experienced less fatigue, headache, dry mouth, and diarrhea. This finding was statistically significant with a P value < 0.001. CONCLUSION: Eight-week LDV/SOF therapy in treatment-naive, non-cirrhotic, genotype 1 HCV patients with RNA < 6 million IU/mL was found safe, better tolerated, effective, and required less upfront cost when compared with the 12-week LDV/SOF treatment regimen in properly selected geriatric population.
Authors: Kris V Kowdley; Stuart C Gordon; K Rajender Reddy; Lorenzo Rossaro; David E Bernstein; Eric Lawitz; Mitchell L Shiffman; Eugene Schiff; Reem Ghalib; Michael Ryan; Vinod Rustgi; Mario Chojkier; Robert Herring; Adrian M Di Bisceglie; Paul J Pockros; G Mani Subramanian; Di An; Evguenia Svarovskaia; Robert H Hyland; Phillip S Pang; William T Symonds; John G McHutchison; Andrew J Muir; David Pound; Michael W Fried Journal: N Engl J Med Date: 2014-04-10 Impact factor: 91.245
Authors: Nezam Afdhal; Stefan Zeuzem; Paul Kwo; Mario Chojkier; Norman Gitlin; Massimo Puoti; Manuel Romero-Gomez; Jean-Pierre Zarski; Kosh Agarwal; Peter Buggisch; Graham R Foster; Norbert Bräu; Maria Buti; Ira M Jacobson; G Mani Subramanian; Xiao Ding; Hongmei Mo; Jenny C Yang; Phillip S Pang; William T Symonds; John G McHutchison; Andrew J Muir; Alessandra Mangia; Patrick Marcellin Journal: N Engl J Med Date: 2014-04-11 Impact factor: 91.245
Authors: David Wyles; Hadas Dvory-Sobol; Evguenia S Svarovskaia; Brian P Doehle; Ross Martin; Nezam H Afdhal; Kris V Kowdley; Eric Lawitz; Diana M Brainard; Michael D Miller; Hongmei Mo; Edward J Gane Journal: J Hepatol Date: 2016-12-05 Impact factor: 25.083
Authors: Massimo Giuseppe Colombo; Erkin Isakovich Musabaev; Umed Yusupovich Ismailov; Igor A Zaytsev; Alexander V Nersesov; Igor Anatoliyevich Anastasiy; Igor Alexandrovich Karpov; Olga A Golubovska; Kulpash S Kaliaskarova; Ravishankar Ac; Sanjay Hadigal Journal: World J Gastroenterol Date: 2019-08-07 Impact factor: 5.742