Adeel A Butt1,2,3,4, Peng Yan1, Obaid S Shaikh1,4, Raymond T Chung5,6, Kenneth E Sherman7. 1. VA Pittsburgh Healthcare System, Pittsburgh, PA, USA. 2. Hamad Healthcare Quality Institute, Doha, Qatar. 3. Hamad Medical Corporation, Doha, Qatar. 4. University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. 5. Massachusetts General Hospital, Boston, MA, USA. 6. Harvard Medical School, Boston, MA, USA. 7. University of Cincinnati College of Medicine/UC Health, Cincinnati, OH, USA.
Abstract
BACKGROUND & AIMS: Sofosbuvir is widely prescribed for treatment of HCV infection. We compared the sustained virologic response rates (SVR12) and the haematologic toxicity of various sofosbuvir-based regimens in routine clinical practice. METHODS: We used ERCHIVES (Electronically Retrieved Cohort of HCV infected Veterans) to identify HCV-infected persons initiated on sofosbuvir-based regimens. Treatment duration and regimen were defined as per labelling guidelines. We excluded persons with HIV, positive hepatitis-B surface antigen, hepatocellular carcinoma and missing HCV RNA. RESULTS: Among 4257 sofosbuvir-treated persons, sofosbuvir/simeprevir (30%), sofosbuvir/ledipasvir (29%) and sofosbuvir/ribavirin (23%) were the most common combinations prescribed. The mean age (SD) was 60.22 (6.3) years, 96% were male, 22.4% were black, 37.2% had cirrhosis, 29.7% were treatment-experienced; baseline mean HCV RNA was 6.73 log lIU/ml. Comorbidities included: 40.2% alcohol abuse or dependence, 39.7% drug abuse or dependence, 25.1% diabetes and 14.4% stage 3-5 chronic kidney disease. Overall, 86.7% completed a full course of treatment. Overall, SVR12 rates were 88-98% in the sofosbuvir/simeprevir group and 93-98% in the sofosbuvir/ledipasvir group and did not vary based on previous treatment history or cirrhosis at baseline. For genotype 2/3 patients treated with sofosbuvir/ribavirin, SVR12 rates ranged from 69 to 87% with lowest rates in treatment-experienced cirrhotics. For the sofosbuvir/simeprevir and sofosbuvir/ledipasvir groups, grade3/4 haematologic adverse events were uncommon; these trended back close to baseline values after completion of treatment. CONCLUSIONS: Sofosbuvir-based regimens in clinical practice are associated with SVR rates comparable to those seen in clinical trials and low rates of grade 3/4 haematological adverse events.
BACKGROUND & AIMS:Sofosbuvir is widely prescribed for treatment of HCV infection. We compared the sustained virologic response rates (SVR12) and the haematologic toxicity of various sofosbuvir-based regimens in routine clinical practice. METHODS: We used ERCHIVES (Electronically Retrieved Cohort of HCV infected Veterans) to identify HCV-infectedpersons initiated on sofosbuvir-based regimens. Treatment duration and regimen were defined as per labelling guidelines. We excluded persons with HIV, positive hepatitis-B surface antigen, hepatocellular carcinoma and missing HCV RNA. RESULTS: Among 4257 sofosbuvir-treated persons, sofosbuvir/simeprevir (30%), sofosbuvir/ledipasvir (29%) and sofosbuvir/ribavirin (23%) were the most common combinations prescribed. The mean age (SD) was 60.22 (6.3) years, 96% were male, 22.4% were black, 37.2% had cirrhosis, 29.7% were treatment-experienced; baseline mean HCV RNA was 6.73 log lIU/ml. Comorbidities included: 40.2% alcohol abuse or dependence, 39.7% drug abuse or dependence, 25.1% diabetes and 14.4% stage 3-5 chronic kidney disease. Overall, 86.7% completed a full course of treatment. Overall, SVR12 rates were 88-98% in the sofosbuvir/simeprevir group and 93-98% in the sofosbuvir/ledipasvir group and did not vary based on previous treatment history or cirrhosis at baseline. For genotype 2/3 patients treated with sofosbuvir/ribavirin, SVR12 rates ranged from 69 to 87% with lowest rates in treatment-experienced cirrhotics. For the sofosbuvir/simeprevir and sofosbuvir/ledipasvir groups, grade3/4 haematologic adverse events were uncommon; these trended back close to baseline values after completion of treatment. CONCLUSIONS:Sofosbuvir-based regimens in clinical practice are associated with SVR rates comparable to those seen in clinical trials and low rates of grade 3/4 haematological adverse events.
Authors: Adeel A Butt; Peng Yan; Kara W Chew; Judith Currier; Kathleen Corey; Raymond T Chung; Ashfaq Shuaib; Abdul-Badi Abou-Samra; Javed Butler; Matthew S Freiberg Journal: Clin Infect Dis Date: 2017-08-15 Impact factor: 9.079
Authors: Christina Yek; Carolina de la Flor; John Marshall; Cindy Zoellner; Grace Thompson; Lisa Quirk; Christian Mayorga; Barbara J Turner; Amit G Singal; Mamta K Jain Journal: BMC Med Date: 2017-11-20 Impact factor: 8.775