Interferon and ribavirin-free therapy with sofosbuvir and daclatasvir in a real-life cohort of difficult-to-treat HIV/HCV-coinfected patients

M Mandorfer; S Steiner; P Schwabl; MC Aichelburg; K Grabmeier-Pfistershammer; A Rieger; M Trauner; T Reiberger; M Peck-Radosavljevic

doi:10.1055/s-0035-1551747

Zeitschrift für Gastroenterologie, Table of Contents

Interferon and ribavirin-free therapy with sofosbuvir and daclatasvir in a real-life cohort of difficult-to-treat HIV/HCV-coinfected patients

M Mandorfer ¹, S Steiner ¹, P Schwabl ¹, MC Aichelburg ¹, K Grabmeier-Pfistershammer ¹, A Rieger ¹, M Trauner ¹, T Reiberger ¹, M Peck-Radosavljevic ¹

¹Vienna HIV & Liver Study Group, Medical University of Vienna, Vienna, Austria

Abstract

Background: Despite promising results for the combination of sofosbuvir and daclatasvir (SOF/DCV) in patients with HCV-monoinfection, there are currently no reports on its use in HIV/HCV-coinfected patients (HIV/HCV).

Aim: To investigate the use of SOF/DCV in HIV/HCV, who have an urgent need for effective treatment options.

Methods: The DCV dose was adjusted to the antiretroviral therapy, as recommended by the European label. The following treatment durations were applied: HCV-genotype (HCV-GT)1/4 with cirrhosis and HCV-GT3: 24 weeks; HCV-GT1/4 without cirrhosis: 12 weeks; if HCV-RNA was detectable 4 weeks before the end of treatment, treatment was extended by 4 weeks at a time. HCV-RNA was assessed using the Abbott RealTime HCV assay (lower limit of quantification and detection 12IU/mL).

Results: 14 (45%) patients were treatment experienced, including 3 (10%) patients with previous HCV protease inhibitor failure. The majority of patients had HCV-GT1 (1a: 18 [58%]; 1b: 3 [10%]), while HCV-GT3 and HCV-GT4 were observed in 7 (23%) and 3 (10%) patients, respectively. All patients had F3 fibrosis (14[45%]), cirrhosis (14[45%]), or an extrahepatic manifestation of CHC (3[10%]). These were cryoglobulinemia with leg ulcers, cryoglobulinemia with glomerulonephritis and end stage renal disease, as well as primary central nervous system lymphoma. Median liver stiffness values were 10.2 (5.2)kPa and 10.5 (9.3)kPa in the overall study population and in the subgroup of patients with information on HVPG (n = 22), respectively. The mean hepatic venous

pressure gradient was 8.2 ± 4.2 mmHg. Portal hypertension (HVPG≥6 mmHg) and clinically significant portal hypertension (CSPH; HVPG≥10 mmHg) were observed in 16 (73%) and 8 (36%) patients, respectively.

Conclusions: Results from our thoroughly documented real-life cohort including patients with cirrhosis and CSPH or extrahepatic manifestations will provide important evidence for the use of SOF/DCV in this special population.

The results will be updated prior to the presentation at the meeting to include additional patients as well as on-treatment and preliminary sustained virologic response rates.