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Interferon-free treatment with sofosbuvir/daclatasvir achieves sustained virologic response in 100% of HIV/hepatitis C virus-coinfected patients with advanced liver disease

Mandorfer, Mattias; Schwabl, Philipp; Steiner, Sebastian; Scheiner, Bernhard; Chromy, David; Bucsics, Theresa; Stättermayer, Albert Friedrich; Aichelburg, Maximilian Christopher; Grabmeier-Pfistershammer, Katharina; Trauner, Michael; Reiberger, Thomas; Peck-Radosavljevic, Markus

doi: 10.1097/QAD.0000000000001020
Clinical Science

Aim: We aimed to investigate the safety and efficacy of interferon (IFN) and ribavirin (RBV)-free therapy with sofosbuvir along with daclatasvir (SOF/DCV) in HIV/hepatitis C virus (HCV)-coinfected patients (HIV/HCV), who have an urgent need for effective antiviral therapy. We also assessed its impact on liver stiffness and liver enzymes.

Design: Thirty-one patients thoroughly documented HIV/HCV with advanced liver disease (advanced liver fibrosis and/or portal hypertension) who were treated with SOF/DCV were retrospectively studied.

Methods: The following treatment durations were applied: HCV-genotype (HCV-GT)1/4 without cirrhosis: 12 weeks; HCV-GT1/4 with cirrhosis: 24 weeks; HCV-GT3: 24 weeks; if HCV-RNA was detectable 4 weeks before the end of treatment, treatment was extended by 4 weeks at a time.

Results: Fifty-two percent of patients were treatment-experienced. The majority of patients had HCV-GT1 (68%), whereas HCV-GT3 and HCV-GT4 were observed in 23 and 10% of patients, respectively. Ninety-four percent had liver stiffness greater than 9.5 kPa or METAVIR fibrosis stage higher than F2 and 45% had liver stiffness above 12.5 kPa or METAVIR F4. Portal hypertension (HVPG ≥6 mmHg) and clinically significant portal hypertension (HVPG ≥10 mmHg) were observed in 67% (18/27) and 26% (7/27) of patients, respectively. Sustained virologic response 12 weeks after the end of treatment (SVR12) was achieved in 100% (31/31). Treatment with SOF/DCV was generally well tolerated and there were no treatment discontinuations. HCV eradication improved liver stiffness from 11.8 [interquartile range (IQR): 11.5 kPa] to 6.9 (IQR: 8.2) kPa [median change: –3.6 (IQR:5.2) kPa; P < 0.001] and decreased liver enzymes. The mean time period between treatment initiation and follow-up liver stiffness measurement was 32.7 ± 1.2 weeks.

Conclusion: IFN- and RBV-free treatment with SOF/DCV was well tolerated and achieved SVR12 in all HIV/HCV with advanced liver disease. It also significantly improved liver stiffness, suggesting anti-fibrotic and anti-portal hypertensive effects.

aDivision of Gastroenterology and Hepatology, Department of Internal Medicine III

bDivision of Immunology, Allergy and Infectious Diseases, Department of Dermatology, Medical University of Vienna

cVienna HIV and Liver Study Group, Vienna, Austria.

Correspondence to Markus Peck-Radosavljevic, MD, Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. Tel: +43 1 40400 47440; fax: +43 1 40400 47350; e-mail: markus.peck@meduniwien.ac.at

Received 1 November, 2015

Revised 1 January, 2016

Accepted 4 January, 2016

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