BACKGROUND: The HIVCOBOC-RGT study (NCT01925183) was the first study to evaluate response-guided shortening of the duration of boceprevir (BOC)-based triple therapy in human immunodeficiency virus (HIV)/hepatitis C virus genotype 1-coinfected patients (HIV/HCV-GT1). METHODS: After 4 weeks of pegylated interferon-α-2a/ribavirin (PEGIFN/RBV) lead-in, patients with target-not-detectable HCV-RNA at week 8 (rapid virologic response; LI4W-W8UTND) received 24 weeks of BOC/PEGIFN/RBV (total: 28 weeks [W28]). Patients with target-detectable HCV-RNA at week 8 received 44 weeks of BOC/PEGIFN/RBV (total: 48 weeks [W48]). RESULTS: Fourteen patients (67%) had LI4W-W8UTND and were eligible for the shortened W28 arm, while 7 (33%) patients were allocated to the W48 arm. No breakthrough or relapse occurred in the W28 arm, resulting in a sustained virologic response (SVR12TND) rate of 100% (12/12). In the W48 arm, the SVR12TND was 50% (3/6), with 3 patients meeting the futility rule at treatment week 12. The preliminary overall SVR12TND rate was 83% (15/18). Serious adverse events were observed in 5 (24%) patients, with 2 (10%) patients requiring surgical treatment of abscesses. CONCLUSIONS: The majority of HIV/HCV-GT1 were eligible for response-guided shortening of treatment duration to W28 and all of these patients had a SVR12TND. If second-generation direct-acting antivirals are not available, W28 of BOC-based triple therapy may be recommended.
BACKGROUND: The HIVCOBOC-RGT study (NCT01925183) was the first study to evaluate response-guided shortening of the duration of boceprevir (BOC)-based triple therapy in human immunodeficiency virus (HIV)/hepatitis C virus genotype 1-coinfectedpatients (HIV/HCV-GT1). METHODS: After 4 weeks of pegylated interferon-α-2a/ribavirin (PEGIFN/RBV) lead-in, patients with target-not-detectable HCV-RNA at week 8 (rapid virologic response; LI4W-W8UTND) received 24 weeks of BOC/PEGIFN/RBV (total: 28 weeks [W28]). Patients with target-detectable HCV-RNA at week 8 received 44 weeks of BOC/PEGIFN/RBV (total: 48 weeks [W48]). RESULTS: Fourteen patients (67%) had LI4W-W8UTND and were eligible for the shortened W28 arm, while 7 (33%) patients were allocated to the W48 arm. No breakthrough or relapse occurred in the W28 arm, resulting in a sustained virologic response (SVR12TND) rate of 100% (12/12). In the W48 arm, the SVR12TND was 50% (3/6), with 3 patients meeting the futility rule at treatment week 12. The preliminary overall SVR12TND rate was 83% (15/18). Serious adverse events were observed in 5 (24%) patients, with 2 (10%) patients requiring surgical treatment of abscesses. CONCLUSIONS: The majority of HIV/HCV-GT1 were eligible for response-guided shortening of treatment duration to W28 and all of these patients had a SVR12TND. If second-generation direct-acting antivirals are not available, W28 of BOC-based triple therapy may be recommended.
Authors: Mattias Mandorfer; Philipp Schwabl; Sebastian Steiner; Thomas Reiberger; Markus Peck-Radosavljevic Journal: Hepatol Int Date: 2016-01-12 Impact factor: 6.047
Authors: Mattias Mandorfer; Sebastian Steiner; Philipp Schwabl; Berit A Payer; Maximilian C Aichelburg; Katharina Grabmeier-Pfistershammer; Michael Trauner; Thomas Reiberger; Markus Peck-Radosavljevic Journal: Wien Klin Wochenschr Date: 2015-12-10 Impact factor: 1.704
Authors: Karin Neukam; Daniela I Munteanu; Antonio Rivero-Juárez; Thomas Lutz; Jan Fehr; Mattias Mandorfer; Sanjay Bhagani; Luis F López-Cortés; Annette Haberl; Marcel Stoeckle; Manuel Márquez; Stefan Scholten; Ignacio de Los Santos-Gil; Stefan Mauss; Antonio Rivero; Antonio Collado; Marcial Delgado; Juergen K Rockstroh; Juan A Pineda Journal: PLoS One Date: 2015-04-29 Impact factor: 3.240
Authors: Bernhard Scheiner; Philipp Schwabl; Sebastian Steiner; Theresa Bucsics; David Chromy; Maximilian C Aichelburg; Katharina Grabmeier-Pfistershammer; Michael Trauner; Markus Peck-Radosavljevic; Thomas Reiberger; Mattias Mandorfer Journal: Medicine (Baltimore) Date: 2016-07 Impact factor: 1.889