Poster Round-Up: Clinical and Managed Care Outcomes

As the third day of The Liver Meeting 2014 dawns, a pattern is emerging in the hepatitis C virus (HCV) treatment realm—of the newly approved agents, the sofosbuvir (SOF)-simeprevir (SMV)-based regimens are gaining traction. A poster session on Approved Therapeutic Agents on November 9, 2014, at the annual meeting of the American Association for the Study of Liver Disease (AASLD), proved this yet again.

In a multi-center phase 2 study, SOF/SIM + ribavirin (RBV) led to high sustained virologic response (SVR) in genotype 1 (GT1)-infected patients. This study was highlighted by the president of AASLD, Adrian M. Di Bisceglie, MD, FACP, FAASLD, professor of internal medicine and chairman of the Department of Internal Medicine at Saint Louis University in Missouri, during a press conference held the evening of November 8, 2014. This regimen, which was previously recommended by AASLD/IDSA guidelines for certain clinical settings,¹ and has been commonly used off-label, was approved by the FDA just this week.²

The poster presented results of HCV-TARGET (HCVT), a longitudinal observational study of patients treated with direct-acting antivirals (DAAs) at academic (43) and community medical centers (13) in North America (51) and Europe (5). HCVT employs a unique centralized data abstraction core along with independent data monitors, who systematically review data entries for completeness and accuracy. Demographic, clinical, adverse events, and virological data are collected throughout treatment and post-treatment follow-up from enrolled patients.

HCV target obtained consent from 2339 patients, of whom 2063 have initiated treatment till date and were included in the analysis, according to the data presented at the meeting. The results showed that 989 of 1453 patients with GT1 (68%) were treated with SOF/SIM, with (217 patients, 22%) or without RBV (772, 78%). Of the 989 who were treated, 57% were cirrhotic and 60% had failed prior HCV treatment. The following SVR data were presented:

Regimen

SVR12

GT1

SOF/SMV ± RBV

SVR4

Yes

No

Yes

143

4

No

0

37

The trial has not experienced any unexpected adverse events so far and the authors conclude that the SOF/SIM combination is well-tolerated among their patient cohort. SVR4 was achieved in 86% to 87% of patients; while SVR4 rates were similar based on RBV use, they were lower in patients with decompensated cirrhosis with GT1a and prior protease inhibitor triple therapy, the authors conclude.

Trio Health is a disease management platform that includes academic medical centers and community physicians in partnership with specialty pharmacies, and is used to deliver optimal care for HCV with a managed adherence and compliance program. Since January 2014, Trio has been managing over 6000 HCV patients. This real life cohort permits exploration of responses to treatment in previously poorly studied groups such as interferon (IFN) and RBV treatment failures, who were not studied in phase 3 programs for either SOF or SMV).

The Trio health platform was used to evaluate SVR in patients with GT1 who were prior treatment failures to an IFN-based regimen in a real life setting. The company’s database was used to identify all GT1 patients who were included in the outcomes data cohort that were prior IFN treatment failures and who started medication prior to April 1, 2014. Four hundred and seven patients were identified, with 76% from academic centers and 24% from community practices. Of these 407 treatment-experienced GT1 patients, analysis was limited to 332 for a 2-week regimen. Of the 407 patients, 75 were on a >12-week regimen. Among the 332 who were on a 12-week regimen, 6 were lost to follow-up, 19 discontinued, and 307 completed treatment. Forty-four of the 307 have SVR pending and SVR12 was not achieved in 45 patients. Of the intent-to-treat (ITT) population, 76% achieved SVR12, while in the per protocol (PP) population, 83% achieved SVR12.

The till-date statistics presented for this study indicated that 98% of the retrospective study population received a SOF-based regimen, and 50% received SOF/SIM treatment. Based on regimen, SVR12 was 72% ITT and 78% PP for pegylated-IFN + RBV + SOF, while it was 81% ITT and 87% for SMV + SOF ± RBV.

References

1. AASLD/IDSA hepatitis C guidance: managed care pharmacy considerations and perspectives. http://www.amcpmeetings.org/past/2014spring/handouts/spcpdf/05.pdf. Published April 1, 2014. Accessed November 9, 2014.
2. OLYSIO® (simeprevir) gains additional FDA approval as once-daily, all-oral interferon- and ribavirin-free treatment option in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C infection [press release]. Janssen Therapeutics; Titusville, NJ: November 5, 2014. http://www.investor.jnj.com/releaseDetail.cfm?ReleaseID=881192&year=2014.