P0849 : Real-world effectiveness of sofosbuvir (SOF), telaprevir, and boceprevir (T, B) based therapy for hepatitis C virus (HCV): An analysis in a large integrated health care system

POSTERS P0849 REAL-WORLD EFFECTIVENESS OF SOFOSBUVIR (SOF), TELAPREVIR, AND BOCEPREVIR (T, B) BASED THERAPY FOR HEPATITIS C VIRUS (HCV): AN ANALYSIS IN A LARGE INTEGRATED HEALTH CARE SYSTEM J.B. Lai1 , D.J. Witt1 , M.A. Witt1 . 1 Infectious Disease, Kaiser Permanente Medical Center, San Rafael, United States E-mail: [email protected] Background and Aims: New direct-acting antiviral (DAA) agents have become an integral component of treatment for HCV infection but little is known about their real-world effectiveness particularly in community practice. To optimize therapy, Kaiser Permanente Northern California (KPNC) established an HCV care team at each of 21 medical centers, which included a Gastroenterologist or Infectious Disease specialist, Clinical Pharmacist, Nurse and Hepatologist at each medical center. We compared virologic responses of patients receiving DAA-based therapy to those reported in clinical trials, including FDA approval documents. Methods: Approval was obtained from the KPNC Institutional Review Board. HCV patients who completed T or B by 30AUG13 or SOF [with ribavirin (RBV) for genotype (GT) 2 or PEG-interferon (PEG-IFN)/RBV for non-GT2] based therapy by 30SEP14 were identified and analyzed on an intent-to-treat basis. Sustained viral response 12 (SVR12) was defined as undetectable (UD) HCV RNA 12 weeks after completing therapy. Results: For GT1 treatment naïve (TN) patients treated with SOF/PEG-IFN/RBV, we found an SVR12 of 73.3%. For GT2 TN with SOF/RBV, we found the SVR12 was 92.6%. For GT1 with T/PEGIFN/RBV, we found SVR12’s of 65% and 59%, for TN and treatment experienced (TE), respectively, and for GT1 with B/PEG-IFN/RBV, the SVR12’s were 56% and 61%, for TN and TE, respectively. Detailed results and comparisons to published clinical trials are located in Figure 1. Conclusions: Our purely community-based results were similar to those observed in randomized controlled trials and included comparisons of the more difficult to tolerate interferon-based regimens. We believe our multidisciplinary care team provided a similar framework to the intense support often provided in clinical trials.

P0850 PERCENT OF SUBJECTS EXPERIENCING LIVER MORBIDITY OVER A LIFETIME HORIZON WITH ABBVIE 3D (ABT-450/RITONAVIR/ OMBITASVIR AND DASABUVIR) VERSUS NO TREATMENT S.J. Johnson1 , H. Parise´ 1 , S. Virabhak1 , D.A. Misurski2 , T.R. Juday2 , J.C. Samp2,2,2 , S.E. Marx2 , S. Saab3 . 1 Medicus Economics, Milton, 2 Global Health Economics and Outcomes Research, AbbVie, Mettawa, 3 Pfleger Liver Institute, Los Angeles, United States E-mail: [email protected] Background and Aims: Treating and curing patients with hepatitis C virus (HCV) is associated with reductions in long-term morbidity. Additionally, earlier HCV treatment is thought to reduce morbidity compared to treatment of HCV in later disease stages. Newer therapies for HCV are available that offer substantially improved sustained virologic response (SVR) rates. It is unclear what the impact these drugs will be on long-term morbidity and mortality. The aim of this study was to compare liver disease morbidity rates for HCV patients in varying disease stages who are treated with AbbVie 3D (ABT-450/ritonavir/ombitasvir and dasabuvir) +/− ribavirin compared to no treatment. Methods: A Markov health state model estimated lifetime outcomes for patients treated with the AbbVie 3D regimen and no treatment. The model had 13 states including 8 disease progression states (F0–F4, decompensated cirrhosis [DCC], hepatocellular carcinoma [HCC], and liver transplant [LT]), 3 SVR states (based on baseline fibrosis score), and 2 mortality states (liver-related and non-liver-related death). Transition rates were derived from previous models. Population characteristics and efficacy rates were based on the AbbVie 3D phase 3 clinical trials. The model was run over a lifetime horizon. Analyses were run separately for each fibrosis score and for treatment naïve and treatment experienced patients. Rates of DCC, HCC, and LT were analyzed. Results: Lower rates of DCC, HCC, and LT were seen across all fibrosis stages (F0–F4) in HCV patients treated with AbbVie 3D compared to no treatment (Table 1). Rates were 5 to 7 fold lower in the treated HCV patients compared to untreated patients, with an except in HCC among the F4 patients (e.g., 28.5% versus 28.9% for untreated and treated naïve patients, respectively). Rates of HCC were similar between the treated and untreated F4 patients likely due to the excess risk of HCC that remains for compensated patients despite viral clearance. Morbidity rates were similar among treatment naïve and treatment experienced patients of the same disease stage and rates of morbidity rose with increasing baseline disease severity. Conclusions: The percent of HCV patients experiencing liver morbidity – DCC, HCC, and LT – was significantly reduced with AbbVie 3D treatment compared to HCV patients who were not treated. Rates of morbidity were higher when treatment was deferred to patients with greater baseline disease severity. Table 1. Percent of subjects experiencing liver morbidity over a lifetime horizon with AbbVie 3D versus no treatment Fibrosis stage

Liver morbidity Decompensated cirrhosis

Hepatocellular carcinoma

Liver transplant

No treatment

AbbVie 3D

No treatment

No treatment

AbbVie 3D

AbbVie 3D

Treatment naive

Figure 1.

F0 (100%)

18.2%

2.9%

10.0%

1.6%

4.0%

0.6%

F1 (100%)

26.0%

4.4%

14.3%

2.4%

5.9%

0.9%

F2 (100%)

33.4%

6.0%

18.5%

3.3%

7.8%

1.3%

F3 (100%)

41.7%

7.9%

23.1%

4.3%

10.1%

1.8%

F4 (100%)

51.2%

9.7%

28.5%

28.9%

12.8%

6.8%

Treatment experienced

S658

F0 (100%)

17.6%

2.6%

9.6%

1.4%

3.8%

0.5%

F1 (100%)

25.1%

3.9%

13.8%

2.1%

5.6%

0.8%

F2 (100%)

32.3%

5.3%

17.9%

2.9%

7.5%

1.2%

F3 (100%)

40.4%

7.1%

22.4%

3.9%

7.9%

1.6%

F4 (100%)

49.7%

8.5%

27.7%

27.4%

12.3%

6.3%

Journal of Hepatology 2015 vol. 62 | S263–S864