Background: Pharmaceutical costs-per-sustained virologic response (SVR4) were determined for patients treated with simeprevir (SMV) and sofosbuvir (SOF) at a large metropolitan medical center.
Methods: The SVR4 rate was calculated for 103 genotype 1 HCV-infected patients who started on SMV- SOF-containing regimens between 12/2013-6/2014. Advanced fibrosis/cirrhosis was defined as a FIB-4 score ≥ 3.25. Costs were based on Red Book Wholesale Acquisition Costs and the number of days on treatment: SMV=$790/d, SOF =$1,000/d, and RBV=$8.58/d. The rate of relapse between 4 and 12 weeks after the end of treatment (EOT) was determined for 41 patients with the necessary follow up data. Episodes of hepatic decompensation and other serious adverse events (SAEs) were noted.
Results: The median age of the 103 patients was 60 years (interquartile range [IQR] = 54-65 years), 14% had HIV/HCV co-infection, 13% were black, 74% were male, 46% had a score ≥ 3.25; 74% had genotype 1a HCV, 25% were naïve to treatment, 28% previously failed therapy with an HCV protease inhibitor. Median baseline laboratory values were as follows: platelet count = 154 x103/µL (IQR: 111-194 x103/µL), albumin = 4.1 g/dL (IQR: 3.8-4.4 g/dL), total bilirubin = 0.7 mg/dL (IQR: 0.5 – 1.0 mg/dL), median log HCV viral load = 6.25 IU/mL (IQR: 5.90 – 6.72 IU/mL). The treatment completion rate for the entire group was 98%, see Table. Overall, 93 (90%) achieved SVR4: SMV/SOF/RBV 77/85 (91%), SMV/SOF 16/18 (89%). Three (2.9%) patients experienced hepatic decompensation/SAE. The SVR4 rates for mono-infected and HIV/HCV patients were 89% and 100% (p=0.35), respectively. The overall mean pharmaceutical cost-per-SVR4 was $164,485. Among 41 patients with the necessary follow up, three (7%) relapsed between week-4 and week-12 post EOT.
Conclusions: In the SMV/SOF era, 98% of patients completed the planned regimen in real world clinical practice. The SVR4 rate was 90% and the mean pharmaceutical cost-per-SVR4 was $164,485. Treatment was highly effective in patients with HIV/HCV co-infection. Rates of decompensation/SAE were < 3%. Surveillance beyond SVR4 is needed to determine the final SVR rate. Seven percent of patients with follow up data relapsed between 4 and 12 weeks EOT.
| Regimen (duration of treatment) | N | FIB-4 ^ 3.25 | Previous protease inhibitor failure | Completed therapy | Serious adverse event or hepatic decompensation | SVR4 rate | Mean cost per SVR4 |
| SOF/SMV/RBV (12 weeks) | 85 | 43 (51%) | 27 (32%) | 84 (99%) | 0 (0%) | 77 (91%) | $165,142 |
| SOF/SMV (12 weeks) | 18 | 6 (33%) | 2 (11%) | 17 (94%) | 3 (17%) | 16 (89%) | $161,323 |
| Total | 103 | 2 (11%) | 29 (28%) | 101 (98%) | 3 (2.9%) | 93 (90%) | $164,485 |