Background and AimTo investigate the impact of a sustained virological response (SVR) to hepatitis C virus (HCV) treatment on liver stiffness (LS).MethodsLS, measured by transient elastography (FibroScan), demographic and laboratory data of patients treated with interferon (IFN)-containing or IFN-free regimens who had an SVR24 (undetectable HCV viral load 24 weeks after the end of treatment) were analyzed using two-tailed paired t-tests, Mann-Whitney Wilcoxon Signed-rank tests and linear regression. Two time intervals were investigated: pre-treatment to SVR24 and SVR24 to the end of follow-up. LS scores ≥ 12.5 kPa indicated LS-defined cirrhosis. A p-value below 0.05 was considered statistically significant.ResultsThe median age of the patients (n = 100) was 60 years [IQR (interquartile range) 54–64); 72% were male; 60% were Caucasian; and 42% had cirrhosis pre-treatment according to the FibroScan measurement. The median LS score dropped from 10.40 kPa (IQR: 7.25–18.60) pre-treatment to 7.60 kPa (IQR: 5.60–12.38) at SVR24, p <0.01. Among the 42 patients with LS-defined cirrhosis pre-treatment, 25 (60%) of patients still had LS scores ≥ 12.5 kPa at SVR24, indicating the persistence of cirrhosis. The median change in LS was similar in patients receiving IFN-containing and IFN-free regimens: -1.95 kPa (IQR: -5.75 –-0.38) versus -2.40 kPa (IQR: -7.70 –-0.23), p = 0.74. Among 56 patients with a post-SVR24 LS measurement, the LS score changed by an additional -0.90 kPa (IQR: -2.98–0.5) during a median follow-up time of 1.17 (IQR: 0.88–1.63) years, which was not a statistically significant decrease (p = 0.99).ConclusionsLS decreased from pre-treatment to SVR24, but did not decrease significantly during additional follow-up. Earlier treatment may be needed to reduce the burden of liver disease.

Introduction In registration trials, triple therapy with telaprevir (TVR), pegylated-interferon (IFN), and ribavirin (RBV) achieved sustained virological response (SVR) rates between 64–75%, but the clinical effectiveness and economic burdens of this treatment in real-world practice remain to be determined. Methods Records of 147 patients who initiated TVR-based triple therapy at the Mount Sinai Medical Center (5/2011–12/2011) were reviewed. Direct medical costs for pre-treatment, on-treatment, and post-treatment care were calculated using data from Medicare reimbursement databases, RED Book, and Healthcare Cost and Utilization Project database. Costs are presented in 2012 US dollars. SVR (undetectable HCV RNA 24 weeks after the end-of-treatment) was determined on an intention-to-treat basis. Cost-per-SVR was calculated by dividing the median cost by the SVR rate. Results Median age of the 147 patients was 56 years [interquartile range (IQR) = 51 – 61], 68% were male, 19% were black, 11% had HIV/HCV co-infection, 36% had advanced fibrosis/cirrhosis (FIB-4 scores ≥ 3.25), 44% achieved an SVR. The total cost of care was $11.56 million. Median cost of care was $83,721 per patient (IQR=$66,652– $98,102). The median cost-per-SVR was $189,338 (IQR=$150,735 – $221,860). Total costs were TVR (61%), IFN (24%), RBV (4%), adverse event management (8%), professional fees (2%), and laboratory tests (1%). Conclusions TVR and IFN accounted for 85% of costs. Pharmaceutical prices and the low (44%) SVR rate, in this real-world study, were major contributors to the high cost-per-SVR.

The high burden of HBV infection among African immigrants in the United States underscores a need for continued screening and linkage to care in this at-risk population.

SMV/SOF ± RBV is an effective option with minimal adverse effects for most HIV-positive patients with genotype 1 HCV. SMV should be used with caution in patients with decompensated cirrhosis.

HIV providers ordered significantly fewer HCC screening and HBV monitoring tests than hepatologists within a single academic medical center. In the setting of increased reliance on quality indicators for care, both patients and providers will benefit from greater adherence to established guidelines.

Objectives Vulnerable, urban populations with a history of substance use disorders have a high prevalence of hepatitis C virus (HCV). Primary care-based treatment has been proposed to improve access to care. In this study, we present outcomes from our urban, primary care-based HCV treatment program in patients treated with telaprevir or boceprevir in combination with pegylated-interferon and ribavirin (‘‘triple therapy’’). Methods We collected data from 126 consecutive patients with genotype 1 HCV monoinfection seen in our treatment program (2011–2013). Among the 40 who initiated treatment, we analyzed factors associated with achieving a sustained viral response (SVR). Results During the study period, 40 patients initiated triple therapy (32%), 80% with recent or past substance use disorders. Patients initiating treatment were younger than untreated patients (P = 0.002), but otherwise did not differ demographically, or in the severity of their liver fibrosis (P >0.05). An SVR was achieved in 18 patients (45%) and was less likely in patients with recent or past substance use disorders or psychiatric illness (both P <0.01). Conclusions Nearly one third of patients initiated triple therapy with SVR rates comparable to other HCV treatment settings, despite a significant burden of mental illness and substance dependence. Our experience demonstrates that a primary care-based practice can successfully deliver HCV care to a vulnerable population. Additional interventions may be needed to improve outcomes in patients with recent or past substance use disorders or psychiatric illness.

Objectives Pegylated-interferon/ribavirin dual therapy for hepatitis C virus (HCV) has a lower sustained virologic response (SVR) rate in HIV/HCV-co-infected patients than in HCV mono-infected patients, but little is known about the relative effectiveness of teleprevir-based triple therapy in the two groups. Methods Data on 33 co-infected and 116 mono-infected patients were analyzed on an intention-to-treat basis. SVR12 was defined as undetectable HCV RNA at week-12 post-end-of-treatment, severe anemia as hemoglobin ≤89 g/L or a drop ≥45 g/L, and advanced fibrosis/cirrhosis as Fib-4 ≥3.25. All co-infected patients had well-controlled HIV. Results The groups were similar in age, gender, percentage with Fib-4 ≥3.25, and HCV viral load, but differed in previous treatment response, with more co-infected patients non responders/treatment intolerant (75.8% vs. 50.0%, <0.01). During treatment, the percentages of patients with undetectable HCV RNA were similar, but, surprisingly, tended to be higher in co-infected patients. SVR12 rates were 60.6% (co-infected) vs. 42.2% (mono-infected), p=0.06. In multivariable analysis, SVR12 was associated with HIV infection (OR: 3.55, p<0.01), African American race (OR: 0.37, p=0.03) and previous treatment response (OR: 0.46, p=0.03). Rates of severe anemia (45.5% vs. 58.6%, p=0.18) were similar in the two groups, but rash (15.2% vs. 34.5%, p=0.03) and rectal symptoms (12.1% vs. 43.1%, p<0.01) were less common in co-infected patients. Conclusions Virologic responses of co- and mono-infected patients did not differ significantly, but tended to be higher in co-infected patients, who had a 60.6% SVR12 rate. Telaprevir-based triple therapy is a promising option for co-infected patients with well-controlled HIV.

SUMMARY Background Data about adverse events are needed to optimise telaprevir-based therapy in a broad spectrum of patients. Aim To investigate adverse events of telaprevir-based therapy in patients with and without advanced fibrosis or cirrhosis in a real-world setting. Methods Data on 174 hepatitis C-infected patients initiating telaprevir-based therapy at Mount Sinai and Montefiore medical centres were collected. Biopsy data and FIB-4 scores identified patients with advanced fibrosis. Multivariable fully adjusted models were built to assess the effect of advanced fibrosis on specific adverse events and discontinuation of treatment due to an adverse event. Results Patients with (n = 71) and without (n = 103) advanced fibrosis were similar in BMI, ribavirin exposure, gender, prior treatment history, haemoglobin and creatinine, but differed in race. Overall, 47% of patients completed treatment and 40% of patients achieved SVR. Treated patients with and without advanced fibrosis or cirrhosis had similar rates of adverse events; advanced fibrosis, however, was independently associated with ano-rectal discomfort (P = 0.03). Three patients decompensated and had advanced fibrosis. The discontinuation of all treatment medications due to an adverse event was significantly associated with older age (P = 0.01), female gender (P = 0.01) and lower platelets (P = 0.03). Conclusions Adverse events were common, but were not significantly related to the presence of advanced fibrosis or cirrhosis. More critical monitoring in older and female patients with low platelets throughout treatment may reduce adverse event-related discontinuations.