SUMMARY Background Treatment of hepatitis C virus (HCV) infection with pegylated interferon/ribavirin achieves sustained virological response in up to 56% of HCV mono-infected patients and 40% of HCV/human immunodeficiency virus (HIV)-co-infected patients. The relationship of patient adherence to outcome warrants study. Aim To review comprehensively research on patient-missed doses to HCV treatment and discuss applicable research from adherence to HIV antiretroviral therapy. Methods Publications were identified by PubMed searches using the keywords: adherence, compliance, hepatitis C virus, interferon and ribavirin. Results The term ‘non-adherence’ differs in how it is used in the HCV from the HIV literature. In HCV, ‘non-adherence’ refers primarily to dose reductions by the clinician and early treatment discontinuation. In contrast, in HIV, ‘non-adherence’ refers primarily to patient-missed doses. Few data have been published on the rates of missed dose adherence to pegylated interferon/ribavirin and its relationship to virological response. Conclusions As HCV treatment becomes more complex with new classes of agents, adherence will be increasingly important to treatment success as resistance mutations may develop with suboptimal dosing of HCV enzyme inhibitors. HIV adherence research can be applied to that on HCV to establish accurate methods to assess adherence, investigate determinants of non-adherence and develop strategies to optimize adherence.

Incorporating telaprevir into treatment of acute genotype 1 HCV in HIV-infected men halved the treatment duration and increased the SVR rate. Larger studies should be done to confirm these findings. Clinicians should be alert to detect acute HCV infection of HIV-infected men to take advantage of this effective therapy and decrease further transmission in this epidemic.

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.

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.

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