The impact of viral load suppression, genotype, race, and other factors on the risk of late-stage liver-related events in patients with hepatitis C (HCV) has been assessed previously using data from small observational cohorts or clinical trials. Data from large real-world practice samples are needed to improve risk factor estimates for late-stage liver events and death in HCV.OBJECTIVE To describe the natural history of HCV in real-world clinical practice. DESIGN, SETTING, AND PARTICIPANTS Observational cohort study. Patients with a detectable viral load (>25 IU/mL) and a recorded baseline genotype were selected from the Veterans Affairs (VA) HCV clinical registry (CCR), which compiles electronic medical records data from 1999 to present.EXPOSURES Risk factors included genotype, race, age, sex, and time to achieving an observed undetected viral load. MAIN OUTCOMES AND MEASURESThe primary outcomes were time to death and time to a composite of liver-related clinical events. Secondary outcomes included the components of the composite clinical outcome. Outcomes were measured using a time-to-event format and were analyzed using Cox proportional hazards models.RESULTS A total of 28 769 of 360 857 unique HCV CCR patients met all study criteria. Only 24.3% of patients received treatment, and 16.4% of treated patients (4.0% of all patients) achieved an undetectable viral load. The unadjusted death rates were 6.8 (95% CI, 6.0-7.7) per 1000 person-years for patients who achieved viral load suppression vs 21.8 (95% CI, 21.5-22.2) deaths per 1000 person-years in patients who did not achieve this goal. Cox model results found that achieving viral suppression reduced risk of the composite clinical end point by 27% (hazard ratio [HR], 0.73 [95% CI, 0.66-0.82]) and the risk of death by 45% (HR, 0.55 [95% CI, 0.47-0.64]). Genotype 2 patients were at significantly lower risk, and genotype 3 patients were at higher risk for all study outcomes relative to genotype 1. Black patients were at lower risk for all liver events than white patients. CONCLUSION AND RELEVANCEAchieving an undetectable viral load was associated with decreased hepatic morbidity and mortality. It remains to be determined whether newer treatment regimens can offer higher response rates with fewer adverse effects in real-world settings.

This study shows the negative impact of higher pill burden on medication adherence, an important factor associated with treatment outcomes in patients with HIV/AIDS.

BackgroundHepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels predict future complications in chronic hepatitis B (CHB) patients. To determine when to initiate antiviral therapy, treatment guidelines recommend monitoring of HBV DNA and ALT levels at least annually. This study aimed to assess adherence to treatment guideline-recommended monitoring of CHB patients not receiving antiviral treatment and to identify predictors of laboratory monitoring and subsequent initiation of antiviral therapy.MethodsThis retrospective cohort study used data from a large US health care claims database over a 5-year period (January 1, 2003 to December 31, 2007). The study population included patients 18–65 years of age with at least two paid medical claims with an ICD-9 code for CHB, at least one positive hepatitis B surface antigen test, and at least 12 months of continuous health plan enrollment after initial diagnosis. Descriptive statistics assessed the proportion of patients with claims for ALT and/or HBV DNA monitoring. Multivariate logistic regression models were used to determine predictors of monitoring and subsequent antiviral therapy.ResultsThe study included 1,168 CHB patients, with a mean follow-up of 728 days (median = 696 days). The proportion monitored at least every 12 months was 53.3% for ALT, 39.0% for HBV DNA, and 35.1% for both. Significant predictors of monitoring were a higher Deyo-Charlson Comorbidity Index (DCCI) score for ALT (OR 1.90, p < 0.001), male gender for HBV DNA (OR 1.49, p < 0.01), and a higher DCCI score (OR 1.10, p < 0.05) and male gender (1.46, p < 0.01) for both. Significant predictors of subsequent initiation of antiviral treatment were HBV DNA monitoring (OR 2.08, p < 0.001), a higher DCCI score (OR 1.24, p < 0.001), and male gender (OR 1.53, p < 0.01).ConclusionsLaboratory monitoring of CHB patients not receiving antiviral treatment is below guideline recommendations, suggesting that initiation of antiviral therapy may also be delayed, leaving patients at risk for disease progression.

This study examined factors associated with persistence (time from initiation to discontinuation of treatment) on initial antiretroviral (ARV) therapy in commercially insured HIV patients in the United States, a population not well researched. This retrospective analysis of US health insurance claims data from 1 January 2003 to 30 June 2008 included treatment-naive patients aged 18–65 years with an HIV diagnosis receiving ARV therapy consisting of at least two individual nucleoside reverse transcriptase inhibitors (NRTIs) or one fixed-dose combination NRTI, plus at least one nonnucleoside reverse transcriptase inhibitor (NNRTI) or one protease inhibitor (PI), with or without ritonavir. Descriptive statistics, Kaplan-Meier survival estimation, and Cox proportional hazards regression models were completed. Patients were considered persistent until any component of the regimen was modified or there was a gap in treatment > 90 days. A total of 2460 patients met full inclusion criteria (1388 NNRTI and 1072 PI). Mean (SD) time to discontinuation for NNRTI- vs PI-based regimens was 370 (346) vs 295 (338) days (p < 0.001). Female sex, substance use, low comorbidity score, index year before 2007, geographical region, and taking a lopinavir/ritonavir regimen predicted discontinuation. Relative to NNRTI-based regimens, PI-based regimens demonstrated a greater risk of discontinuation (hazard ratio [HR], 1.32; p <0.001). The fixed-dose efavirenz/emtricitabine/tenofovir combination yielded the lowest risk of discontinuation (HR, 0.39; p < 0.001). HIV treatment persistence was longer with NNRTI-based regimens than PI-based regimens. The fixed-dose regimen of once-daily efavirenz/emtricitabine/tenofovir had the lowest risk of discontinuation.

BackgroundCT-P13, a biosimilar drug product to infliximab, was approved and marketed in July 2014 in Turkey. There is little information on the costs, treatment discontinuation and adverse events and reactions between patients who switched from infliximab to CT-P13 and patients who continued infliximab.ObjectivesThe study objective was to evaluate health care costs, treatment discontinuation, and adverse events and reactions between patients who switched from infliximab to CT-P13 and patients who continued infliximab in the Turkish population.MethodsAdult patients with ≥1 claim for infliximab or CT-P13 were identified in a Turkish healthcare administrative database representing 80% of the Turkish population during the identification period (16 July 2014–31 Aug 2015). Patients were required to continuously use infliximab for ≥6 months with no hospitalizations. Eligible patients either continued on infliximab (index date: date of first infliximab prescription), or switched from infliximab to CT-P13 (index date: switch date). Patients were excluded if they had ≥1 condition with an indication for infliximab during the baseline period. Patients who switched to CT-P13 were 1:10 matched to patients who continued infliximab based on the length of infliximab use prior to the index date. Demographics and clinical characteristics were measured 12 months pre-index date. Generalized linear models were used to compare adjusted health care costs, Cox regression was used to evaluate the adjusted risk of discontinuation, and Poisson regression was used to evaluate the adjusted risk of adverse events and reactions.ResultsThe study included 1,524 patients, of whom 1,388 were continuous infliximab users and 136 switched to CT-P13. Ankylosing spondylitis and rheumatoid arthritis were the most common conditions indicated for infliximab and CT-P13; however, patients were much less likely to be switched to CT-P13 for other conditions. After adjusting for demographics and clinical characteristics, patients who switched to CT-P13 had higher outpatient ([Turkish lira] TL 269 vs TL 181; p=0.005), inpatient (TL 64 vs TL 29; p=0.313), and pharmacy costs (TL 1,473 vs TL 1,329; p=0.371), which resulted in significantly higher total health care costs (TL 2,009 vs TL 1,640; p=0.046) compared to patients who continued infliximab. Additionally, patients who switched to CT-P13 were more likely to discontinue treatment (13.2 vs 1.52 per 1000 person-years) compared to those who continued infliximab. Of patients who discontinued CT-P13, 79% switched back to infliximab. After adjusting for baseline characteristics, patients who switched to CT-P13 were significantly more likely to discontinue treatment compared to those who continued infliximab (HR=5.53; 95% CI: 4.01–7.63). There was no difference in the adjusted incidence rate ratio (IRR) between the cohorts for adverse events (IRR=0.67; 95% CI: 0.19–2.30) and reactions (IRR=0.84; 95% CI: 0.55–1.27).ConclusionsPatients who switched to CT-P13 had significantly higher health care costs and were also more l...

In late 2009 US guidelines for HIV treatment were revised to recommend the initiation of combination antiretroviral therapy (cART) earlier in the course of the disease. We analyzed the life expectancy gains of people infected with HIV between the introduction of cART in 1996 and the 2009 guideline revisions. Compared to people who initiated cART late (defined as having a CD4 cell count of less than 350 per cubic millimeter of blood), those who initiated treatment early (with a CD4 count of 350-500) could expect to live 6.1 years longer, and the earliest initiators (with a CD4 count of more than 500) could expect an extra 9.0 years of life. The total value of life expectancy gains to the early and earliest initiators of treatment was $80 billion, with each life-year valued at $150,000. The value of the survival gains was more than double the increase in drug manufacturers' revenues from early cART initiation. Our results clarify the economic implications of adherence to treatment guidelines.

Objective: To estimate the public health impact of comprehensive hepatitis C virus (HCV) screening and access to all-oral, interferon (IFN)-free direct-acting antivirals (DAAs) in the French baby-boomer population ARTICLE HISTORY

By more effectively reducing viral load with less gastrointestinal toxicity and a better lipid profile, ATV + r lowered rates of AIDS and CHD, increased quality-adjusted survival, and was cost effective (< $50,000/QALY) compared with LPV/r.