Donald Gardenier

Telaprevir in the Treatment of Acute Hepatitis C Virus Infection in HIV-Infected Men

BACKGROUND There is an international epidemic of hepatitis C virus (HCV) infection among human immunodeficiency virus (HIV)-infected men who have sex with men. Sustained virologic response (SVR) rates with pegylated interferon and ribavirin treatment are higher in these men during acute HCV than during chronic HCV, but treatment is still lengthy and SVR rates are suboptimal. METHODS We performed a pilot study of combination therapy with telaprevir, pegylated interferon, and ribavirin in acute genotype 1 HCV infection in HIV-infected men. Men who were treated prior to the availability of, or ineligible for, telaprevir were the comparator group. The primary endpoint was SVR12, defined as an HCV viral load <5 IU/mL at least 12 weeks after completing treatment. RESULTS In the telaprevir group, 84% (16/19) of men achieved SVR12 vs 63% (30/48) in the comparator group. Among men with SVR, median time to undetectable viral load was week 2 in the telaprevir group vs week 4 in the comparator group, and 94% vs 53% had undetectable viral loads at week 4. Most patients (81%) who achieved SVR in the telaprevir group received ≤12 weeks of treatment and there were no relapses after treatment. The overall safety profile was similar to that known for telaprevir-based regimens. CONCLUSIONS 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.

Costs of telaprevir-based triple therapy for hepatitis C:

In registration trials, triple therapy with telaprevir (TVR), pegylated interferon (Peg‐IFN), and ribavirin (RBV) achieved sustained virological response (SVR) rates between 64% and 75%, but the clinical effectiveness and economic burdens of this treatment in real‐world practice remain to be determined. Records of 147 patients who initiated TVR‐based triple therapy at the Mount Sinai Medical Center (May‐December 2011) were reviewed. Direct medical costs for pretreatment, on‐treatment, and posttreatment care were calculated using data from Medicare reimbursement databases, RED Book, and the Healthcare Cost and Utilization Project database. Costs are presented in 2012 U.S. dollars. SVR (undetectable hepatitis C virus [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. Median age of the 147 patients was 56 years (interquartile range [IQR] = 51‐61), 68% were male, 19% were black, 11% had human immunodeficiency virus/HCV coinfection, 36% had advanced fibrosis/cirrhosis (FIB‐4 scores ≥3.25), and 44% achieved an SVR. The total cost of care was

189,000 per sustained virological response.

11.56 million. Median cost of care was

Validation of a Hepatitis C Screening Tool in Primary Care

83,721 per patient (IQR = 

Real-World Sustained Virologic Response Rates of Sofosbuvir-Containing Regimens in Patients Coinfected With Hepatitis C and HIV

66,652‐

Hepatitis C treatment completion in individuals with psychiatric comorbidity and depression.

98,102). The median cost per SVR was

Primary Care-Based Hepatitis C Treatment Outcomes With First-Generation Direct-Acting Agents

189,338 (IQR = 

Hepatitis C in an Urban Cohort: Who's Not Being Treated?

150,735‐

Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus

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 Peg‐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. (Hepatology 2014;60:1187–1195)

Illness Perceptions, Medication Beliefs, and Adherence to Antiretrovirals and Medications for Comorbidities in Adults With HIV Infection and Hypertension or Chronic Kidney Disease.

BACKGROUND Although hepatitis C virus (HCV) has an estimated national prevalence of 1.8%, testing rates are lower than those recommended by guidelines, particularly in primary care. A critical step is the ability to identify patients at increased risk who should be screened. We sought to prospectively derive and validate a clinical predication tool to assist primary care providers in identifying patients who should be tested for HCV antibodies. METHODS A total of 1000 randomly selected patients attending an inner-city primary care clinic filled out a 27-item questionnaire assessing 5 HCV risk factor domains: work, medical, exposure, personal care, and social history. Afterward, the patients underwent HCV antibody testing. Multivariable logistic regression analysis was performed to identify risk factors associated with HCV antibodies. RESULTS There was an 8.3% (95% confidence interval, 6.7%-10.2%) prevalence of HCV antibodies. The patients who were HCV antibody positive were more likely to be male, older, and insured by Medicaid (P < or = .02). Those who had risk factors within the medical, exposure, and social history domains were more likely to be HCV antibody positive. The area under the receiver operating characteristic curve for the screening tool based on these 3 domains was 0.77. With an increasing number of positive domains, there was a higher likelihood of HCV antibody positivity. Only 2% of patients with 0 risk factors had HCV antibodies. CONCLUSIONS A prediction tool can be used to accurately identify patients at high risk of HCV who may benefit from serologic screening. Future studies should assess whether wider use of this tool may lead to improved outcomes.