Valérie Martel-Laferrière

Sensitivities of Antigen Detection and PCR Assays Greatly Increased Compared to That of the Standard Culture Method for Screening for Group B Streptococcus Carriage in Pregnant Women

ABSTRACT Group B streptococcus (GBS) is a major cause of serious infections in neonates. The 2002 revised guidelines of the Centers for Disease Control and Prevention (CDC) for the prevention of perinatal GBS disease recommend that all pregnant women be screened for GBS carriage at between 35 and 37 weeks of gestation and that intrapartum antibiotic prophylaxis be given to carriers. We studied the performances of four different GBS detection assays in the context of antenatal screening. Between May and August 2004, the 605 vaginorectal swab specimens received at our bacteriology laboratory for GBS antenatal detection were tested by the four assays. The standard culture method was done according to the CDC recommendations. The three experimental assays performed with the growth from the selective enrichment (LIM) broth (Todd-Hewitt broth with 15 μg/ml nalidixic acid and 10 μg/ml colistin) after overnight incubation were a GBS antigen detection assay (PathoDx) and two PCR assays (for cfb and scpB). The most accurate assay was the scpB PCR (sensitivity, 99.6%; specificity, 100%), followed by the cfb PCR (sensitivity, 75.3%; specificity, 100%), GBS antigen detection (sensitivity, 57.3%; specificity, 99.5%), and standard culture (sensitivity, 42.3%; specificity, 100%). The GBS antigen detection assay was found to be more sensitive than the standard culture method, and moreover, the assay has a low cost and is easy to perform in all obstetrical centers which have access to the most basic of diagnostic microbiology services. We believe that antigen detection on incubated LIM broth should replace the standard culture method for screening for GBS carriage at 35 to 37 weeks of gestation. The impact of the greater sensitivities of PCR assays on the diminution of neonatal GBS infections remains to be demonstrated.

How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World?

Trial results are used to support licensure, inform cost-effectiveness analyses, and guide clinical decision making. We found the majority of coinfected patients were not included in clinical trials of direct-acting antivirals, raising concerns about the generalizability of these trial results.

How generalizable are the results from trials of Direct Antiviral Agents to people coinfected with HIV/Hepatitis C virus in the real world?

Trial results are used to support licensure, inform cost-effectiveness analyses, and guide clinical decision making. We found the majority of coinfected patients were not included in clinical trials of direct-acting antivirals, raising concerns about the generalizability of these trial results.

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

Virological response rates for telaprevir-based hepatitis C triple therapy in patients with and without HIV coinfection

83,721 per patient (IQR = 

High incidence of herpes zoster in nonmyeloablative hematopoietic stem cell transplantation.

66,652‐

Early Initiation Rather Than Prolonged Duration of Antiretroviral Therapy in HIV Infection Contributes to the Normalization of CD8 T-Cell Counts

98,102). The median cost per SVR was

Effect of fibrosis on adverse events in patients with hepatitis C treated with telaprevir

189,338 (IQR = 

Hepatitis C direct-acting antiviral agents: changing the paradigm of hepatitis C treatment in HIV-infected patients.

150,735‐