0
Basic View | Expanded View
Showing 1-17 of 17 Articles
Original Research | 
Mark S. Sulkowski, MD; Kenneth E. Sherman, MD, PhD; Douglas T. Dieterich, MD; Mohammad Bsharat, PhD; Lisa Mahnke, MD, PhD; Jürgen K. Rockstroh, MD; Shahin Gharakhanian, MD, DPH; Scott McCallister, MD; Joshua Henshaw, PhD; Pierre-Marie Girard, MD, PhD; Bambang Adiwijaya, PhD; Varun Garg, PhD; Raymond A. Rubin, MD; Nathalie Adda, MD; and Vincent Soriano, MD, PhD
Background:Telaprevir (TVR) plus peginterferon-α2a (PEG-IFN-α2a) and ribavirin substantially increases treatment efficacy for genotype 1 chronic hepatitis C virus (HCV) infection versus PEG-IFN-α2a–ribavirin alone. Its safety and efficacy in patients with HCV and HIV-1 are unknown. Objective:To assess the safety and efficacy of TVR plus PEG-IFN-α2a–ribavirin in patients with genotype 1 HCV and HIV-1 and evaluate pharmacokinetics of TVR and antiretrovirals during coadministration. Design:Phase 2a, randomized, double-blind, placebo-controlled study. (ClinicalTrials.gov: NCT00983853) Setting:16 international multicenter sites. Patients:62 patients with HCV genotype 1 and HIV-1 who were HCV treatment–naive and taking 0 or 1 of 2 antiretroviral regimens were randomly assigned to TVR plus PEG-IFN-α2a–ribavirin or placebo plus PEG-IFN-α2a–ribavirin for 12 weeks, plus 36 weeks of PEG-IFN-α2a–ribavirin. Measurements:HCV RNA concentrations. Results:Pruritus, headache, nausea, rash, and dizziness were higher with TVR plus PEG-IFN-α2a–ribavirin during the first 12 weeks. Serious adverse events occurred in 5% (2 in 38) of those receiving TVR plus PEG-IFN-α2a–ribavirin and 0% (0 in 22) of those receiving placebo plus PEG-IFN-α2a–ribavirin; the same number in both groups discontinued treatment due to adverse events. Sustained virologic response occurred in 74% (28 in 38) of patients receiving TVR plus PEG-IFN-α2a–ribavirin and 45% (10 in 22) of patients receiving placebo plus PEG-IFN-α2a–ribavirin. Rapid HCV suppression was seen with TVR plus PEG-IFN-α2a–ribavirin (68% [26 in 38 patients] vs. 0% [0 in 22 patients] undetectable HCV RNA levels by week 4). Two patients had on-treatment HCV breakthrough with TVR-resistant variants. Patients treated with antiretroviral drugs had no HIV breakthroughs; antiretroviral exposure was not substantially modified by TVR. Limitation:Small sample size and appreciable dropout rate. Conclusion:In patients with HCV and HIV-1, more adverse events occurred with TVR versus placebo plus PEG-IFN-α2a–ribavirin; these were similar in nature and severity to those in patients with HCV treated with TVR. With or without concomitant antiretrovirals, sustained virologic response rates were higher in patients treated with TVR versus placebo plus PEG-IFN-α2a–ribavirin. Primary Funding Source:Vertex Pharmaceuticals and Janssen Pharmaceuticals.
Topics: hiv, hepatitis c, chronic, hepatitis c rna, combined modality therapy, genotype, ribavirin, infection, viruses, hepatitis c virus, anti-retroviral agents, telaprevir
Ideas and Opinions | 
Allen Frances, MD
The American Psychiatric Association has released the long-awaited fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). This commentary notes that the DSM-5 “introduced several high-prevalence diagnoses at the fuzzy boundary with normality” and recommends that “physicians … use the DSM-5 cautiously, if at all.”
Topics: diagnosis, psychiatric
Topics: alcohol abuse, advisory committees, behavior therapy, prevention
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Description:Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening and behavioral counseling interventions in primary care to reduce alcohol misuse. Methods:The USPSTF reviewed new evidence on the effectiveness of screening for alcohol misuse for improving health outcomes, the accuracy of various screening approaches, the effectiveness of various behavioral counseling interventions for improving intermediate or long-term health outcomes, the harms of screening and behavioral counseling interventions, and influences from the health care system that promote or detract from effective screening and counseling interventions for alcohol misuse. Population:These recommendations apply to adolescents aged 12 to 17 years and adults aged 18 years or older. These recommendations do not apply to persons who are actively seeking evaluation or treatment for alcohol misuse. Recommendation:The USPSTF recommends that clinicians screen adults aged 18 years or older for alcohol misuse and provide persons engaged in risky or hazardous drinking with brief behavioral counseling interventions to reduce alcohol misuse. (Grade B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening and behavioral counseling interventions in primary care settings to reduce alcohol misuse in adolescents. (I statement)
Topics: alcohol abuse, advisory committees, behavior therapy, primary health care, united states preventive services task force, prevention
Ideas and Opinions | 
Andrew T. Pavia, MD
On 31 March 2013, Chinese public health authorities notified the World Health Organization of the isolation of influenza A(H7N9) virus from 3 critically ill adults. This avian influenza virus had never before been detected in humans, and its association with severe disease shocked experts. This commentary asks whether we should be concerned and whether we are fully prepared for a pandemic.
Topics: anxiety, influenza, influenzavirus a, influenza a virus, h7n9 subtype
Editorials | 
Moupali Das, MD, MPH; and Paul Volberding, MD
The updated U.S. Preventive Services Task Force recommendations converge with those from the Centers for Disease Control and Prevention. The editorialists comment on the Task Force recommendations and see them as informing the roadmap to the elusive end to AIDS.
Topics: vision, hiv screen, consensus
Clinical Guidelines | 
Virginia A. Moyer, MD, MPH, on behalf of the U.S. Preventive Services Task Force*
Includes: Supplemental Content
Description:Update of the 2005 U.S. Preventive Services Task Force (USPSTF) recommendation statement on screening for HIV. Methods:The USPSTF reviewed new evidence on the effectiveness of treatments in HIV-infected persons with CD4 counts greater than 0.200 × 109 cells/L; effects of screening, counseling, and antiretroviral therapy (ART) use on risky behaviors and HIV transmission risk; and long-term cardiovascular harms of ART. Population:These recommendations apply to adolescents, adults, and pregnant women. Recommendation:The USPSTF recommends that clinicians screen adolescents and adults aged 15 to 65 years for HIV infection. Younger adolescents and older adults who are at increased risk should also be screened. (Grade A recommendation) The USPSTF recommends that clinicians screen all pregnant women for HIV, including those who present in labor who are untested and whose HIV status is unknown. (Grade A recommendation)
Topics: hiv, advisory committees, cd4 count determination procedure, hiv seropositivity, hiv infection, hiv screen, united states preventive services task force, prevention
Topics: advisory committees, hiv screen, prevention
Ideas and Opinions | 
Alasdair Conn, MD
We thought it would be a normal Marathon Monday at Massachusetts General Hospital. The Boston Marathon is always held on the third Monday in April and is a public holiday—Patriots Day. The hospital normally expects to receive about 15 to 20 marathon runners with hyponatremia and dehydration, many more are treated at the medical tents along the route of the marathon. For many this is a day that Bostonians look forward to as the unofficial start of spring.
Topics: dehydration, disasters, explosions, hospitals, operating room, disasters and emergency preparedness
Ideas and Opinions | 
Deborah Cotton, MD, MPH, Deputy Editor
The Boston health care war had really stepped up at the end of winter. The hospitals were competing furiously for us to be their patients. Their ads boasted: “Individual Care/Global Impact,” “Human First,” “Exceptional Care Without Exception.” They told us we should choose them because they were big, because they were small, because they alone could transplant faces, because they knew our neighborhoods, because they performed true miracles every day. And then it was a Perfect Spring Day and the Marathon was in full swing. Many of the runners were nurses. Many of the runners were doctors. Many were EMTs and health policy experts and insurance executives and legislators and some were even hospital CEOs. When the finish line exploded, the nurses and doctors and EMTs all ran to help and we could not tell them apart if we tried.
Topics: care of intensive care unit patient, health policy, hospitals, insurance carriers, nurses, money
Updates | 
Janet A. Schlechte, MD
This Update summarizes studies published in 2012 that the authors consider highly relevant to the practice of endocrinology. Topics include diabetes mellitus, thyroid disease, and osteoporosis and fractures.
Topics: obesity, osteoporosis, metformin, diabetes mellitus, type 2, cancer, fracture, endocrinology, spinal fractures, vitamin d, women, radioactive iodine, zoledronic acid, insulin, glargine, human, glucose control, bariatric surgery, ablation
Updates | 
Atul Deodhar, MD
This Update summarizes studies published in 2012 that the authors consider highly relevant to the practice of rheumatology. Topics include treatment of rheumatologic disease, pharmacoepidemiology, diagnostic testing, and new practice guidelines.
Topics: arthritis, gout, anti-inflammatory agents, non-steroidal, rheumatology, infection, guidelines, rituximab
Updates | 
Megan McNamara*, MD, MSc; and Judith M.E. Walsh*, MD, MPH
This Update summarizes studies published in 2012 that the authors consider highly relevant to the practice of women's health. Topics include reproductive health, menopause, prevention and screening, and osteoporosis and bone health.
Topics: osteoporosis, hormone replacement therapy, calcium, contraceptive methods, hip fractures, women's health, women, proton pump inhibitors, endocrine therapy, venous thromboembolism
Updates | 
A. Scott Keller, MD, MS; Tamara E. Buechler, MD, MHA; and James S. Newman, MD
This Update summarizes studies published in 2012 that the authors consider highly relevant to the practice of hospital medicine. Topics include perioperative myocardial infarction, anticoagulation, inpatient care, and transfusion medicine.
Topics: warfarin, hemorrhage, hospitals, patient readmission, mortality, hospital care
In the Balance | 
Hillary V. Kunins, MD, MPH, MS; Thomas A. Farley, MD, MPH; and Deborah Dowell, MD, MPH
Adverse consequences of opioid analgesic use have increased dramatically in the United States. In January 2013, the New York City Department of Health and Mental Hygiene released guidelines to help reduce the misuse of prescription opioid analgesics by establishing standards for prescribing from the emergency department. In this commentary, authors employed by the department that issued the guidelines discuss the recommendations and why they are likely to help emergency and other physicians provide safer care for patients with pain.
Topics: opioid analgesics, guidelines
In the Balance | 
Alex M. Rosenau, DO
Adverse consequences of opioid analgesic use have increased dramatically in the United States. In January 2013, the New York City Department of Health and Mental Hygiene released guidelines to help reduce the misuse of prescription opioid analgesics by establishing standards for prescribing from the emergency department. In this commentary, the President-elect of the American College of Emergency Physicians argues that restricting opioid prescription by emergency physicians will not solve the problem of opioid misuse. Rather, closing corrupt pain centers and improving access to high quality non-emergency care will improve the care of patients with pain.
Topics: opioid analgesics, guidelines
Ideas and Opinions | 
Daniel Grossman, MD
In December 2012, the American College of Obstetricians and Gynecologists released a Committee Opinion supporting over-the-counter access to oral contraceptive pills. This commentary discusses evidence that over-the-counter provision of oral contraceptive pills is a safe and effective strategy for reducing unintended pregnancies.
Topics: oral contraceptives, drugs, non-prescription, unplanned pregnancy
Advertisement

Buy This Article

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)