Death Rate Higher In C.diff Patients Who Do Not Receive Guideline-Adherent Therapy

MedicalResearch.com Interview with:

Dr. Shannon Novosad, MD Epidemic Intelligence Service, CDC Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases

Dr. Shannon Novosad

Dr. Shannon Novosad, MD
Epidemic Intelligence Service, CDC
Division of Healthcare Quality Promotion
National Center for Emerging and Zoonotic Infectious Diseases

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Clostridium difficile can cause an infection in the colon called colitis. Symptoms include diarrhea, fever, nausea, and abdominal pain. It is an important cause of healthcare associated infections with approximately half a million C. difficile infections and 29,000 associated deaths in 2011. The Infectious Diseases Society of America and Society for Healthcare Epidemiology of America published guidelines in 2010 advising clinicians on appropriate antibiotic regimens to treat C. difficile infection.  Prior studies have found that provider adherence to these guidelines, particularly in those with severe disease, is poor.  However, these studies primarily involved patients treated at a single healthcare facility. We were interested in examining CDI treatment practices in a larger group of patients with C. difficile infection located across geographically diverse areas. Further we wanted to learn more about what patient characteristics might be associated with receiving guideline-adherent therapy for C. difficile infection.

We used data from the Center for Disease Control and Prevention’s Emerging Infections Program (EIP) which performs active population and laboratory-based surveillance for C. difficile infections in 10 U.S. sites and examined how 11,717 patients including 2006 with severe disease were treated. We found that provider adherence to national treatment guidelines was low with only around 40% of those with severe disease being prescribed the appropriate antibiotic treatment. Our analysis suggests that those who were tested for C. difficile in the hospital or who were admitted to the hospital around the time of diagnosis were more likely to receive recommended antibiotic therapy.

In addition, patients greater than 65 years old or with more underlying comorbidities were more likely to receive the right antibiotic treatment. We also found that after adjusting for age and underlying comorbidities, the odds of death within 30 days of diagnosis was almost 400% higher in patients who did not receive guideline-adherent therapy compared to those who did.

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Ibalizumab Decreased Viral Load In Patients With Resistant HIV

MedicalResearch.com Interview with:

Jacob Lalezari, MD Quest Clinical Research San Francisco, CA

Dr. Jacob Lalezari

Jacob Lalezari, MD
Quest Clinical Research
San Francisco, CA 

MedicalResearch.com: What is the background for this study? What are the main findings?

  • Tremendous strides have been made since HIV-1 was first discovered 35 years ago. However, while many HIV patients can control the infection with currently-approved therapies, there is an urgent need for new treatments that can address viruses that are resistant to multiple antiretroviral treatment classes. With people starting treatments earlier and staying on them longer, some patients also face long-term safety and tolerability issues associated with current therapies.
  • Thousands of people are infected with HIV-1 with resistance to three classes of antiretroviral therapy (ART), and are in dire need of treatment. There are limited or no treatment options available for these patients.
  • As multi-drug resistant (MDR) HIV can be transmitted, it is imperative that it be controlled in order to prevent it from becoming a larger problem. It is important to not only focus on the patient being treated but also consider those they could infect.
  • Ibalizumab is the first biologic long-acting investigational ART to show efficacy in patients in just seven days. The Phase III TMB-301 results showed that patients with MDR HIV-1 and with limited treatment options experienced a significant decrease in viral load after receiving a loading dose of ibalizumab (2,000 mg intravenously) in addition to their failing ART therapies.
    •  A total of 40 patients were enrolled in the study.
    • Seven days after the loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period.
    • These results were statistically significant (p<0.0001). Moreover, during that same period, 60% achieved a decrease of ≥1.0 log10.
    • The average viral load decrease for the total population was 1.1 log10
    • There were no treatment-related serious adverse events or discontinuations reported during the initial seven-day treatment period. 

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EHRs Can Help Identify Patients Who May Benefit From HIV PrEP Medications

MedicalResearch.com Interview with:

Douglas Krakower, MD Infectious Disease Division Beth Israel Deaconess Medical Center Boston, MA,

Dr. Douglas Krakower

Douglas Krakower, MD
Infectious Disease Division
Beth Israel Deaconess Medical Center
Boston, MA,

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are 45,000 new HIV infections in the US annually, so effective HIV prevention strategies are needed. HIV pre-exposure prophylaxis (PrEP), whereby a person who is HIV-uninfected uses an HIV treatment medication on a daily basis to protect themselves from becoming infected with HIV, is over 90% effective when taken with high adherence. The Centers for Disease Control and Prevention estimates that there are 1.2 million Americans who are likely to benefit from using PrEP. However, only 80,000 persons have been prescribed PrEP. One of the barriers to implementing PrEP is that clinicians face challenges with identifying persons who are most likely to benefit from PrEP, given infrequent sexual health history assessments during routine clinical care. We thus sought to develop an automated algorithm that uses structured data from electronic health records (EHRs) to identify patients who are most likely to benefit from using PrEP. Our methods included extracting potentially relevant EHR data for patients with incident HIV and without HIV from nearly a decade of EHR data from a large ambulatory practice in Massachusetts. We then used machine learning algorithms to predict HIV infection in those with incident HIV and those without HIV. We found that some algorithms could offer clinically useful predictive power to identify persons who were more likely to become infected with HIV as compared to controls. When we applied these algorithms to the general population and identified a subset of about 1% of the population with risk scores above an inflection point in the total distribution of risk scores; these persons may be appropriate for HIV testing and/or discussions about PrEP.

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