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Issue No. 19 | May 6, 2011

News and Features

FDA Updates Enfuvirtide (Fuzeon) Label with New Data on Incidence of Bacterial Pneumonia

“Updates to the Warnings and Precautions, Pneumonia subsection of the Fuzeon (enfuvirtide) package insert were approved on April 28, 2011 in response to results of a study conducted under a Postmarketing Commitment.  Drug sponsor, Roche, submitted the results from an ‘Observational Cohort Study on the Incidence of Pneumonia in HIV-1 Patients Treated with Fuzeon.’ …

“The findings from the study are included in Warnings and Precautions section 5.3 Pneumonia of the package insert as follows. …

Because it was unclear whether the higher incidence rate of pneumonia was related to FUZEON use, an observational study in 1850 HIV-infected patients (740 FUZEON treated patients and 1110 non-FUZEON treated patients) was conducted to evaluate the risk of pneumonia in patients treated with FUZEON. A total of 123 patients had a confirmed or probable pneumonia event in this study (62 in the FUZEON treatment arm with 1962 patient-years of observation and 61 in the non-FUZEON treatment arm with 3378 patient-years of observation). The incidence of pneumonia was 3.2 events/100 patient-years in the FUZEON treatment arm and 1.8 events/100 patient-years in the non-FUZEON treatment arm. The hazard ratio, adjusting for other baseline risk factors, was 1.34 (95% C.I. = 0.90 – 2.00). Based on this observational study, it is not possible to exclude an increased risk of pneumonia in patients treated with FUZEON compared to non-FUZEON treated patients.

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NIAID Scientists Identify Immunization-Generated Antibodies that Help Protect Monkeys from HIV-Like Virus

“Using a monkey model of AIDS, scientists have identified a vaccine-generated immune-system response that correlates with protection against infection by the monkey version of HIV, called simian immunodeficiency virus (SIV). …

“Scientists administered the SIV vaccine to half of the 129 monkeys in this study and a placebo vaccine to the other half. The scientists then gave each monkey up to 12 doses of one of two forms of SIV ... . The vaccine regimen did not protect the monkeys that received one form of SIV, but it reduced the rate of infection by 50 percent in the monkeys that received the other form of the virus. …

“This study provides evidence that neutralizing antibodies are an important part of the immune response needed to prevent HIV infection. The ability of the vaccine regimen to protect monkeys from SIV infection is comparable to the results seen in the RV144 trial with 16,000 adult volunteers in Thailand; RV144 was the first HIV vaccine study to demonstrate a modest protective effect, reducing the rate of HIV infection by 31 percent. The new research also provides an animal model to better understand the immune basis for vaccine protection against lentiviruses, a subclass of viruses that includes HIV and SIV. This knowledge will help guide strategies for the future development of AIDS vaccines.

“The SIV vaccine regimen used in this study was similar to an HIV vaccine regimen currently being tested in humans in the NIAID-funded clinical trial known as HVTN 505.”

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CDC Releases Supplement to the 2009 HIV Surveillance Report

The Centers for Disease Control and Prevention (CDC) recently released the HIV Surveillance Supplemental Report, Volume 16, Number 2: Enhanced Perinatal Surveillance—15 Areas, 2005–2008. The purpose of this report is to describe the population of HIV-infected women who gave birth during 2005–2008, which can provide information for further focusing perinatal prevention efforts in the United States and dependent areas. It is a supplement to the 2009 HIV Surveillance Report.