Skipping Doctor Visits Risky for HIV Patients, Old Drugs Might Give TB a 1-2 Punch, J & J Seeks Full Approval for Intelence

April 2, 2009

The death rate for HIV-infected patients who miss scheduled clinic appointments during their first year of treatment is more than double that for patients with perfect attendance, according to a recent study (Douglas D. Reuters Health. February 11, 2009).

Skipping Doctor Visits Risky for HIV-Infected Patients
The death rate for HIV-infected patients who miss scheduled clinic appointments during their first year of treatment is more than double that for patients with perfect attendance, according to a recent study (Douglas D. Reuters Health. February 11, 2009).

Dr Michael J. Mugavero and colleagues at the University of Alabama at Birmingham studied 543 patients who began outpatient HIV care at the school's 1917 HIV/AIDS Clinic between 2000 and 2005. Of the patients, 60% missed an office visit in the first year of treatment. Even after controlling for immune system function at the outset and HIV drug therapy in that first year, the mortality rate for patients who made all scheduled visits was 1 per 100 person-years, compared with 2.3 per 100 person-years in those who missed appointments. Furthermore, the increased risk of death was similar when patients missed only 1 visit or 2 or more visits.

"Considering tens of thousands of individuals are newly diagnosed with HIV infection in the United States annually, and the high frequency of missed visits in the first year of care-which was associated with over a 2-fold increase in mortality in our study-extrapolation of our findings to the general population level has profound public health implications," said Mugavero.

"For HIV care providers, missed visits shortly after establishing outpatient care serve as a marker identifying patients at higher risk for poor clinical outcomes-patients who may require closer monitoring," Mugavero added.

The study report was published in Clinical Infectious Diseases (Mugavero MJ, Lin HY, Willig JH, et al. Missed visits and mortality among patients establishing initial outpatient HIV treatment. Clin Infect Dis. 2009;48:248-256). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Thursday, February 12, 2009]

Old Drugs Might Give TB a 1-2 Punch
A fresh approach to tuberculosis (TB) treatment using 2 old, safe antibiotics could fight even the deadliest strains of Mycobacterium tuberculosis-extensively drug-resistant M tuberculosis (XDR-TB)-a new report suggests (Neergaard L. Associated Press. February 26, 2009).

M tuberculosis organisms contain an enzyme, β-lactamase, that disables the penicillin class of antibiotics. "It chews them up and spits them out and they never get to see their target," said John Blanchard of the Albert Einstein School of Medicine. However, other antibiotics can block b-lactamase, and Blanchard's team tried using this enzyme-blocking property to flank M tuberculosis, hoping to open it up to a wider spectrum of antibiotic susceptibility. Researchers specifically tapped the antibiotic clavulanate, part of the 2-drug Augmentin antibiotic widely used for various children's infections, to inhibit the M tuberculosis enzyme.

In the laboratory, clavulanate opened M tuberculosis up to meropenem, an antibiotic in the same class as penicillin, and the combination blocked the growth of 13 different XDR-TB strains. Trials may soon answer whether the combination will work in humans. US researchers from the NIH and New York's Montefiore Medical Center are planning small patient studies in South Korea and South Africa, which they hope to begin later this year.

"It's very clever," said Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. The 1-2 treatment punch "leaves the original drug with the capability of doing what it's supposed to do."

The full report was published in Science (Hugonnet JE, Tremblay LW, Boshoff HI, et al. Meropenem-clavulanate is effective against extensively drug-resistant Mycobacterium tuberculosis. Science. 2009;323:1215-1218). [CDC HIV/Hepatitis/STD/TB Prevention News Update, Tuesday, March 3, 2009]

Johnson & Johnson Seeks Full FDA Approval for Intelence
Johnson & Johnson's Tibotec unit is requesting full (FDA approval for its HIV drug Intelence, an NNRTI designed for patients who have stopped responding to other treatments (Associated Press. February 5, 2009). In January, the FDA gave the drug preliminary approval under its accelerated approval program, allowing the company to market Intelence. In order to gain full approval, the FDA required Tibotec to supply follow-up data on the drug's effectiveness. According to data submitted by Tibotec, 60% of patients who were taking Intelence for 4 months had undetectable HIV levels in their blood, compared with 39% of patients who were taking a placebo. [CDC HIV/Hepatitis/STD/TB Prevention News Update, Friday, February 13, 2009]