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Issue No. 6 | February 12, 2010

News and Features

Norvir (Ritonavir) Product Label Updated with Newly Approved Tablet Information

“On February 10, 2010, FDA approved Norvir (ritonavir) 100 mg Tablets. …

“Unlike the capsule formulation, Norvir tablets must be taken with meals. ...

“Patients who take the 600 mg twice daily soft gel capsule NORVIR dose may experience more gastrointestinal side effects such as nausea, vomiting, abdominal pain or diarrhea when switching from the soft gel capsule to the tablet formulation because of greater maximum plasma concentration (Cmax) achieved with the tablet formulation relative to the soft gel capsule …. Patients should also be aware that these adverse events (gastrointestinal or paresthesias) may diminish as therapy is continued.”

The complete revised label will be available at the FDA Web site.

More information is available:

Study Indicates that Racial and Ethnic Minorities Experience Higher Perinatal HIV Infection Rates

Despite substantial declines in the number of HIV-infected infants in the United States, racial/ethnic minorities, especially African Americans, continue to be most significantly impacted by perinatal transmission. For this analysis, researchers analyzed data on HIV diagnoses among children from 2004 to 2007 in 34 states with longstanding, name-based HIV reporting. The average annual rate of diagnosis of perinatal HIV infection was 2.7 per every 100,000 infants. Even though declines were observed in the annual rate of diagnosis of perinatal HIV infection for both black and Hispanic children, the rate among black children still was approximately 23 times higher than the rate among their white counterparts (12.3/100,000 vs. 0.5) and the rate among Hispanic children was four times higher (2.0) than the rate among their white counterparts. Although black and Hispanic children only accounted for 37 percent of the population under the age of one, these groups represented 85 percent of all perinatal HIV diagnoses (compared to 81 percent of females and 64 percent of males over the age of 13 with HIV diagnoses). Because the risk of transmission from an HIV-infected mother to her child can be greatly reduced with effective interventions, the authors emphasize it is critical all women – especially African Americans and Latinas – have access to HIV prevention, reproductive health care, prenatal care and, if necessary, HIV treatment.”

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Study Suggests Inactivated Mycobacterial Vaccine May Prevent Tuberculosis in Bacille Calmette-Guérin-Primed, HIV-Infected Adults

“The DarDar trial was a randomized, placebo-controlled, double-blind trial. The study was carried [out] in an outpatient facility in Dar es Salaam, Tanzania. HIV-infected patients with CD4 cell counts of at least 200 cells/mul and a Bacille Calmette-Guérin scar were chosen for the study. The intervention was carried out by random 1:1 assignment to five intradermal doses of M. vaccae or placebo. Tuberculin skin tests were performed, and patients with reactions of at least 5 mm were administered isoniazid for 6 months. … Two thousand thirteen individuals were randomized (1006 to M. vaccae, 1007 to placebo) and followed every 3 months for a median of 3.3 years. The trial was terminated early because of slow accrual of cases of disseminated tuberculosis and significant protection against definite tuberculosis. Hazard ratios were disseminated tuberculosis 0.52 (95% confidence interval 0.21-1.34; seven cases in M. vaccae, 13 cases in placebo; log-rank P = 0.16), definite tuberculosis 0.61 (95% confidence interval 0.39-0.96; 33 cases in M. vaccae, 52 cases in placebo; P = 0.03), and probable tuberculosis 1.17 (95% confidence interval 0.76-1.80; 48 cases in M. vaccae, 40 cases in placebo; P = 0.46). Immunization was well tolerated, with no adverse effect on CD4 cell count or HIV viral load, and no increase in the rate of serious adverse events. … Administration of a multiple-dose series of M. vaccae to HIV-infected adults with childhood Bacille Calmette-Guérin immunization is safe and is associated with significant protection against definite tuberculosis. These results provide evidence that immunization with a whole cell mycobacterial vaccine is a viable strategy for the prevention of HIV-associated tuberculosis.”

More information is available: