FDA Approves Second-Generation Female Condom
"On Wednesday, Female Health Co. said the Food and Drug Administration has approved its new FC2 Female Condom. The approval 'is an important development in efforts to deliver affordable access to woman-initiated HIV prevention in the United States and around the world,' said Mary Ann Leeper, a strategic adviser to the company.
"Female Health's first female condom debuted in 1993. Though approved to prevent STDs and pregnancy, it has not gained wide acceptance among US consumers, in part due to its cost - around $2.80 to $4 per condom, compared to male condoms' cost of as little as 50 cents each.
"The FC2 condom is made using a less expensive process that should lower its price, Female Health said, though it is not yet clear how much the FC2 will cost or when it will be available. Female Health has previously said it would like to partner with another company to help market the condom."
Study: AIDS-Defining Events Have a Variable Impact on People Taking HAART
"The extent to which mortality differs following individual acquired immunodeficiency syndrome (AIDS)-defining events (ADEs) has not been assessed among patients initiating combination antiretroviral therapy....We analyzed data from 31,620 patients with no prior ADEs who started combination antiretroviral therapy....During a median follow-up period of 43 months (interquartile range, 19-70 months), 2880 ADEs were diagnosed in 2262 patients; 1146 patients died.... In the combination antiretroviral therapy era, mortality rates subsequent to an ADE depend on the specific diagnosis. The proposed classification of ADEs may be useful in clinical end point trials, prognostic studies, and patient management."
Study: Response-Guided Therapy for Hepatitis C is Possible in Patients Coinfected with HIV
"To study the feasibility of a response-guided therapy for chronic hepatitis C virus (HCV) infection in patients coinfected with human immunodeficiency virus (HIV) in a tertiary care hospital.... Treatment duration was individualized on the basis of week 4 and week 12 virologic response....Overall, 33 (55%) of 60 patients achieved a sustained virologic response....A response-guide therapy is feasible and may be useful to optimize the individual outcome of HCV treatment in patients coinfected with HIV."