AIDS Resources (cont'd)

Gardasil is a recombinant vaccine (contains no live virus) that is given as three injections over a six-month period.  Immunization with Gardasil is expected to prevent most cases of cervical cancer due to HPV types included in the vaccine.  However, females are not protected if they have been infected with that HPV type(s) prior to vaccination, indicating the importance of immunization before potential exposure to the virus.  Also, Gardasil does not protect against less common HPV types not included in the vaccine, thus routine and regular pap screening remain critically important to detect precancerous changes in the cervix to allow treatment before cervical cancer develops.    

"This is the first vaccine licensed specifically to prevent cervical cancer.  Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible.  Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults," said Jesse Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research.

Four studies, one in the United States and three multinational, were conducted in 21,000 women to show how well Gardasil worked in women between the ages of 16 and 26 by giving them either the vaccine or placebo.  The results showed that in women who had not already been infected, Gardasil was nearly 100 percent effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed.  While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.

The studies also evaluated whether the vaccine can protect women already infected with some HPV types included in the vaccine from developing diseases related to those viruses.  The results show that the vaccine is only effective when given prior to infection.

Two studies were also performed to measure the immune response to the vaccine among younger females aged 9-15 years.  Their immune response was as good as that found in 16-26 year olds, indicating that the vaccine should have similar effectiveness when used in the 9-15 year age group.

The safety of the vaccine was evaluated in approximately 11,000 individuals.  Most adverse experiences in study participants who received Gardasil included mild or moderate local reactions, such as pain or tenderness at the site of injection.   

The manufacturer has agreed to conduct several studies following licensure, including additional studies to further evaluate general safety and long-term effectiveness.  The manufacturer will also monitor the pregnancy outcomes of women who receive Gardasil while unknowingly pregnant.   Also, the manufacturer has an ongoing study to evaluate the safety and effectiveness of Gardasil in males. 

Gardasil is manufactured by Merck & Co., Inc., of Whitehouse Station, NJ. 

For more information, see:      http://www.fda.gov/cber/products/hpvmer060806.htm.
                                http://www.fda.gov/womens/getthefacts/hpv.html

Adult Treatment Guidelines Updated
The Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents has been revised to include up-to-date treatment information, including new recommendations for resistance testing, treatment interruption, and HBV/HIV co-infection. Tables have been revised to include up-to-date information about drug interactions and about the lopinavir/ritonavir 200/50 mg tablet formulation. Changes to the document are summarized in the "What's New in the Document?" section, and all changes to the document are highlighted in yellow throughout the text.

The updated guidelines document is available in the ADULT GUIDELINES section of the GUIDELINES page on the www.AIDSinfo.nih.gov web site. The site also contains an option to order hard copies of the guidelines or request an electronic copy by e-mail.

AIDSinfo is also a useful source of other information related to HIV/AIDS, including other treatment and prevention guidelines, downloadable databases for PDAs (Personal Digital Assistants), and HIV/AIDS-related clinical trials information.

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