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• Investigational Study with GARDASIL, Data Presented on Reduction in Abnormal Pap Tests and Cervical Procedures in Women Naïve to Multiple HPV types
In one study presented at the congress, which involved an extended follow up of 290 women, the vaccine was effective against HPV-16 infection for an average of 8.5 years after administration. Worldwide 70% cervical cancer is caused by strains 16 and 18 of HPV and this study provides further evidence for long-term effectiveness of the HPV vaccine, Gardasil. Dr Laura A. Koutsky, University of Washington, School of Public Health in USA led this extension study.
In a different study of 17,622 women 16 to 26 yr, who were vaccinated with Gardasil, Gardsail reduced the number of abnormal Pap smear test results by 17-45%, and reduced colposcopies (medical procedure that allows examination of cervix more closely) by 20%, cervical biopsies by 22% and reduced surgery and other invasive treatments by 42%.
In terms of effectiveness in males, GARDASIL also reduced HPV types 6/11/16/18-related external genital lesions by 90.4% and persistent infection by 85.6% in a study of 4065 uninfected men aged 16 to 26 years. In an additional study of males aged 16 to 26 years of age, GARDASIL produced an immune response against HPV that was equivalent to the immune response demonstrated in women.
Dr. Saad Ghazal-Aswad, MD, Sr. Consultant Gynecological Oncologist, Tawam Hospital, said: "These results are very encouraging, especially the extended effectiveness data for Gardasil.
Other long-term studies to investigate the effectiveness further are already underway. Gardasil data up to 8.5 years is extremely important and ensures the long-term clinical effectiveness of this vaccine. It's important to note that clinical endpoints is hallmark of efficacy for any vaccine"
Dr.Muna Abdulrazzaq Tahlak, FACOG, and Consultant OBGYN Al Wasel Hospital - DOHMS, said:
"Cervical cancer is the second common cancer among women and the leading cause of morbidity and mortality. Currently, 5 per 100,000 women in the Middle East and 9 per 100,000 in the UAE are affected by cervical cancer. It is great news that the Gardasil vaccine continues to prove its protective benefits in women against this form of cancer."
Gardasil is approved in 109 countries worldwide, and indicated for the prevention of cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous lesions caused by HPV types 6, 11, 16 and 18. HPV types 6 and 11 are responsible for approximately 90% of genital warts and about 10% of low-grade cervical changes or lesions.
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Posted by Rima Ali Al Mashni
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