Until Január 31, 2012, the four-component HPV vaccine is available for 15,900 Ft per ampoule, instead of the usual 30,000 Ft. Preliminary HPV screening and cytological exam are also available.
Silgard is a vaccine. It is a suspension for injection that contains purified proteins from four types of the human papillomavirus (types 6, 11, 16 and 18).
Silgard is used to vaccinate against precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina), cancer of the cervix and genital warts that are caused by infection with the human papillomavirus (HPV) types 6, 11, 16 or 18.The effectiveness of Silgard has been studied in women aged 16 to 26 years, and its immunogenicity (its ability to make the immune system respond to the viruses) has been studied in children and adolescents aged nine to 15 years. Its protective effectiveness has not been studied in males. Silgard is given according to official recommendations. The medicine can only be obtained with a prescription.
Silgard is given to individuals aged nine years or over, as three doses, with two months between the first and second doses, and four months between the second and third doses. If a different schedule is needed, there should be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year. It is recommended that individuals who receive the first dose of Silgard should complete all three doses with Silgard. The vaccine is given as an injection into a muscle, preferably in the upper arm or the thigh.
Papillomaviruses are viruses that cause warts and abnormal tissue growth. There are more than 100 types of papillomavirus, some of which are associated with genital cancers. HPV types 16 and 18 cause approximately 70% of cervical cancers and HPV types 6 and 11 cause approximately 90% of genital warts.
All papillomaviruses have a shell, or ‘capsid’, that is made up of proteins called ‘L1 proteins’. Silgard contains the purified L1 proteins for four of the types of human papillomavirus: types 6, 11, 16, and 18. The proteins in Silgard are produced by a method known as ‘recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the L1 proteins. They are assembled in ‘virus-like particles’ (structures that look like HPV, so that the body can recognise them easily).The vaccine also contains an ‘adjuvant’ (a compound containing aluminium) to stimulate a better response.
When a patient is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these proteins. The antibodies help to block the virus from entering cells in the body. After vaccination, the immune system is able to produce antibodies quickly when it is exposed to the real viruses. This will help to protect against the diseases caused by these viruses.
The effects of Silgard were first tested in experimental models before being studied in humans. The four main studies in humans involved almost 21,000 women aged between 16 and 26 years. Silgard was compared with placebo (a dummy vaccine). The studies looked at how many women developed genital lesions or warts that were due to HPV infection. The women were followed up for around three years after the third dose of the vaccine.
Silgard was effective against precancerous genital lesions of the cervix, vulva and vagina, cervical cancer, and warts related to HPV types 6, 11, 16 and 18. Looking at the results of all four studies together, in women who had never been infected by HPV types 6, 11, 16 or 18 before, and who received the full course of vaccination, one woman out of over 8,000 vaccinated with Silgard developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18. In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types. A similar effect of Silgard was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
For external genital lesions due to HPV types 6, 11, 16 or 18 (including warts and precancerous lesions of the vulva or the vagina), the results of three of the studies were looked at together. Two women out of almost 8,000 in the Silgard group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina. In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were pyrexia (fever) and reactions at the site of the injection (redness, pain and swelling). For the full list of all side effects reported with Silgard, see the Package Leaflet.
Silgard should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients. If a patient shows signs of an allergy after a dose of Silgard, she should not receive further doses of the vaccine. Vaccination should be postponed in patients who are ill with a high fever.
The Committee for Medicinal Products for Human Use (CHMP) decided that Silgard’s benefits are greater than its risks as a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to HPV types 6, 11, 16 and 18. The Committee recommended that Silgard be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union for Silgard to Merck Sharp & Dohme Ltd. on 20 September 2006.