Transcript What is HPV?

What is HPV?
Estimated to be the most common sexually transmitted
infection in the United States.
A human papillomavirus (HPV) is a virus that
infects the epidermis and mucous
membranes.
• Over 130 HPV Types
• Lifecycle somewhat unknown.
• Several months to years may elapse before the abnormal growth of cells
• Worldwide there are 490,000 cases of
cervical cancer
• 270,000 deaths
• HPV types 16 and 18 cause 70% of cervical
cancer cases.
• HPV causes approximately 25% of cancers
of the mouth and upper throat.
Early Detection?
• Pap smear
• Abstinence
• Condoms
• Research began in the 80s
• 1993-US National Cancer Institute was
able to generate HPV-16 virus like
particles leading to the Gardasil
vaccine.
• Two HPV vaccines are currently on the
market, Gardasil and Cervarix
– Both vaccines protect against two of the HPV
types (HPV-16 and HPV-18) that can cause
cervical cancer.
– Gardasil also protects against two of the HPV
types that cause genital warts (types 6 and
11).
• Gardasil is a 3 dose
(injection) vaccine.
• There have been 50 million
doses distributed in the
United States, and there have
been 13,758 Vaccine
Adverse Event Reportings.
• 93% non-serious
– Fainting, pain and swelling at
the injection site, headache,
nausea and fever
• 7% considered to be serious
– Death, permanent disability, lifethreatening illness and
hospitalization
Long Term Effects
• The vaccines have been shown to offer 100% protection
against the development of cervical pre-cancers and
genital warts caused by the HPV types in the vaccine,
with few or no side effects.
• The protective effects of the vaccine are expected to last
a minimum of 4.5 years after the initial vaccination.
• While the study period was not long enough for cervical
cancer to develop, the prevention of these cervical
precancerous lesions (or dysplasia) is believed to result
in the prevention of those cancers.
NEW EVIDENCE
• First introduced for women 25 years old or
younger.
• In November 2007, Merck presented new
data on Gardasil.
– Reduced infection of HPV 6, 11, 16, 18 in
women through the age of 45.
So what about males?
• Males can carry HPV and transmit it sexually to
their partners.
• HPV can also cause genital warts, penile and
anal cancer in men.
• HPV more commonly causes genital warts in
men; each year, about 200 out of 100,000 males
are newly diagnosed with genital warts.
• Clinical trials presented to the Advisory
Committee evaluated the efficacy and
safety of Gardasil in boys and men 9 to 26
years of age.
• Efficacy was evaluated in a randomized,
double-blind, placebo-controlled trial.
• A 2005 study in San Francisco found that 95 percent of
HIV-infected gay men also had anal HPV infection, of
which 50 percent had precancerous HPV-caused lesions.
•A Merck study of 4,000 boy’s ages 16 to 26 showed Gardasil to be effective in
preventing 90 percent of cases of penile cancer and genital warts, caused by the same
four strains of HPV that currently cause 70 percent of cases of cervical cancer.
On a scale of 1 to 6, with one representing no interest in getting vaccinated for
HPV and six representing a high interest in getting the vaccine, the average
score of the men was about 3.9.
However, when informed that the vaccine could protect their partners from
cervical cancer, their average interest in being vaccinated did not increase
• The overall prevalence of HPV was 65.4%.
• HPV detection was highest at the penile shaft,
followed by the scrotum (34.2% and 32.8%).
• Detection was lowest in semen samples: 5.3% and
4.8%.
• As of October 16, 2009, The U.S. Food and Drug
Administration approved the use of the vaccine Gardasil for
the prevention of genital warts due to human papillomavirus
(HPV) types 6 and 11 in boys and men, ages 9 through 26.
As of today, Merek is still working on the
commercialization and distribution of the vaccine to
healthcare providers.