Adverse events are minimal
The most common systemic vaccine-related adverse events reported in all the trials were headache and fatigue, which were noted in 50% to 60% of participants. The most common serious adverse events were abnormal pregnancy outcomes, such as birth defects and spontaneous abortion, but the RR of 1.0 for all serious adverse events suggests a statistically insignificant difference in the risk of serious adverse events between vaccine and control groups. These findings are consistent with the most recent review by the CDC and FDA (October 2010), which concluded that Gardasil is safe and effective for the prevention of the four types covered in the vaccine.2 CDC updates on safety do not yet include the bivalent vaccine because of its more recent release to the US market.
WHAT THIS EVIDENCE MEANS FOR PRACTICE
At every opportunity, encourage HPV vaccination for girls and women who are 9 to 26 years old.
New STD guidelines from the CDC include tips
on cervical cancer screening
Workowski KA, Berman S; Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep. 2010;59(RR-12):1–110.
The CDC’s most recent sexually transmitted disease (STD) guidelines, released at the end of 2010, cover all sexually transmitted infections, including genital HPV infection. In general, the recommendations on cervical cancer screening are consistent with ACOG’s 2009 guidelines, which I discussed in the March 2010 Update on Cervical Disease. The CDC also offers concrete, useful suggestions on how to counsel patients who have genital warts or who test positive for an oncogenic strain of HPV. Although the guidelines are aimed at STD and public health clinics, they include many recommendations useful to all health care providers. For that reason, discussion of the highlights seems appropriate.
Like ACOG, CDC says screening should start at 21 years
Screening should begin when the patient is 21 years old and continue at 2-year intervals until she is 30 years old, at which time it should switch to every 3 years—provided she has had three consecutive normal Pap tests or one normal cotest (Pap and HPV test combined).
Because a woman may sometimes assume that she has undergone a Pap test by virtue of having had a pelvic examination, inaccuracies in self-reported screening intervals may arise. Therefore, it is imperative to devise a protocol for cervical cancer screening among women who do not have documentation, in their medical record, of a normal Pap test within the preceding 12 months. Although some women will undoubtedly undergo screening sooner than necessary, this approach will protect women lacking adequate documentation from being underscreened.
When to use the HPV test (and when to avoid it)
The guidelines confirm that the HPV test is an appropriate tool in the management of atypical squamous cells of undetermined significance (ASC–US) among women 21 years and older and as a cotest with the Pap for women who are 30 years and older.
The CDC recommends against the HPV test in the following situations:
- when deciding whether to vaccinate against HPV
- as part of a screen for STD
- in the triage of low-grade squamous intraepithelial lesion (LSIL) Pap results, although 2006 guidelines from the American Society for Colposcopy and Cervical Pathology and 2007 guidelines from ACOG recommend, as an option, the use of the HPV test in the triage of postmenopausal women who have LSIL
- in women younger than 21 years
- as a stand-alone primary cervical cancer screen (without the Pap test).
These recommendations are consistent with earlier conclusions.3
How to counsel women about their HPV test results
Perhaps the most important insights offered in the CDC’s 2010 STD guidelines are the counseling messages for women who undergo cotesting with both the HPV and Pap tests. It often is a challenge to communicate the indications for and findings of this screening approach. Here is guidance offered by the CDC:
- HPV is very common. It can infect the genital areas of both men and women. It usually has no signs or symptoms.
- Most sexually active persons get HPV at some time in their life, although few will ever know it. Even a person who has had only one lifetime sex partner can get HPV if the partner was infected.
- Although the immune system clears HPV infection most of the time, the infection fails to resolve in some people
- No clinically validated test exists for men to determine whether they have HPV infection. The most common manifestation of HPV infection in men is genital warts. High-risk HPV types seldom cause genital warts.
- Partners who are in a long-term relationship tend to share HPV. Sexual partners of HPV-infected people also likely have HPV, even though they may have no signs or symptoms of infection.
- Detection of high-risk HPV infection in a woman does not mean that she or her partner is engaging in sexual activity outside of a relationship. HPV infection can be present for many years before it is detected, and no method can accurately confirm when HPV infection was acquired.