FDA's evaluation divided common STIs into two groups in relation to their usual routes of sexual transmission.
Group I STIs -- STIs that are sexually transmitted solely either to or from the head of the penis, an area that is covered when a latex condom is used. Group I STIs include HIV/Acquired Immune Deficiency (AIDS), gonorrhea, chlamydia, trichomoniasis, and hepatitis B virus (HBV).
Group II STIs -- STIs that can be transmitted not only through contact with the head of the penis, but also through contact with infected skin outside the area that is covered when a latex condom is used. Group II STIs include HPV, herpes simplex virus (HSV), syphilis, and chancroid.
In the 2005 proposal, FDA concluded that latex condoms, when used correctly and consistently, are effective in reducing the risk of transmission of Group I STIs (70 FR 69102 at 69108). No new data undermine this conclusion and some new studies of particular Group I STIs provide additional support for it. Therefore, FDA's conclusion related to the Group I STIs continues to be that latex condoms when used correctly and consistently are effective in reducing the risk of transmission of group I STIs.
Well-designed studies evaluated prior to the proposed rule show the effect of consistent condom use on reducing the risk of HIV infection (70 FR 69102 at 69107 to 69108). One well-designed study conducted a meta-analysis (where results of all studies selected are pooled and analyzed) of studies of HIV-discordant subjects (where HIV status is known at the outset of the study, and an uninfected partner has sex with an infected partner) and found that condoms were 90 to 95 percent effective in reducing the incidence of new infections when used consistently. Another study was a systematic review of longitudinal studies and found that consistent use of condoms results in at least an 80 percent reduction in HIV incidence. No new systematic reviews of condom effectiveness in reducing the risk of HIV infection have been published since the cut-off for studies considered in formulating FDA's proposed rule. On the basis described in the proposed rule, FDA's conclusion remains that consistent and correct use of latex condoms is highly effective in reducing the risk of HIV infection.
Consistent with the FDA conclusions presented in 2005 (70 FR 69102 at 69108), one systematic review presented in 2006 demonstrated that consistent and correct use of condoms reduces risk of both gonorrhea and chlamydia in men and women (Ref. 9).
As was the case when FDA published its proposed rule, FDA is aware of no systematic reviews of condom effectiveness against HBV infection. Nor were any new epidemiological studies of condom use and HBV infection published during the period of FDA's review for preparation of this final rule. As discussed in the 2005 proposal (70 FR 69102 at 69108), one cross-sectional study showed that correct and consistent condom use was significantly associated with lower prevalence of HBV.
In the 2005 proposal, FDA concluded that latex condoms, when used correctly and consistently, are effective in reducing the risk of transmission of group II STIs. Studies published since December 2004 support, and in the case of HPV, provide additional evidence for, this conclusion, as discussed below.
No new systematic reviews of condoms and HPV infection have been published since December 2004. At the time of the 2005 proposed rule, the clinical data regarding the effect of condom use on reducing the risk of infection with HPV was limited, but two systematic reviews supported the conclusion that correct and consistent use of latex condoms can reduce the rates of genital warts and cervical cancer, the main diseases associated with HPV infection (70 FR 69102 at 69108). Since December 2004, several individual studies have addressed condom use and HPV infection, not only the incidence of HPV-related disease. Of particular note, a longitudinal study of the association of condom use and risk of genital HPV infection found that women who reported consistent condom use for the eight months prior to HPV testing were less likely to acquire a first-time infection of HPV and that women who reported 100 percent condom use in the prior eight months had no cervical squamous intraepithelial lesions detected on their Pap tests (Ref. 10) (hereinafter referred to as ``2006 Winer et al. study''). Another study published since the cut-off for the 2005 proposed rule found a higher prevalence of HPV in women who did not use condoms (Ref. 4). Yet another study published since the 2005 proposed rule demonstrated an association between prolonged HPV infection and less consistent condom use (Ref. 7). These newer studies now support the conclusion that condom use not only reduces the risk of genital warts and cervical cancer, it also reduces the risk of HPV infection itself.
No new systematic reviews of condoms and HSV infection have been published since December 2004. FDA's 2005 conclusions about latex condom effectiveness were based on the 2002 systematic review showing that condom use reduced the risk of HSV-2 infection for women (70 FR 69102 at 69108). A more recent prospective study showed effectiveness of condom use in reducing the risk of HSV infection in men and replicated effectiveness in women (Ref. 8), supporting the findings of the 2002 systematic review and FDA's 2005 conclusions.
As was the case when FDA published its proposed rule, FDA is not aware of any systematic reviews of condom effectiveness against syphilis infection. FDA's 2005 conclusions about latex condom effectiveness were based primarily on the data from two prospective studies, discussed in the preamble to the proposed rule (70 FR 69102 at 9108), that showed condom use provided significant protection against syphilis. More recently, one study evaluated risks of STIs, including syphilis, in female sex workers and found that failure to use a condom was associated with an increased risk of syphilis (Ref. 6). This information continues to support the conclusion made in the 2005 proposal that correct and consistent latex condom use reduces the risk of syphilis.
Chancroid infection is extremely rare in the United States. In 2006, only 33 new cases were reported in the United States. (Ref. 1). As in 2005, when FDA published its proposed rule, FDA knows of no systematic review of condom effectiveness against this STI. No new epidemiological studies of condom use and chancroid infection have been identified. Therefore, FDA's conclusions about latex condom effectiveness toward chancroid remain based on the study discussed in the 2005 proposal that reported that condom use was associated with a significantly reduced risk of genital ulcer disease (presumed to be chancroid) among prostitutes in Kenya (70 FR 69102 at 69108).
In summary, FDA believes that conclusions from the additional studies published in peer-reviewed publications from December 2004 through April 30, 2008, are consistent with FDA's 2005 conclusions about latex condom effectiveness. Newer evidence, such as the systematic review of the effect of condom use on transmission of gonorrhea and chlamydia infections (Ref. 9) and the recent epidemiological studies showing that condom use reduced HPV infection (Refs. 7 and 10), replicate or strengthen the basis for these conclusions.