05/20/10

PRN Report: Quadrivalent HPV Vaccine is Safe & Effective in HIV-Positive & HIV-Negative MSM

New data show that the quadrivalent HPV vaccine is safe and effective in HIV-positive and HIV-negative men who have sex with men (MSM).

Although the quadrivalent HPV vaccine (active against HPV types 6, 11, 26 and 18) is presently FDA-approved only for prevention of external genital lesions in boys and young men, Dr Stephen Goldstone presented new data at the May 18th PRN meeting in NYC showing that the vaccine also prevents both intra-anal and perianal condyloma and dysplasia in MSM.

In HIV-negative MSM, the quadrivalent HIV was highly efficacious not only in reducing the incidence of external genital lesions in men aged 16 to 26 years, but also preventing AIN 1, 2 and 3 related to HPV in MSM subjects naïve to vaccine HPV types at enrollment. Furthermore, efficacy was seen against AIN1, condyloma , AIN 2, AIN 3 in both the per protocol and the full analysis populations, and vaccine was generally well tolerated.

In HIV-infected men, no serious adverse events related to vaccination were noted. Of particular importance, there were no untoward effects of the HPV vaccine on CD4+ cell counts or plasma HIV RNA levels. The quadrivalent HPV vaccine was shown to be highly immunogenic in HIV-positive men.

Seroconversion in HIV-positive men was much higher for the quadrivalent HPV vaccine than has been reported with other recombinant protein vaccines, such as HAV and HBV vaccines. For HIV-positive MSM negative for HPV antibodies at baseline, the seroconversion rates were greater than 95% for each of the four HPV types. The vaccine also provided a generous boost in titers for those with HPV antibodies at baseline.

HPV antibody titers in HIV-positive MSM were comparable to those seen in HIV-negative MSM, but lower than those reported in studies of HIV-negative heterosexual men and women.

It is encouraging that most insurance companies are now paying for this vaccine in boys and men, as they do for women. Dr. Goldstone emphasized that efficacy studies in HIV-infected men and women over the age of 26 should now be pursued.

Reference: Stephen E. Goldstone, MD FACS (Assistant Clinical Professor of Surgery, Mount Sinai School of Medicine, New York, NY). Quadrivalent HPV vaccine in HIV-positive and HIV-negative men who have sex with men. Presented at the May 18, 2010 meeting of the Physicians’ Research Network (PRN); New York, NY.

Source: Reporting from New York City for PRN News: Jim Braun, DO