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Oral Lopinavir Use and Human Papillomavirus Infection in HIV-Positive Women

Invasive cervical cancer (ICC) is the third most common female malignancy and fourth most common cause of cancer death in women globally1. The risk of ICC is several-fold higher in HIV-positive women than in HIV-negative women, as are the prevalence2–5, incidence, and persistence of oncogenic human papillomavirus (oncHPV)6–14, the infectious cause of most ICC. Although use of effective highly-active antiretroviral therapy (HAART) has been associated with reduced oncHPV prevalence and incidence15 and increased regression of cervical lesions16–19, the overall incidence of ICC has not decreased in HIV-positive women during the HAART era. By increasing survival, HAART may increase lifetime oncHPV infections, allowing accumulation of somatic mutations and epigenetic changes necessary for oncogenesis. Currently, no anti-viral medications are clinically approved to treat cervical HPV infections. 
 
In vitro studies have shown that lopinavir (LPV), an HIV-1 protease inhibitor (PI) used in some HAART regimens, may have activity against oncHPV through inhibition of viral oncogene E620, 21. Most recently, an early phase clinical trial conducted in Nairobi, Kenya studied topical application of LPV to the cervix; preliminary results showed that 21 of 23 women initially diagnosed with high-grade disease returned to normal on subsequent Papanicolaou (Pap) smears and showed visible regression of cervical lesions22. 
 
We therefore assessed the hypothesis that oral LPV use may be associated with decreased prevalence and increased clearance of oncHPV compared to other antiretroviral (ARV) regimens.