Background More than 90% of the new HIV infection in China occurred through sexual transmission, particularly among the men who have sex with men (MSM). Cervical cancer, the second most common cancer among women, is caused by sexually acquired infection with high-risk types of HPV, such as types 16 and 18. We previously have shown that a chemically modified bovine milk protein, β-lactoglobulin (3HP-β-LG, also known as JB01), is effective against infection by a broad-spectrum of HIV (Nat. Med., 2:230,1996) and HPV entry inhibitor. Therefore, we intended to develop topical formulations containing JB01 against HIV and HPV infections.
Methods A pseudotyped HPV particles expressing HPV L1 and L2 proteins were used for testing the inhibitory activity of JB01. A randomized open-label clinical trial of a JB01 biological dressing (JB01-BD) administered intravaginally was performed to evaluate its in vivo safety and efficacy. Both pseudotyped and live HIV-1 strains with different subtypes and tropisms were used for evaluating the in vitro efficacy of JB01 and a non-human primate (NHP) model was used for testing the in vivo efficacy of JB01.
Results The trial of JB01-BD administered intravaginally demonstrated that JB01-BD is safe and effective. About 60.5% and 13.5% HPV-positive women in the treatment and non-treatment groups, respectively, became HPV-negative (P < 0.001). In vitro study suggests that JB01 exhibits broad-spectrum antiviral activity against divergent HIV-1 strains, including those resistant to the current antiretroviral therapeutics. Rhesus macaques monkeys pretreated with a topical formulation were protected against rectal challenge with SHIV-SF162P3.
Conclusion JB01-BD is safe and effective against HPV and HIV infections, and was approved by China Food and Drug Administration (CFDA) for treating cervical HPV infection with the potential to reduce morbidity of cervical cancer. A lubricant formulation containing JB01 has recently been approved by CFDA as an auxiliary strategy to prevent sexual transmission of HIV.
Disclosure No significant relationships.
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