The Australian Olympic team will be given a new way to fight off the Zika virus: a condom said to be “Zika-proof,” even though the manufacturer’s website states that it has not applied for or received regulatory approval for its claim.
The summer Olympics are scheduled to be held August 5-21 in Rio de Janeiro. Brazil has been the epicenter of the latest outbreak of the Zika virus, which is linked to an alarming rise in birth defects and other neurological and nervous system disorders.
Australian pharmaceutical company Starpharma Holdings Ltd. and marketing company Ansell Limited announced that the Australian team will be given Ansell’s Dual Protect condoms lubricated with Starpharma’s VivaGel lubricant, an antiviral agent the company claims can protect against bad vaginal bacteria, some STDs and, now, Zika.
The virus is primarily transmitted by infected mosquitoes but is also sexually transmitted.
In an early May news release (PDF), the company said VivaGel had shown “potent antiviral activity against the Zika virus in laboratory studies.” The studies reportedly showed “near complete antiviral protection” at concentrations “significantly below that used in the VivaGel condom.”
“Given sexual transmission of Zika virus is of increasing importance,” Starpharma’s chief executive officer, Dr. Jackie Fairley, said in an online statement, “Starpharma is delighted to play a role in supporting Australian athletes as they compete on the world-stage at the Olympic Games in Rio.”
In the same statement, Australian Olympic Team Chief de Mission Kitty Chiller said, “The health and wellbeing of the Team comes first. Our association with Starpharma will provide extra protection for everyone on the Team, and is a common sense approach to a very serious problem we are facing in Rio.”
However, on the Starpharma’s website, the company says it has “not yet applied for or received regulatory certification regarding Zika virus activity of VivaGel.”
Both the Centers for Disease Control and the World Health Organization have advised that athletes regularly use condoms.
“We know nothing about the Australian product,” said Dr. John Brooks, senior medical adviser for the CDC’s Division of HIV/AIDS Prevention. “There is no evidence that the addition of an anti-infective alters the effectiveness of condoms, whether it improves them or makes them less effective.”
Though the only way to be sure you do not get Zika from sexual transmission is by not having sex, the CDC says, couples should always use condoms the right way, from “start to finish, every time you have sex. This includes vaginal, anal, and oral (mouth-to-penis) sex.”
“Condoms work when used consistently and correctly every time,” Brooks said. “The biggest issue for consumers is putting on and taking off the condom properly and using lubricant to ensure it does not tear.”
VivaGel, or astodrimer sodium, is being studied by the FDA as a method to prevent sexual transmission of HIV and herpes simplex 2. Starpharma says it is also effective against human papillomavirus.
VivaGel, created by nanotechnology, is applied to the vagina or rectum as a pre-exposure prophylaxis (PrEP) product. In the case of HIV, it works by keeping the virus from attaching to susceptible healthy cells.
Laboratory results showed potent antiviral activity against HIV 1 and HIV 2 for at least three hours post-dose, but two 2011 randomized trials found that twice daily use for two weeks caused irritation and low-grade inflammation, which researchers suggest might counter some of the anti-viral effects.
In 2014, the FDA granted approval for a phase three clinical trial of the gel for the treatment of bacterial vaginosis, the most common vaginal infection in women ages 15 to 44. It happens when bad bacteria overtake good bacteria in a woman’s vagina. It’s not a sexually transmitted disease, but it can increase the risk of getting an STD.
Starpharma says it is marketing VivaGel BV in the European Union as a seven-day treatment for bacterial vaginosis while phase three trials continue in the United States.