A Northwestern University (NU) researcher has come up with a device that could change women’s reproductive health in a significant way–an intravaginal ring that delivers antiviral protection against HIV and herpes and contraceptives to protect against pregnancy.
The study was published in the peer-reviewed, open-access online journal, PLoS One this month.
NU biomedical engineer Patrick Kiser says the dual-reservoir intravaginal ring, that is easily inserted in the vagina, delivers the HIV-1 reverse transcriptase inhibitor tenofovir and the contraceptive levonorgestrel for 90 days.
The rings are being manufactured now, and the device soon will undergo its first test in women.
“I suspect women will use the ring primarily for contraception, but they also will benefit from protection against sexually transmitted diseases,” said Kiser, an expert in intravaginal drug delivery. “And for women in the developing world in particular, unwanted pregnancy can have significant health, economic and cultural consequences. We want to motivate women to use this ring.”
The Segmented Dual-Reservoir Polyurethane Intravaginal Ring was five years in the making and is described as both simple and complex. “A lot of engineering has gone into developing the ring,” said Kiser, senior author of the paper. “It represents two Ph.D. theses — one Ph.D. for the larger section containing the antiretroviral drug and another Ph.D. for the smaller section containing the contraceptive.”
The strength of the device stems from its unique polymer construction: its elastomer swells in the presence of fluid (such as that found in the human body), delivering up to 100 times more of the tenofovir than current intravaginal ring technology, which have release rates that decline over time.
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In an interview on RadioMD, Dr. Meredith Clark, PhD, Head of drug delivery at CONRAD said the the clinical studies on the use of the ring is to start in 2014. It is designed to be safe, effective and affordable.
She says that not all women have control over the use of a condom, the intravaginal ring would help empower them to protect themselves.
In addition, Clark say the ring is “intended to be user friendly–you put it in and forget about it. Three months later you take it out and you put another in.”
The co-delivery of two drugs as physicochemically diverse as tenofovir and levonorgestral and at such different release rates, sustained for 90 days, demonstrates the adaptability of this dual-reservoir polyurethane technology. The platform is easily configured to deliver other drugs and a wide range of doses or combinations for other women’s heath challenges.
Genital herpes encompasses herpes simplex viruses type 1 (HSV-1) or type 2 (HSV-2) and the CDC says that more than 24 million people have new and existing HSV-2 infections. There are about three-quarters of a million new HSV-2 infections annually.
Nationwide, 16%, or about one out of six, people aged 14 to 49 years have genital HSV-2 infection.
Although HSV-2 seroprevalence is decreasing, most persons with HSV-2 have not received a diagnosis.
There is no treatment that can cure herpes. Antiviral medications can, however, prevent or shorten outbreaks during the period of time the person takes the medication. In addition, daily suppressive therapy (i.e., daily use of antiviral medication) for herpes can reduce the likelihood of transmission to partners.
There are approximate 908,000 new and existing HIV infections in the United States with an estimated 40,000 new cases reported annually.
While great progress has been made in preventing and treating HIV, HIV and AIDS remain a persistent problem for the United States and countries around the world.
Although there is currently no safe and effective cure at present, with proper medical care, HIV can be controlled. Treatment for HIV is often called antiretroviral therapy or ART. It can dramatically prolong the lives of many people infected with HIV and lower their chance of infecting others.
About 18,000 people die from AIDS annually in the US.
In addition to the human toll, STIs carry with it a huge economic burden. The CDC conservatively estimates that the lifetime cost of treating eight of the most common STIs contracted in just one year is $15.6 billion.
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