Last year, Helen Koenig, MD
, an infectious disease expert at Penn Medicine, met a married couple faced with an uncommon fertility challenge they wanted to safely overcome.
The husband is HIV positive and the wife is not, so to achieve their dreams of having a family, they pursued in vitro fertilization (IVF) and a technique known as “sperm washing” to keep her and their baby free of infection. They visited Koenig to ensure the antiretroviral drugs made it so the virus was still undetectable, an extra precaution taken before washing.
Deemed "clear," the couple was prepared to move forward when Koenig suggested another option they hadn't considered: pre-exposure prophylaxis, commonly known as PrEP.
The oral daily pill was first recommended by the U.S. Centers for Disease Control and Prevention (CDC) in 2014 for people who do not have HIV, but are considered “high-risk,” after numerous studies showed how successful the drug was at preventing infections.
Koenig laid out the details for the couple: He would continue to take his antiretroviral drugs. She would go on PrEP to protect herself. And they would then try to conceive naturally, she explained.
“Plenty of patients have conceived beautiful, healthy, HIV-negative babies in the context of PrEP,” said Koenig, an associate professor of Medicine. “We call it PrEP-ception.”
Every day, 400 babies are born HIV positive around the world, but with newer technologies and discoveries, having healthy, HIV-free children has become a reality for more couples around the world.
IVF and intrauterine insemination (IUI) have been the gold standard to help so-called discordant couples conceive because of the success rates, particularly with IVF, but over the last few years PrEP has become an enticing alternative for some.
It’s safe and cheaper than IVF or IUI. Studies have shown the drug is 99 percent effective at preventing HIV infection when a person adheres to the medication. IVF plus sperm washing can cost over $20,000, while most insurance companies will cover PrEP.
When the CDC first addressed the issue, none of these options were available. "[N]o data exist to support the safety of any procedure purported to remove HIV from semen,” a 1990 CDC Morbidity and Mortality Weekly Report (MMWR) stated. "The CDC recommends against insemination with semen from HIV-infected men."
Twenty-seven years and a slew of new advances and evidence later, the CDC officially reversed its recommendations on the matter.
“The risk for transmission from an HIV-infected man to an HIV negative woman is low if appropriate risk-reduction strategies, such as the use of highly active antiretroviral drugs, antiretroviral pre-exposure prophylaxis, and sperm washing, are implemented,” the CDC wrote in a MMWR early this month.
Some of these approaches have been in practice for the last 15 years, but the CDC had not given this seal of approval until now.
Sperm washing, in which the spermatozoa are removed from the HIV-infected semen, has had an excellent record in discordant couples. A meta-analysis of 40 studies published in the journal Fertility and Sterility in 2016 found zero transmissions of HIV from 11,585 sperm washing procedures before IVF or IUI in almost 4,000 women.
While the CDC does note that sperm washing in men who are taking HIV meds before IVF or IUI and in conjunction with a partner on PrEP helps reduce the risk of infection even more, many studies have shown that the risk is still very low when the man is only on antiretroviral drugs. It's 0.16 out of 10,000 exposures.
The washing and IVF are recommended added precautions to lower the risk as much as possible. It's like creating safety nets for safety nets. Taking PrEP is no different, Koenig said.
"It has become clear from the data that PrEP is a very reasonable approach to conception,” said Clarisa Garcia, MD, MSCE, director of Fertility Preservation and associate professor of Obstetrics and Gynecology, who’s working with Koenig to revise Penn’s fertility guidelines. "IVF is no longer considered standard for discordant couples without a fertility problem."
The virus can affect a man’s sperm quality and quantity, so approaches like IVF or IUI will likely always play a role for some discordant couples having trouble conceiving.
Because it’s still early days for PrEP, it's unclear how many couples have taken it as part of their fertility treatment. Koenig has treated about 10 couples over the past year, three of whom ended up conceiving babies, all HIV negative.
The husband and wife she first met with last year ultimately decided to go on PrEP, as well.
“I think anecdotally PrEP works as well for these couples as you would expect based on what’s been shown in studies. And it easily rivals the IVF data – which is why I think a lot of the guidelines treating these patients are beginning to change,” Koenig said. “It also provides a more practical choice because sperm washing and IVF are not an option for a lot of patients.”