Updated Interim Zika Clinical Guidance for Reproductive Age Women and Men, Sexual Transmission of Zika, and the U.S. Zika Pregnancy Registry

NOTE: This transcript has not been reviewed by the presenters and is made available solely for your convenience. A final version of the transcript will be posted as soon as the presenter’s review is complete. If you have any questions concerning this transcript, please send an email to coca@cdc.gov

Coordinator:       
Welcome and thank you for standing by. At this time all participants are in a listen-only mode. During the question and answer session please press Star 1 and record your name as prompted. Today’s conference is being recorded if you have any objections you may disconnect at this time. I would now like to turn today’s meeting over to Will Koehne. Thank you. You may begin.

Will Koehne:       
Thank you Carolyn. Good afternoon. I’m Will Koehne and I'm representing the Clinician Outreach and Communication Activity, COCA with the Emergency Risk Communications Branch at the Centers for Disease Control and Prevention. I'm delighted to welcome you today to COCA's call, Updated Interim Zika Clinical Guidance for Re-Reproductive Age Women and Men Sexual Transmission of Zika and the U.S. Zika Pregnancy Registry.

You may participate in today’s presen-presentation by audio only via Webinar or you may download the slides if you are unable to access the Webinar. The PowerPoint slides set and the Webinar link can be found on our COCA Web page at emergency.cdc.gov/coca. Click on April 12th COCA call. The slide set is located under Call Materials. Free continuing education is offered for this COCA called. Instructions on how to earn continuing education will be provided at the end of the call.

CDC, our planners, presenters and their spouses' partners wish to disclose that they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services or commercial supporters. Planners have reviewed the content to ensure there is no bias. This presentation will not include any discussion of the unlabeled use of a product or products under investigational use.

At the end of the presentation you will have the opportunity to ask the presenters questions. Additional CDC subject matter experts will be standing by to assiss- assist in answering your questions. On the phone, dialing Star 1 will put you in the queue for questions. You may submit questions through the Webinar at any time during the presentation by selecting the Q&A Tab at the top of the Webinar screen and typing in your question.

Questions are limited to clinicians who would like information on Zika virus and Zika virus disease. For those who have media questions please contact CDC Media Relations at 404-639-3286 or send an email to media@cdc.gov. If you are a patient please refer your questions to your healthcare provider.

Today’s first presenter is Dr. Christine K. Olson. Dr. Olson is a Medical Officer in the Preterm and Infant Health Team Lead- and Infant Health Team Lead at CDC. She completed her MD and MPH at the University of Minnesota and is boarded in Obstetrics Gynecology and Preventative Medicine. As CDC Zika response she serves as part of the Pregnancy and Birth Defects Task Force. Our second presenter is Dr. John T Brooks. Dr. Brooks is a Senior Medical Advisor at CDC in the Division of HIV/AIDS prevention. Dr. Brooks completed his MD at Harvard Medical School and is an expert in transmission of sexually transmitted infections. Today’s third presenter is Dr. Jefferson M. Jones. Dr. Jones is an EIS officer at CDC. He completed his MD and MPH at Northwestern University. In CDC's Zika response he works as a Pediatrician as part of the Pregnancy and Birth Defects Task Force. At this time please welcome Dr. Olson.

Dr. Christine K. Olson: 
Thank you Will. During this outbreak we have seen rapidly evolving information about Zika virus infection, it’s modes of transmission and its effects on pregnancy and birth outcomes. CDC has written an updated clinical guidance and developed tools and information for clinicians and the general public. In addition, CDC has created a national registry to collect information about Zika affected pregnancies and subsequent birth and infant outcomes.

During this call we'll cover the following areas: a brief overview of Zika virus, updated interim guidance for prevention of sexual transmission of Zika virus, updated interim guidance for healthcare providers caring for women of reproductive age with possible Zika virus exposure, preventing transmission of Zika virus in labor and delivery settings through implement- implementation of standard precautions, interpretation of the pediatric testing guidance and the U.S. Zika Pregnancy Registry.

Zika virus disease is spread to people primarily through the bite of an infected Aedes species mosquito including Aedes Egyptis and Albopictus. These mosquitoes are aggressive daytime biters but they also bite at night. Data from previous outbreaks suggest most infections are mild and many are asymptomatic. Symptoms last for several days to a week and include fever, maculopapular rash, arthralgia, and conjunctivitis. Myalgia and headache may also be present. Severe disease requiring hospitalization is uncommon.

Other documented modes of Zika virus transmission include intrauterine and perinatal transmission, sexual transmission, and laboratory exposures. Additionally there have been reports of potential Zika virus transmission through blood transfusion. And this mode of transmission is being investigated. There's also a theoretical concern of transmission through organ or tissue transplantation. And Zika virus RNA has been detected in breast milk but has not been documented to cause infection in a nursing infant. No instances of Zika virus transmission during fertility treatment have been documented. But transmission through donated gametes or embryos is theoretically possible given that Zika virus can be present in semen and sexual transmission has occurred. Sexual transmission of Zika virus will be discussed later in the presentation.

As of today there are 33 countries or territories in the Americas and 41 countries worldwide currently reporting active Zika virus transmission. Updates on areas with active Zika virus transmission are available online.

Local vectorborne transmission of Zika virus has not been reported in the 50 U.S. states and DC but local transmission has been reported in U.S. territories. With the current outbreak in the Americas, the number of cases of Zika virus infection in U.S. travelers will likely increase. Imported cases may result in virus introduction to states and DC and local vectorborne transition might occur in some areas of U.S.

On April 1st, CDC brought together state, tribal, local, territorial and national stakeholders in Atlanta to discuss Zika preparedness and response activities. Through active investigation we are rapidly learning more information about Zika virus and pregnancy. Limited information demonstrates no evidence of increased susceptibility to Zika virus in pregnant women. Zika virus infection can occur in any trimester but the incidence of Zika virus infection in pregnant women is not known. There is no evidence that pregnant women have more severe disease compared with non-pregnant people.

An initial association between Zika and microcephaly was recognized in Brazil in May 2015 when an increased number of infants with microcephaly were reported following the onset of a Zika virus outbreak. Identified adverse pregnancy and birth outcomes including pregnancy loss, microcephaly, and fetal brain abnormalities and eye abnormalities. What is unknown is the level of risk that these adverse outcomes associated with Zika virus infection during pregnancy or around the time of conception.

We recognize that in the face of limited information it is challenging for healthcare providers to counsel women about the risks of Zika virus in pregnancy. For this reason CDC has proactively released and continually updates guidance as data emerges. Two recent studies provide some insight into the range of detected fetal abnormalities observed thus far. In Brazil among 42 women with laboratory confirmed Zika virus infection, 29% had abnormal findings on prenatal ultrasounds including two who had intrauterine fetal deaths. Other findings included abnormalities in blood flow, growth and amniotic fluid volume. Among the abnormalities detected, 17% had structural brain abnormalities including microcephaly, intracranial calcifications, ventriculomegaly and brain atrophy. Many of these pregnancies were still ongoing at the time of publication, however in one case prenatal ultrasound findings correlated with findings at birth and the infant had severe microcephaly, cerebral atrophy, and macular lesions.

In two of the pregnancies with prenatal diagnoses with microcephaly and intrauterine growth restriction the infants were small for gestational age at birth. In a second study a retrospective analysis of data from the 2013 to 2014 Zika virus outbreak in French Polynesia, prenatal Zika virus infection was associated with eight cases of microcephaly. Mathematical modeling estimated that infection with Zika virus during the first trimester of pregnancy resulted in a risk of microcephaly of approximately 1%.

In a recent report from the United States, a woman who had traveled during her first trimester of pregnancy to areas with active Zika transmission reported symptoms consistent with Zika virus disease in her 12th week of gestation. Initial prenatal ultrasounds were reported to be normal and microcephaly was not identified. However a decrease in fetal head circumference from the 47th to the 24th percentile was noted between 16 and 20 weeks gestation.

A fetal ultrasound at 19 weeks demon-demonstrated significant intracranial abnormalities including cerebral atrophy, ventriculomegaly, possible intraventricular hemorrhage and possible a genesis of the corpus callosum. Subsequent to these ultrasound findings a fetal MRI was performed at 20 weeks and demonstrated brain abnormalities consistent with the ultrasound findings. A postmortem evaluation following elective termination demonstrated cerebral cortical thinning. In addition the brain and other tissues contained high levels of Zika virus RNA and virus was cultured for brain tissue. I’d like to now turn the presentation over to Dr. John Brooks to discuss updates to the guidance of sexual transmission of Zika virus.

Dr. John T. Brooks: 
Thank you very much Christine and welcome everyone to the call this afternoon, or this morning depending on where you’re located. I'm going to present a brief update to the published guidelines. This update appears April 1st, 2016 is regard to interim guidelines for prevention of sexual transmission of Zika virus in the United States.

The initial guidance also an interim excuse me, guideline, also an interim guideline first appeared in the MMWR on February the fifth two thousand and sixteen. Since then CDC has continued to monitor, evaluate - and evaluate all available evidence in order to update recommendations as new information becomes available which has resulted in the update that we published April 1st.

CDC’s updated guidelines have been informed by and continue to be informed by our close collaboration with clinicians, professional organizations state and local health departments and many other stakeholders like those of you on the phone. There aren't a lar-large number of changes to the guidance. The main changes are clarification of the minimum time period that couples who are currently not pregnant should wait if they intend to have congenial sex. All other recommendations remain the same.

So let’s talk just a little bit about what we know about Zika virus and sexual transmission. We know that Zika virus can be sexually transmitted by a man to his sex partners, and that includes both male sex partners and female sex partners. But our concern, with regard to sexual transmission, is really around transmission to a woman during her pregnancy. All reported cases of sexual transmission to date have involved sex without a condom with a man who had or later developed symptoms.

Zika virus can be transmitted when the man has symptoms as well as days before symptoms start and days after symptoms end. Sexual transmission of many infections, including those caused by other viruses, is reduced by the consistent and correct use of latex condoms. There also are some things that we don’t know. We don’t know whether infected men who never develop symptoms can transmit Zika virus to their sex partners. We also don’t know how long Zika virus persists in semen.

We know from two case reports that infectious virus that is culturable virus can be found in semen at least 14 days after symptoms of infection began. And we know from one other case report that virus particles have been detected in the semen in a man 62 days after symptoms of infection began. However whether women can transmit Zika virus to their sex partners is unknown. And whether Zika virus can be transmitted from oral sex is also unknown. It is known that it's in semen but we don’t know if it’s in saliva or vaginal fluid for instance.

So what are the changes in our guidance? For pregnant women there is no change in the existing guidance. We still recommend that couples in which the woman is pregnant use condoms consistently and correctly or choose to abstain from sex for the duration of the pregnancy. A pregnant woman should still ensure that her healthcare provider's aware of her mail sexual partner’s potential exposure or if he has been ill. And this kind of discussion usually requires sharing information around the potential exposure of a male sexual partner to the mosquito such as the duration and extent of exposure, the male's use of anti-mosquito measures such as insect repellent.

Providers can consult our guidelines for evaluation and testing of pregnant women. The real change comes here when we're talking about other couples who are not currently pregnant. So, if a man has confirmed Zika virus infection or clinical illness consistent with Zika virus disease we recommend that that couples should use condoms or abstain from sex for at least six months after illness onset.

We consider this higher risk and we recommend six months because this is three times the longest period that Zika virus RNA has been detected in semen after system onset. Actually it’s greater than three times. We err on the side of caution here.

Now, if a man has traveled to an area with Zika - with active Zika virus transmission but did not develop symptoms, we recommend that the couple should consider using condoms or abstaining from sex for at least eight weeks after departure from the area. And this is three times the longest period that infectious Zika has been detected in the semen of men who were ill. So it's three times the longest time frame in which you would expect symptoms potentially to develop as well.

The more difficult decision if you’ll go back one slide please, the more difficult considerations is for couples who reside in areas of active Zika virus transmission and this really becomes a very nuanced discussion between the couple and their healthcare provider and between themselves. But we recommend that these couples might consider using condoms or abstaining from sex while active transmission persists in that area.

A little bit about testing with regards to determining whether risk of sexual transmission is possible. And we do not recommend that any testing be conducted to determine whether there is risk of sexual transmission. And the reason for these are really twofold. The first is that the test to detect Zika virus in semen, testing for that purpose is not widely available but of course that could change. And really the thing we're more concerned about is the second point here which is that we have very limited understanding of how to interpret results of semen testing. We really don’t know much about how frequently men develop seminal shedding if they've been infected with Zika, how long, so the incidence of that condition, how long it persists in the semen and what the pattern of shedding is. There's always the concern that shedding could be intermittent and you may collect a semen specim during a period when shedding is not occurring and have a falsely negative and falsely reassuring results.

Lastly I just want to say a few words about communicating with couples about sexual transmission and also to the community members. You know, talking about sex in general is hard for many people and sexual transmission of Zika can be very complicated. Of course anyone who's concerned about getting Zika virus from sex could choose to you con-use condoms or choose not to have sex. And as always to be effective, condoms must be used correctly from start to finish every time during sex.

Sex by our definition includes vaginal sex. That's penile to vaginal –vagina contact, anal sex or penile - penis and anal contact and oral sex or mouth to penis.

In some places there may be barriers to accessing and using condoms including their availability, their pricing and of course the partner’s ability to convince - one partner’s ability to convince the other to use condoms. Condoms (Couples) who do not desire pregnancy should additionally use the most effective contraceptive method that they can use correctly in consistency- consistently in addition to condoms. And I’ll just note that condoms also protect of course against a variety of other STDs.

And lastly folks religious beliefs can restrict a person’s ability to use condoms or other contraception and we just have to bear that in mind when communicating to the general public. So I think I’ll stop there and I'll turn it back over to Christine. Thank you.

Dr.Christine K. Olson:
Thank you. All right next I would like to discuss CDC’s most recent guidance which includes recommendations for women of reproductive age with possible Zika virus exposure. During the current Zika outbreak CDC has issued several guidance documents. Three of these guidance documents shown here have focused on pregnant women and women of reproductive age.

Although Zika is not new its potential effects on pregnancy have only recently been identified. We are learning more about Zika and what it means for pregnant women every day. CDC has been rapidly translating new findings into updated clinical guidance and we are committed to sharing what we know when we know it. As many of you know CDC has established the U.S. Zika Pregnancy Registry which has a will continue to provide critical information or inform updated guidance. Towards the end of this talk we'll provide more information about the registry.

We know it can be difficult to stay current with updated recommendations. CDC updates its recommendations when there are new data that can inform clinical and public health action. The purpose of our COCA calls is to provide an overview of the newest guidance and answer any related questions.

The most recent guidance was released on March 25th. The updated guidance includes new recommendations for women and couples who wish to conceive. This includes recommendations to individualize guidance based on the patient’s circumstances including presence or absence of symptoms consistent with Zika virus disease. There are also new recommendations for women and couples undergoing infertility treatment and for pregnant women living along the U.S., Mexico border. And lastly, the updated guidance includes minor modifications to the pregnancy testing algorithm.

Before we move into the specific recommendations it will be important to establish some clear definitions of terms used. Possible exposure includes travel to or residence in an area of active Zika virus transmission or sex, vaginal, anal, or oral without a condom with a man who traveled to or resided in an area of active transmission.

Zika virus infection means laboratory confirmation of Zika virus infection including in persons who are asymptomatic. And Zika virus disease means a person has at least one of the following signs or symptoms: acute onset of ra-fever, rash, arthralgia, or conjunctivitis and has laboratory confirmation of Zika virus infection.

People who have possible Zika virus exposure and display one or more signs or symptoms consistent with Zika virus disease but did not have testing performed should follow recommendations for peop-persons with Zika virus disease.

We'll now go through the recommendations for different situations and then review the algorithm in the most recently issued guidance document.

Women with possible exposure to Zika virus who do not reside in an area with active Zika virus transmission are the first group we'll discuss. Healthcare providers or HCPs should discuss signs and symptoms of Zika virus and the potential adverse outcomes associated with infection during pregnancy with their patients. If Zika virus disease is diagnosed a pregnant woman should wait at least - or I’m sorry, a woman should wait at least eight weeks after symptom onset to attempt conception. This recommendation takes into account the upper limit of the incubation period and the approximate trip-tripling of the longest known period of viremia active symptom onset.

No data are available regarding the risk for congenital infection among pregnant women with asymptomatic infection. If the woman has a possible exposure but no symptoms consistent with Zika virus disease, she should also wait at least eight weeks after the last date of exposure before attempting conception.

Healthcare providers counseling women and men interested in conceiving should provide information on ways their patients can prevent unintended pregnancies during the time after exposure or Zika virus disease that they are trying to avoid pregnancy. This includes discussion of the most effective contraceptive methods that can be used by the patient correctly and consistently. The patient should also be advised on a consistent and correct use of condoms for all vaginal and anal sex as well as fellatio to reduce the risk of sexual transmitted infections including Zika virus.

Let’s shift now to discussing men. Some recommendations differ between men and women based on the information we have available at this time about persistence of virus and semen.

As Dr. Brooks previously mentioned, there have now been several laboratory confirmed cases of sexually transmitted Zika virus disease from males to their partners. The duration and pattern of Zika virus persistence in semen is not fully characterized at this time and is under active investigation.

If a man with possible Zika virus exposure is diagnosed with Zika virus disease, he should wait at least six months after symptom onset before attempting to conceive. The applies to those men who are confirmed to have Zika virus disease through laboratory testing or those who have exposure and one or more signs or symptoms consistent with Zika but did not have testing performed.

The six month interval, again which is three times the longest period that Zika virus RNA has been detected in semen after symptom onset, allows enough of a time interval that the risk of sexual transmission is believed to be minimal. If a man has a possible exposure but no symptoms consistent with Zika virus disease developed, he should wait at least eight weeks after exposure to attempt conception with his partner.

Again during the time after exposure of Zika virus disease it is very important to discuss effective contraceptive methods and also advise patients on a consistent and correct use of condoms to resist - reduce the risk of sexual transmission. It's recognized that counseling women and men who reside in areas with active Zika virus transmission is challenging and that multiple factors need to be taken into consideration.

It is recommended that couples in these areas talk with their healthcare provider if they’re interested in conceiving. Counseling and discussion by the healthcare provider should include subjects that will aid in decision-making. These include the woman or couple's reproductive life plan. This may include age, reproductive history, medical history, fertility, and personal values and preferences. Counseling should also include an assessment of the risk of Zika virus exposure and a discussion about the prevention of both mosquito bites and sexual transmission of Zika virus.

Areas to review include their environment, whether the home environment has air conditioning, window screens, and is an area with a high density of mosquitoes. The same should be discussed about the work environment. The current level of Zika virus transmission at a local area should also be discussed.

Personal measures to prevent mosquito bites are important to discuss. This includes the use of protective clothing, long sleeve, pants, and permethrin treated clothing, use of EPA registered insect repellents as directed and emptying or removing standing water in containers.

Personal measures to prevent sexual transmission of Zika virus should be emphasized. This includes the patient’s willingness to use condoms or to abstain from sex for the duration of a pregnancy. It is important to counsel these patients about signs and symptoms of Zika virus disease as well as the possible adverse consequences of Zika virus infection during pregnancy and the need to wait until the risk of for viremia or viral shedding in semen is minimal to attempt conception. Risks and benefits of pregnancy at the current time should be discussed with the couple.

CDC has created a tool to aid healthcare providers in counseling women and men who were interested in conceiving and live in areas of active Zika virus transmission. This guide is available at the Web site you see on the screen and includes recommendations from the updated guidance, key questions to ask patients, and sample scripts to help facilitate discussion.

After discussion if couples decide to attempt a conception, healthcare provider should discuss the following: recommendations to use environmental protection agency registered insect repellents and the insect repellents are safe to use both while trying to conceive and during pregnancy. Use of insect repellents according to the instructions including reapplication as directed should also be emphasized.

It’s important to discuss with patients interested in conceiving the recommendations to wait to attempt conception if one or both members of the couple have Zika virus disease. Is recommended that women who have Zika virus disease wait at least eight weeks after onset of symptoms before attempting to conceive and that men who have Zika virus disease wait for at least six months to- be before attempting conception. Healthcare providers should advise couples to wait to conceive until the risk for viremia or viral shedding in semen is minimal. And this will involve discussion and judgment particularly in areas of active transmission. And importantly male partners should correctly and consistently use condoms or abstain from sex for the entire duration of the pregnancy once pregnancy is achieved,as this is the best way to avoid even a minimal risk for sexual transmission and the potential serious adverse fetal effects of Zika virus infection during pregnancy.

If couples decide to wait to conceive healthcare providers should ensure they discuss the best strategies for their patients to prevent an unintended pregnancy including use of the most effective contraceptive methods and the role of the use of condoms in reducing the risk for sexually transmitted infections including Zika. Next we’ll talk about circumstances that require special consideration, women undergoing infertility treatment and pregnant women living along the U.S.-Mexico border.

There have been no documented cases of Zika virus transmission during infertility treatment, though, from what we know transmission via donated gametes or embryos is theoretically possible. Zika virus is unlikely to be destroyed by cryopreservation so if present may persist. Treatment for couples who are sexually intimate and use their own gametes and embryos should follow the timing recommendations for those couples who are attempting conception. Based on patient circumstances care may need to be individualized.

The FDA has developed guidance for donated tissues in the context of a Zika virus outbreak. Living donors are ineligible for anonymous donation if they have at least one of the following: a medical diagnosis of Zika virus infection in the past six months, they resided in or traveled to an area with active Zika virus transmissions within the past six months ,or within the past six months they had sex with a male partner who during the six months before the sexual contact was diagnosed with, or experienced an illness consistent with Zika virus disease or had traveled to an area of active Zika virus transmission. Areas of active Zika virus transmission in parts of Mexico that do not directly border the United States have been reported. Healthcare providers who care for pregnant women who reside along the U.S.-Mexico border should assess their patients' travel histories including frequency of cross-border travel and destinations. They should also inquire about the travel of their patients’ sexual partners as that exposure could also pose a risk.

There are currently no reports of active Zika virus transmission along the U.S.-Mexico border. However, if active transmission occurs local health officials should determine when to implement testing of asymptomatic pregnant women based on information about local levels of Zika virus transmission and current laboratory capacity. Next we’ll talk about the current testing recommendations.

CDC recommends the following Zika virus diagnostic testing when testing is indicated. Reverse transcription polymerase chain reaction or RTPCR detects viral RNA and serum and should be collected within seven days after symptom onset. Because viremia decreases over time, a negative RTPCR result from serum collected five to seven days after onset of symptoms does not exclude Zika virus infection therefore serologic testing for Zika virus IGM should be performed if the specimen's collected four or more days after illness onset. Healthcare providers should work with their state, local, or territorial health departments for facilitation and interpretation of testing.

Serologic testing for Zika virus can be offered to asymptomatic pregnant women with possible Zika virus exposure including travel to or residence in an area with ongoing Zika virus transmission. A negative IGM result within two to 12 weeks after exposure could suggest that a reckent-recent infection did not occur and could obviate the need for serial ultrasound. However negative serologic result cannot definitively rule out Zika virus infection.

Information about the performance of testing in asymptomatic persons is limited. We'll now talk about the testing algorithm for pregnant travelers that has been revised in the updated guidance.

CDC has updated recommendations about whom to test. This is the current guidance for testing of pregnant women with possible Zika virus exposure who do not reside in an area with active Zika virus transmission. These women should be evaluated by their healthcare providers for possible Zika virus infection. This includes inquiring about exposure through travel or sexual activity, symptoms consistent with Zika virus infection, and physical examination. If the pregnant patient has been ill with one or more signs or symptoms consistent with Zika virus disease within two weeks of travel to an affected area, serum testing should be performed.

Healthcare providers should work with their state, local or territorial health departments to order and interpret testing. Testing can be offered if the woman does not report clinical illness consistent with Zika virus disease but did have possible exposure including history of travel to an area with active Zika virus transmission or sex without a condom with a male partner who had symptoms consistent with Zika virus disease. Testing is not currently recommended for pregnant women with possible sexual exposure to Zika virus if both partners are asymptomatic.

As more has been learned about the fetal abnormalities associated with Zika virus, language around the findings on fetal ultrasound that may indicate congenital Zika virus infection has been broadened. In addition to microcephaly and intracranial calcifications, abnormally formed or absent brain structures, microphthalmia, cataracts, and other eye abnormalities have been detected. The algorithm was therefore modified to reflect this with changes shown here in red text.

In addition, amniocentesis was removed from the algorithm. Amniocentesis may be used in the evaluation of a patient, but clinical decisions about the use of amniocentesis will need to be individualized according to patient circumstances. CDC has also updated recommendations for pregnant women residing in an area with active Zika virus transmission. The pregnant woman should be evaluated and if she has been ill with one or more signs or symptoms of Zika virus disease testing should be performed at that time.

If the woman does not report signs or symptoms of Zika virus disease then serum testing for Zika virus can be offered during the pregnancy. IGM can be offered upon the initiation of prenatal care. And if that test is negative repeat testing with IGM can be considered in the mid-second trimester because of the ongoing risks of Zika virus exposure and infection during pregnancy in an area with active transmission.

As with women residing in areas without active Zika virus transmission if clinical illness consistent with Zika virus disease develops at any point in pregnancy repeat Zika virus testing is warranted. Testing is not recommended in the setting of possible sexual exposure if both partners are asymptomatic.

As with the algorithm for pregnant women with possible Zika virus exposure but not residing in an area of active transmission similar changes were made. These included removal of the amniocentesis language as well as broadening the language used for finding some fetal ultrasounds that may indicate congenital infection with Zika virus.

Next, we’ll switch gears and discuss guidance that was issued about infection control in the labor and delivery setting through use of standard precautions in the context of Zika virus. Zika virus has been detected in multiple body fluids including blood, amniotic fluid, urine, saliva and semen as previously mentioned. At this time there have been no reports of transmission of Zika virus from infected patients to healthcare personnel or other patients.

Labor and delivery settings have the potential for exposure to large volumes of body fluids due to the nature of the care provided. Healthcare personnel or HCPs working in these settings must adhere to standard precautions as they could - as they should in all healthcare settings.

CDC recommends standard precautions in all healthcare settings to protect both healthcare personnel and patients from infection with Zika virus, as well as from other blood-borne pathogens for example HIV and Hepatitis C virus. Standard precautions that are basic measures all healthcare personnel should take to prevent infection and apply to all patient care settings.

The goals of standard precautions include: preventing contact between a patient’s body fluids and healthcare personnel’s mucous membranes including eyes, skin, and clothing, preventing healthcare personnel from transmitting potentially infectious material from one patient to another, and avoiding unnecessary exposure to contaminated sharp implements.

Standard precautions include hand hygiene, use of Personal Protective Equipment or PPE, safe injection practices, and safe handling of potentially contaminated equipment or surfaces in the patient’s environment.

Healthcare personnel must assess their personal risk for exposure to blood and body fluids based on the type of patient contact and the nature of the clinical procedure activity and select the appropriate PPE based on that information. PPE includes gloves with double gloving having the potential to reduce percutaneous injuries when handling sharps, impermeable gowns, masks, eye protection either goggles or face shields, and knee-high impermeable shoe covers.

Examples of procedures that require increasing levels of PPE in the labor and delivery setting include vaginal examinations particularly during amniotomy or rupturing membranes when exposure to fluids will be expected, performing a vaginal delivery or manual removal of a plus-of a placenta when exposure to larger volumes of fluids would be routine and procedures in an operating room setting where clothing, skin and mucous membrane and protection should be maintained. Healthcare personnel should consider the anticipated exposure to blood and body fluids and the opportunities for splashes of these fluids. Appropriate PPEs should be worn to protect mucous membranes including the eyes accordingly.

In addition all healthcare personnel on a team that are involved in the same procedures should use the same level of PPE. In addition to use of PPE by healthcare personnel, placement of disposable absorbent material on the floor around the procedure and delivery area to absorb fluid can reduce the risk for splash exposure to body fluids. Infection control supplies should be available and accessible in all patient care areas where they will be needed. Standard cleaning and disinfection procedures for environmental services using EPA registered hospital disinfectants should be followed.

It is important for all occupational exposures to be- be reported to a facility’s occupational health clinic so that appropriate assessment of healthcare personnel can occur and any system- systemic safety risk can be promptly addressed. Ongoing education and training of all healthcare personnel about standard precautions and the use of appropriate PPE help ensure that infection control policies and procedures are understood and followed.

Any barriers to -to the routine use of standard precautions and appropriate PPE should be addressed immediately when ideniside-identified. Facility nursing and obstetric leadership is critical for instituting infection prevention policies and promoting routine use of and adherence to standard precautions.

Next I’ll turn the presentation over to Dr. Jefferson Jones to address the interpretation of the pediatric testing guidance for Zika virus and to discuss the U.S. Zika Pregnancy Registry.

Dr. Jefferson M. Jones:
This is the algorithm for the evaluation and testing of infants. The guidance represented by this algorithm is still current. However it's important to highlight some areas that are influenced by the updated guidance for women of reproductive age with possible Zika virus exposure. These updated guidelines apply to infants particularly in two important ways.

Here in the circle text in addition to travel to a residence in an area of active Zika virus transmission, mothers of infants can be exposed to Zika virus through sex without a condom as previously described. And in addition to microcephaly and intracranial calcifications as listed here, abnormalities consistent with Zika virus disease also include brain and eye abnormalities.

We'll end the presentation by discussing the new U.S. Zika Pregnancy Registry. As we have discussed today, Zika virus infection during pregnancy has been linked to adverse outcomes. Despite these observations very little is known about the risks of Zika virus infection during pregnancy. CDC has established the U.S. Zika Pregnancy Registry to monitor pregnancy and infant outcomes to learn more about the timing, absolute risk, and spectrum of outcomes associated with Zika virus infection during pregnancy to help inform clinical guidance and direct public health action.

Registry is a supplemental surveillance effort coordinated by CDC and is dependent on the voluntary collaborations of clinicians and state tribal, local, and territorial health departments. The registry will include pregnant women that have laboratory evidence of Zika virus infection and exposed infants born to these women. If infants with previously unrecognized congenital Zika virus infection are identified their mothers will be included in the registry retroactively. It is worth noting that the Zika Pregnancy Registry inclusion criteria are broader than the current counsel of states and territorial epidemiologist's interim case definition. The registry includes pregnant women with positive or inconclusive Zika test results regardless of whether symptoms are present.

It also includes all children born to these women, not only those with identified congenital infection. You can support the registry by spreading the word about its importance and working with your health department to report cases and collect clinical and follow-up information.

If you’d like more information about the U.S. Zika Pregnancy Registry please feel free to call the Zika Pregnancy Hotline or email us at zikapregnancy@cdc.gov. All of the materials described in this presentation can be found at the link listed on this slide. All of this work - all of this is the work of many people. Many thanks to all of our collaborators and thank you all for listening today.

Will Koehne:       
Thank you presenters for providing our COCA audience with such a wealth of information. We will now open up the lines for our question and answer session. Questions are limited to Zika virus related topics. For those that have media questions please contact CDC Media Relations at 404-639-3286 or send an email to media@cdc.gov. If you are a patient please refer your questions to your healthcare provider. When asking questions please state your organization. And also remember that you can submit questions through the Webinar system as well.

Coordinator:       
Thank you. We will now begin the question and answer session. If you’d like to ask a question from the phones please press Star 1, make sure your phone is unmuted and record your name. To withdraw that request you may press Star 2. Once again for a question or a comment from the phones press Star 1 at this time. I'll standby for questions or comments. One moment.

Will Koehne:       
Thank you Carolyn. While we're waiting for those, we have a couple of questions on the Webinar system. One of the ones here is Mary McIntyre. She asks if a pregnant woman has exposure history and had symptoms consistent with Zika virus exposure but is now more than three months post return or post symptoms onset since - should serology testing still be done? How far out can testing be done on pregnant women after returning to the United States?

Dr. Christine K. Olson:
Alright. Thank you. This is Christine Olson. At this time we know that the two to 12 weeks following exposure or infection is the best time to try to test for IGM in serum. We are looking carefully at other lab results as more information comes in and as we mentioned during this talk we are learning things on almost a daily basis about Zika virus.

If it’s - if you have a patient in that situation the best advice would be to contact the local health department at that time and discuss testing with them as they should be updated on the most recent guidelines for laboratory testing. And we're just conscious that there's updated guidelines, there are- is updated guid-guidance coming out on a fairly regular basis and hesitate to provide an answer that may at some point become incorrect as we learn more information.

Will Koehne:       
Thank you. Operator are there any other questions on the line yet?

Coordinator:       
Yes. We do have some questions from the phones. Our first question or comment is from Dr. Rossi Hassad. And please state your organization.

Dr. Rossi Hassad:
Hi. I’m Rossi Hassad, Epidemiologist Mercy College New York. Thanks for your presentation. I recognize that because of the severity of the associated fetal abnormality the much of the emphasis from CDC seems to be on conception and pregnancy and hence on sexual transmission from male to female. However almost everything we are learning about Zika is new knowledge. Therefore given that it is quite, if not highly plausible that there could be transmission from female to male would it not be wise to make that a stronger message in our health education and awareness campaign recognizing that every infected person, male or female, is a potential source or if not a source of the virus from which it can spread? Thank you.

Dr. John T. Brooks: 
Dr. Hassad this is John Brooks and thank you very much for that question. We - yes, that’s a very good question to ask. You know, we're an agency that’s data driven and we make recommendations based on the first - on the based available - best available scientific evidence. Now unfortunately at this time we don’t have any data on the - on whether vaginal secretions or saliva for that matter can contain infectious Zika virus in it.

I recognize the biological plausibility. And so we’ve, you know, we've consider this to some-some extent. As you - and I'll come back to this in just a moment. As you pointed out however we are really most concerned about pregnancy.

The consequences for non-pregnant adults are not minor especially if you're the person who gets Guillain-Barre for instance if that indeed turns out to be something associated or one of the other complications. So we worry about that in non-pregnant adults. Many of the recommendations we make for preventing any sexual transmitted disease would apply in this case to Zika as well that is to say those recommendations for preventing other sexually transmitted diseases should be adequate for preventing Zika transmission.

The difficulty is with a couple where, you know, there's no concern about sexually-transmitted diseases. That couple could certainly employ other barrier methods to prevent transmission. But we just don’t have any evidence at the present time that penile or oral exposure to vaginal fluids or exposure to saliva can transmit the virus.

Having said that I would welcome, we would very much welcome any data or case reports people can pull together or send to us if you encounter a potential case like that. And I believe we have studies ongoing that are collecting specimens so that we can better understand exactly what’s in these fluids.

Dr. Rossi Hassad:     
Thank you.

Coordinator:       
Thank you. Our next question or comment comes from Bill Pierce and please state your organization.

Bill Pierce:           
Hello. My name is Bill Pierce. I’m from Lourdes Health System in New Jersey. My question is related to the patients that are to be tested and more appropriately the ones that are being actively screened. I guess I have two questions. One is, is our State Department of Health making independent decisions on who gets tested or not or are they receiving information from the CDC so that we're all on the same page regardless of state?

And the second one is is it prudent for us to do screening on every patient that comes in to see if they’ve been to a Zika outbreak area or is it better to focus just on the pregnant patient?

Dr. Christine K. Olson:
Okay. Thank you.

Dr. John T. Brooks: 
I can help with that.

Dr. Christine K. Olson:
Okay thank you for your question. I think Dr. Brooks will jump in here in a moment. But in terms of the first question you asked about the State Department of Health we work very, very closely with state and local territorial tribal health departments on guidance that we issue. And, you know, they also send us information that’s very helpful in informing guidance.

                             
So we consider ourselves a, you know, a network basically and work together. They do make decisions at the local and state level that apply directly to their populations and in the application of that guidance. But we have a very, very strong collaborative relationship with them. And then I’m sorry your second question was about the screening of every patient and I also want to…

Dr. John T. Brooks: 
Mhmm

Dr. Christine K. Olson:
…state that…

Dr. John T. Brooks: 
Sure. So for instance why aren't we recommending that everybody who is either returning or maybe hasn’t actually reported bidding to-been - having been to an area of active Zika transmission be screened for the presence of the virus? A couple of reasons.

The first is that the testing is actually in it is really relatively young and is being developed. And we don’t have good confirmatory testing right now for a person who has an IGM positive test. So that for instance if you were thinking of a model of HIV testing where we recommend using a very sensitive test to identify people who may have been infected and then using a more specific test to identify those people who’ve actually got the infection we don’t have the privilege of that right now.

You know, pretest - the pretest probability is really where we want to focus attention in testing. We want to test those people where the result is first most likely to have meaningful clinical information to provide and where the person is in the pool of people who may actually have been those exposed to the virus. I would anticipate that this whole realm of testing for Zika will expand as the outbreak continues. But at the present time we really want to focus those efforts on those persons where the pretest probability is the most - is the greatest and where the result will have the most clinical meeting.

Bill Pierce:           
Perhaps I didn’t ask my question clearly enough.

Dr. John T. Brooks: 
Sure.

Bill Pierce:           
Not on the testing of the patient but the screening. I-I work- worked for a-for a hospital. So…

Dr. John T. Brooks: 
Sure.

Bill Pierce:           
…should we be screening 100% of the patients that come in for Zik- potential Zika exposure…

Dr. John T. Brooks: 
No. No no no.

Bill Pierce:           
…or only focus on the pregnant patients?

Dr. John T. Brooks: 
Right. We – don’t the- the testing for Zika should be directed by exposure history or clinical presentation. This is not designed to be a screening test. So you should be testing people who either have the appropriate travel history and illness that's in - so a ill man or an ill woman who is not pregnant that the persons have the right cluster of symptoms or for pregnant women it varies a little bit depending on whether you’ve been to the jurisdiction or not and whether you may have been exposed to a man who had traveled to an area or lives in an area who has been symptomatic. So not designed as a screening test.

Bill Pierce:           
Right. However we and in the hospital should be screening 100% of the people that come to our doors?

Dr. Christine K. Olson:
You mean - I’m sorry you mean you’re-you’re asking about taking a travel history and-and trying to ascertain potential exposures is that-is that correct?

Bill Pierce:           
Correct, specifically for Zika.

Dr. John T. Brooks: 
I mean coup- when coupled with collecting a travel history from patients I think that is a- a reas- you know, a reasonable approach. But that would have to be individualized based on both the - what the lab storage capacity is at your institution or the state health department and what’s really reasonable for the environment that you’re working in.

Yea and it-it’s been pointed out to me that we have the same experience. Right, we have the same experience with the Ebola virus where there's the same kind of question was coming up. You know, should we be routinely screening people for Ebola at that time? You know - no we wouldn't recommend routine screening. What we do is we recommend that everybody-everbody has a good travel history collected and then that can be the starting point to go further down the algorithm to determine if that is a person for whom testing may be indicated.

Bill Pierce:           
Thank you.

Dr. John T. Brooks: 
Sure.

Coordinator:       
Thank you. Our next question or comment comes from Aaron Glatt and please state your organization.

Aaron Glen:        
Hi. My name is Aaron Glen. I’m at South Nassau Community Hospital. And my question is in regards to patients who are pregnant and their partner for whatever reason, religious or otherwise cannot use a condom during pregnancy. And the recommendation is officially to either abstain or not use a condom during pregnancy. And that’s just not possible.

Does it make sense to recommend IGM testing on the spouse who was in an-an affected area and if that is negative to reassure them that the likelihood of Zika is very low in that situation of transmission from the spouse to the infected woman to the-to the pregnant woman?

Dr. John T. Brooks: 
Sure. Yea thanks. This is John Brooks again. I appreciate that useful question. Unfortunately no. We don’t – we-we can’t recommend IGM testing to determine whether the male spouse let’s say in this circumstance may have had Zika. Every test has a potential false positive rate and it would be falsely reassuring in the event the man actually did have Zika virus and it wasn’t, you know, and he got a false-false result. And there isn’t at the current time a confirmatory test for us to go - and go forward from that to determine whether it was falsely positive, falsely negative or true positive or true negative.

Aaron Glatt:       
Are there any cases where a person has had an IGM test where it has been negative and –and it has been found that he has in fact either had virus present or has transmitted virus to a –a sexual partner?

Dr. John T. Brooks: 
Yes. I’m not aware of having transmitted sexually to a partner in that circumstance, but it certainly is theoretically possible that early in the course of infection you could have a yea, that early in the course of infection a-a person may have virus present but has not yet mounted the adequate IGM response for it to be detected on the test. It's often called a window period.

Aaron Glatt:       
Right.

Dr. John T. Brooks: 
It’s also quite possible that if a man has been infected with Zika that it may be persistent in his semen even after the IGM is no longer present in the serum. And this is an area of very active investigation to better characterize what the time patterns are of the IGM response in the incidence and persistence of semen.

Aaron Glatt:       
Again I-I don’t mean to be persistent but I’m being asked this question very frequently where the couple will not use a condom or they will-they will not abstain during the entire pregnancy. Why wouldn’t an IGM test be somewhat reassuring understood that it’s –it’s not perfect as opposed to having no test at all? And assuming that the test was even done three weeks after symptoms and then maybe six weeks after- three weeks after exposure and six weeks after exposure it would seem to me statistically speaking that that would be a very reassuring albeit not perfect solution to their worry and angst?

Dr. John T. Brooks: 
Yes. I fully, fully appreciate what you’re getting at. This is a very delicate and tough-tough situation. Unfortunately we don’t have enough data to know actually how statistically likely the circumstance is that a negative IGM test in a guy who's traveled is going to be informative. The most important thing to remember here is the serum IGM test is not informing us about what's going on in the semen. And we know in at least two case reports that gentlemen have had culturable Zika virus in their semen after their blood had cleared the virus in terms of PCR.

We – it-unfortunately we didn’t have – those-those are old reports. We don’t have the antibody result to go with them, but you could still end up in a situation with a falsely negative antibody test and the gentleman actually has virus in semen.

In a circumstance like the one you are describing, if the couple is unwilling and able for whatever the circumstances are, unable - not able to use condoms or abstain I would certainly make sure that if pregnancy occurs that person is pregnant that the health care- that the OB/GYN is well-informed of that and that they’re working up and following that pregnancy with ultrasound to make sure that there aren’t other problems going on.

Aaron Glatt:       
Thank you.

Will Koehne:       
We're going to take one quick question from the Webinar system. This is Lisa Samens question. After laboratory confirmed - after a laboratory confirmed infection what is known about subseq-subsequent immunity to repeated exposures to Zika virus?

Dr. John T. Brooks: 
To the best of our knowledge at the present time following infection is lifelong immunity. We have no evidence to the best of my knowledge that persons who've experienced diagnosed Zika infection have had recurrent infections.

Will Koehne:       
Thank you. Operator are there any other questions on the phone lines?

Coordinator:       
Yes we do have some more questions. Our neck question - next question or comment is from Stephanie Hillshire and please state your organization.

Stephanie Hillshire:  
Good afternoon. I’m from Texas Tech University Health Sciences Center in Lubbock, Texas. I’m a nurse and chief clinical analyst for our EHR here in Texas. With recent news coming out this morning internationally and specifically within the United States such as like the Washington Post what's the CDC stances on - and this might be related more to ques- to the two questions ago about –indult-adult involvement with them claiming that out of Brazil and neurology departments saying encephalomyelitis might be affiliated now with this in adult. Can we be expecting adults to be added to the screening and kind of like what they mentioned two questions ago? Thank you.

Dr. John T. Brooks: 
Well it’s again that’s –that’s a great question and we're vigilant for the possibility of complications outside of pregnancy that may be caused by this virus. You know, I think it was made - it's-it’s actually abundantly clear our responses. And as you all know on the ground, you know, we're learning every day more and more about what’s going on. So we are - we wouldn’t necessarily be surprised to learn the things we're not aware of yet that come to the fore in terms of adult complications such as meningoencephalitis or Gulliain-Barre Syndrome.

I think the risk is however at the present time very low but that’s being looked for and monitored. I don’t think it’s an indication therefore to necessarily screen all adults but as I might’ve, you know, I'll clarify again said before that testing really in that circumstance should be directed by the travel history and the clinical illness. And I could certainly imagine if you have a case of micro - sorry of meningoencephalitis or any other kind of demyelinating CNF disease that if a person isn't unable to communicate and you’re worried about trying to rule out what’s going on or you - or there may be the possibility of local or endemic spread in where –where you’re located such as in Texas perhaps certainly testing that person would be a –would be a wise and warranted thing from an infectious disease perspective.

Stephanie Hillshire:  
Thank you. And I assume like the MMWR would be given a some sort of heads-up if the algorithms were going to change a move that direction?

Dr. John T. Brooks: 
Absolutely. We worked very hard to get those out as promptly as possible when we are changing- when those kinds of things occur. I can say with great assurance that should this turnout - should something like that arise there'll be very rapid communication from our agency.

Stephanie Hillshire:  
Excellent. Thank you.

Dr. John T. Brooks: 
Yea thank you.

Coordinator:       
Our next question or comment comes from Jeffrey Silvers. And please state your organization.

Jeffrey Silvers:    
Yea hi. This is Jeffrey Silvers. I’m a medical director of quality for infection control for all of Sutter Health of Northern California. And my question actually is simil-similar to a previous one.

So in emerging infectious diseases in February of last year there was a report by Mousseau’s for the outbreak in Tahiti and French Polynesia were they actually had the-the one man who developed symptomatic Zika that lasted three or four days. And then eight weeks later he developed another classic illness and then two weeks after the - he got hematospermia. So is that not the first case or do you know of any additional cases suggesting that there might be either an-an ability to get the disease a second time or actually have a relapsing form of disease?

Dr. John T. Brooks: 
Great question. That is - now you see - that is a very tough article wasn’t it? Because basically so folks on the phone are aware this was a situation of a gentleman who developed a clinical illness that looked just like Zika. Two - eight weeks later had another illness just like Zika but we don’t have any testing from that first event or really the second event to know which one of those was the Zika like illness. We don’t know think that that’s - that is likely that that was a case of a person having either recrudescence. So they had Zika it kind of went away but then it flared up again. To the best of our knowledge it was an immunocompetent host for instance or that he had –had the infection once and then got it a second time. In that case the-the samples of semen that were collected would therefore be given the two illnesses either 14 days or potentially as far as around 70 days from the time of initial illness.

The guy was pretty sick. He also had hermatospermia or blood in his semen which has only been reported in one other case. So he-there was a - it was somewhat exceptional. This is one of the reasons why we're working very hard to engage folks who are returning to the United States, men who are returning to the United States and diagnosed with Zika to engage them through their state health department in a protocol we have here to test semen and are conducting semen studies overseas as well to get a much better sense of what’s going on.

Jeffrey Silvers:    
Okay so that really does even as you say you-you’re not convinced that really still speaks to the possibility of either relapsing or reinfection. And when you say there is no evidence there’s this is perhaps the only case that you know of this reported?

Dr. John T. Brooks: 
It's well, you know, the difficulty here is there were other infections going on at the same time. He could have been exposed to chikungunya. He could have been exposed to dengue which both of which clinically could have possibly mimicked Zika virus. You know, there is enough overlap between the symptomatology of these diseases that it would have been hard to clinically distinguish if it was actually Zika two times.

Jeffrey Silvers:    
Sure.

Dr. John T. Brooks: 
There certainly are –there certainly are case reports of people being infected with two of these viruses, if not simultaneously, within short order of each other.

Jeffrey Silvers:    
Thank you very much.

Dr. John T. Brooks: 
Yea thanks.

Will Koehne:       
Operator we have time for one more question. Are there any…

Coordinator:
Okay. Thank…
Will Koehne:    
…more on the line?

Coordinator:       
Yes there are. And our final question comes from Jody Minnick. And please state your organization.

Jody Minnick:     
I’m from the Montgomery County Health Department and we have a question about when-when results come that say high brack-background for Zika what are the implications of that and how do we counsel providers in what they should do with that information?

Dr. John T. Brooks: 
You know, I’ll -I’ll confess it- I’m not sure what the format of the reporting form is that you’re getting from the state or the- if there's another way of doing the testing. But I would actually recommend first contacting the state with that question. Is this Montgomery County, Maryland?

Jody Minnick:     
Yes.

Dr. John T. Brooks: 
Thank you so much for taking care of my family. And you know-I know you have a lot of NIHers there as well. So this is one the-the state lab there and David Blythe is the State Epidemiologist. They're are excellent people and I’m sure they could answer - help you answer that question.

I’ve not heard the term used but there was a high background of Zika before. But I would-I would refer you back to them to interpret it. And if you continue to have questions you can always call us here at CDC. And do we have that number handy what the number is to call in case you have questions in regards to either clinical questions or interpretation of laboratory results? It’s area code 770-488-7100 that’s 770-488-7100. That’s our Clinical Inquiries line.

Jody Minnick:     
Thank you.

Dr. John T. Brooks: 
And you may – yea- and when you call this number let me just caution-when you call this number you need to ask and say I want to speak to someone about a clinical scenario or about a laboratory result. Thanks.

Will Koehne:       
Thank you. On behalf of COCA I would like to thank everyone for joining us today with a special thank you to our presenters Doctors Olson, Brooks, and Jones. We invite you to communicate with our presenters after the Webinar. If you have additional questions for today’s presenters please email us at coca@cdc.gov. Put April 12th COCA call in the subject line of your email and we will ensure that your question is forwarded to the present-presenters for a response. Again that email address is coca@cdc.gov.

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Coordinator:       
That concludes today’s conference call. Thank you for your participation. You may disconnect at this time.