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Disaster response and global health
One step forward, two back…
No adult alive today will live to see global gender parity. The 2020 World Economic Forum Global Gender Gap Report, published December 2019, assessed four dimensions of gender inequality – health, economic opportunities, educational advancement, and political empowerment.
The report stated that despite some advances, overall global gender parity would not be reached for 99 years. The gender gap is not solely a developing nation’s problem. The US standing as the 51st in gender parity fell to 53rd during the previous 2-year period. And these numbers were before Covid COVID-19.
Disasters, including pandemics, negatively affect female subjects disproportionately. Covid COVID-19 has unmasked and exacerbated both gender and minority disparity. Global health care workers (HCW) are overwhelmingly female, exposing them to a higher risk of contagion. This risk was exceptionally high among Black, Asian, and minority ethnic HCW (Nguyen et al. Lancet Public Health. 2020;5[9]:E475). The gender pay gap, where women are paid 80% of their male counterparts and women of color make 63%, has led to a greater financial burden among female HCW during Covid COVID-19. Women, including HCW, provide the majority of the unpaid work, i.e., childcare, elder care, and home care. 2020 saw an unprecedented loss of women in the workplace, including health care. Both clinical practice and research have been affected. The long- term effect on women HCW careers is unknown at present. Global gross domestic product growth loss due to this decline in the female workforce is estimated at 1 trillion USD over the next decade.
Disaster and gender parity are entwined. Covid COVID-19 has revealed the persistence of inequalities that nees to be considered in future disaster planning.
Mary Jane Reed, MD, FCCP
Steering Committee Ex-Officio
Interstitial and diffuse lung disease
Emergence and benefits of home monitoring and telemedicine for patients with ILD
Patients with interstitial lung disease (ILD) require regular monitoring with outpatient clinic visits and pulmonary function tests.
The emergence of COVID-19 forced an unprecedented transition to telemedicine and a new reliance on home monitoring. Home spirometry enables quick detection of rapidly progressive disease and is more sensitive than hospital-based spirometry in predicting prognosis (Russel, et al. Am J Respir Crit Care Med. 2016;194[8]:989). Patients with idiopathic pulmonary fibrosis randomized to a home monitoring program had improved psychological wellbeing and higher patient satisfaction with individually tailored treatment decisions (Moor, et al. Am J Respir Crit Care Med. 2020;202[3]:393). However, there are some inaccuracies in home monitoring. For instance, pulse oximetry is less reliable in African American patients receiving supplemental oxygen (Sjoding, et al. N Engl J Med. 2020;383:2477). It is critical to protect ILD patients from potential COVID-19 exposure given the high risk of serious complications. Telemedicine should be offered to all patients and may actually increase access to care in ILD patients, a population with disabling dyspnea and supplemental oxygen needs that requires specialist care unavailable in many geographic regions. African American patients, those older than 65, and patients with lower socioeconomic status are less willing to engage in videoconferencing (Fischer, et al. JAMA Netw Open. 2020;3[10]:e2022302). It is essential that telephone visits be offered to minimize disparities in access to care. Many telemedicine platforms enable caregivers and family members to attend visits from separate locations and provide a unique opportunity to address advance care planning. In-person visits should be arranged for patients with no access to internet or telephone or those with poor medical literacy or insufficient social support to conduct a productive remote visit. Telemedicine and home monitoring have proved invaluable during the COVID-19 pandemic and have the potential to continually increase access to and quality of care.
Rebecca Anna Gersten, MD
Steering Committee Member
Practice operations
Use of media platforms to eliminate the COVID-19 infodemic
We were shocked when we read a tweet in December 2020 from a health care worker stating, “My biggest concern is the lack of data and the quick development time. Feels like we are a bunch of guinea pigs” in reference to the new COVID-19 vaccine.
I reflected back on the last pandemic in 2009, H1N1, and remembered when the new vaccine developed in 174 days was first released to pregnant women and children after phase 3 trials. How did we get here? What do we do to fix it?
This misinformation is labeled as the “COVID-19 infodemic.” In the last year, we have seen the media, more specifically social platforms, quickly spread medical misinformation. In the book “Made to Stick: Why Some Ideas Survive and Some Die,” the authors described core elements that make an idea “sticky.” Use of those exact same sticky techniques can be used to circulate accurate information and to halt the spread of this infodemic. Although, numerous media companies, including Twitter, are making an effort to remove the false content from their platforms, their efforts require a lengthy process and are delayed. Therefore, it is crucial for the public health figures and community at large in partnership with various national organizations to establish a robust connection with the social platforms in a dynamic and timely fashion to help spread the verified information across social media, digital and traditional media outlets.
The UN has launched an initiate called “Verified.” This is a worldwide effort to help individuals spread reliable information regarding COVID-19 to their friends and families via social platforms as various media platforms and businesses have partnered with Verified. Also, we encourage our members to access the CHEST COVID-19 resource center and benefit from the various clinical and practice management tools along with validated patient information materials.
Roozera Khan, DO, FCCP
Steering Committee Member
Humayun Anjum, MD, FCCP
Chair
References
1. The Lancet Infectious Diseases-Editorial. The COVID-19 infodemic. Lancet Infect Dis. 2020;20(8):875.
2. Tangcharoensathien V, et al. Framework for managing the COVID-19 infodemic: methods and results of an online, crowdsourced WHO technical consultation. J Med Internet Res. 2020;22e19659.
3. Verified. https://shareverified.com/en/about. Accessed Feb 18, 2021.
Transplant
COVID-19 + lung transplant
The COVID-19 pandemic has created a dilemma for lung transplantation, with a new group of patients with refractory respiratory failure secondary to the viral illness. As transplant centers worldwide receive referrals for COVID-19 related respiratory failure, information regarding evaluation, listing, and posttransplant care continues to be published, but further research will be needed to care for this complex population.
The first lung transplant for COVID-19 in the United States occurred at Northwestern Hospital on June 5th, 2020,and was publicized for its innovativeness. Information from their three lung transplants completed thus far includes information regarding pathologic findings of the explanted lung tissue; pulmonary fibrosis was the dominant feature, suggesting COVID-19-induced acute respiratory distress syndrome with prolonged time supported by mechanical support may only be survivable with the use of lung transplant (Bharat, et al. Sci Transl Med. 2020;12(574):eabe4282).
Lung transplant in the setting of COVID-19 fibrosis increases surgical complexity as well, with case reports of dense adhesions and distortion of regular surgical planes (Bharat, et al. Sci. Transl. Med. 2020; Lang, et al. Lancet Respir Med. 2020;8:1057). Recognizing the difficulty with deciding to use transplantation after an infectious disease, The International Society for Heart and Lung Transplant (ISHLT) has created guidelines regarding indications for transplantation (ISHLT.org). Continued research will be necessary to identify those at the highest likelihood for success from transplantation, preparation for the increased complexity, and long-term outcomes. Further information is available in a CHEST webinar titled “Lung Transplantation in the Era of COVID-19” .
Clauden Louis, MD
Grant Turner, MD
Fellows-in-Training NetWork Members
Women’s lung health
Pregnancy in cystic fibrosis
The newest in the line of modulator therapy, Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), is expected to improve life expectancy and quality of life for patients with cystic fibrosis (CF). This evolution in therapy will shape how providers care for their patients, particularly women of reproductive age. Conventionally, women with significantly impaired lung function due to CF have been advised to avoid pregnancy due to potential complications for mother and baby. It is likely that now, with improved lung function while receiving Trikafta, more women will feel better equipped to attempt pregnancy.
There are several considerations in this setting, including the need for careful drug safety and monitoring, creating a plan of action for possible decline in lung function while off certain CF-related medications, and counseling on drug interactions during lactation. In our experience with women becoming pregnant while receiving Trikafta or contemplating pregnancy, all have opted to discontinue modulator therapy with declines in lung function. Trikafta does not report teratogenicity based on animal studies of the individual components of the drug; however, ivacaftor is known to cause impairment in fertility and reproductive indices, including nonviable embryos and implantation failure in a rat model at five times the maximum recommended human dose, dosed prior to and during early embryogenesis. Small mammal models have decreased birth weight at high doses of elexacaftor, tezacaftor and ivacaftor administered individually. There is evidence of placental transfer of ivacaftor and breast milk concentrations of tezacaftor and ivacaftor are higher than plasma concentrations in rats. There are no human data in parturient or lactating women or infants. Three women became pregnant during the phase 3 clinical study of Trikafta, one with elective termination, one pregnancy was carried to full term with normal birth outcome, and one ended in a spontaneous abortion, which was deemed not to be related to the study drug. Translating this information into recommendations for patients has important implications.
Debasree Banerjee, MD, MS
Steering Committee Member
Disaster response and global health
One step forward, two back…
No adult alive today will live to see global gender parity. The 2020 World Economic Forum Global Gender Gap Report, published December 2019, assessed four dimensions of gender inequality – health, economic opportunities, educational advancement, and political empowerment.
The report stated that despite some advances, overall global gender parity would not be reached for 99 years. The gender gap is not solely a developing nation’s problem. The US standing as the 51st in gender parity fell to 53rd during the previous 2-year period. And these numbers were before Covid COVID-19.
Disasters, including pandemics, negatively affect female subjects disproportionately. Covid COVID-19 has unmasked and exacerbated both gender and minority disparity. Global health care workers (HCW) are overwhelmingly female, exposing them to a higher risk of contagion. This risk was exceptionally high among Black, Asian, and minority ethnic HCW (Nguyen et al. Lancet Public Health. 2020;5[9]:E475). The gender pay gap, where women are paid 80% of their male counterparts and women of color make 63%, has led to a greater financial burden among female HCW during Covid COVID-19. Women, including HCW, provide the majority of the unpaid work, i.e., childcare, elder care, and home care. 2020 saw an unprecedented loss of women in the workplace, including health care. Both clinical practice and research have been affected. The long- term effect on women HCW careers is unknown at present. Global gross domestic product growth loss due to this decline in the female workforce is estimated at 1 trillion USD over the next decade.
Disaster and gender parity are entwined. Covid COVID-19 has revealed the persistence of inequalities that nees to be considered in future disaster planning.
Mary Jane Reed, MD, FCCP
Steering Committee Ex-Officio
Interstitial and diffuse lung disease
Emergence and benefits of home monitoring and telemedicine for patients with ILD
Patients with interstitial lung disease (ILD) require regular monitoring with outpatient clinic visits and pulmonary function tests.
The emergence of COVID-19 forced an unprecedented transition to telemedicine and a new reliance on home monitoring. Home spirometry enables quick detection of rapidly progressive disease and is more sensitive than hospital-based spirometry in predicting prognosis (Russel, et al. Am J Respir Crit Care Med. 2016;194[8]:989). Patients with idiopathic pulmonary fibrosis randomized to a home monitoring program had improved psychological wellbeing and higher patient satisfaction with individually tailored treatment decisions (Moor, et al. Am J Respir Crit Care Med. 2020;202[3]:393). However, there are some inaccuracies in home monitoring. For instance, pulse oximetry is less reliable in African American patients receiving supplemental oxygen (Sjoding, et al. N Engl J Med. 2020;383:2477). It is critical to protect ILD patients from potential COVID-19 exposure given the high risk of serious complications. Telemedicine should be offered to all patients and may actually increase access to care in ILD patients, a population with disabling dyspnea and supplemental oxygen needs that requires specialist care unavailable in many geographic regions. African American patients, those older than 65, and patients with lower socioeconomic status are less willing to engage in videoconferencing (Fischer, et al. JAMA Netw Open. 2020;3[10]:e2022302). It is essential that telephone visits be offered to minimize disparities in access to care. Many telemedicine platforms enable caregivers and family members to attend visits from separate locations and provide a unique opportunity to address advance care planning. In-person visits should be arranged for patients with no access to internet or telephone or those with poor medical literacy or insufficient social support to conduct a productive remote visit. Telemedicine and home monitoring have proved invaluable during the COVID-19 pandemic and have the potential to continually increase access to and quality of care.
Rebecca Anna Gersten, MD
Steering Committee Member
Practice operations
Use of media platforms to eliminate the COVID-19 infodemic
We were shocked when we read a tweet in December 2020 from a health care worker stating, “My biggest concern is the lack of data and the quick development time. Feels like we are a bunch of guinea pigs” in reference to the new COVID-19 vaccine.
I reflected back on the last pandemic in 2009, H1N1, and remembered when the new vaccine developed in 174 days was first released to pregnant women and children after phase 3 trials. How did we get here? What do we do to fix it?
This misinformation is labeled as the “COVID-19 infodemic.” In the last year, we have seen the media, more specifically social platforms, quickly spread medical misinformation. In the book “Made to Stick: Why Some Ideas Survive and Some Die,” the authors described core elements that make an idea “sticky.” Use of those exact same sticky techniques can be used to circulate accurate information and to halt the spread of this infodemic. Although, numerous media companies, including Twitter, are making an effort to remove the false content from their platforms, their efforts require a lengthy process and are delayed. Therefore, it is crucial for the public health figures and community at large in partnership with various national organizations to establish a robust connection with the social platforms in a dynamic and timely fashion to help spread the verified information across social media, digital and traditional media outlets.
The UN has launched an initiate called “Verified.” This is a worldwide effort to help individuals spread reliable information regarding COVID-19 to their friends and families via social platforms as various media platforms and businesses have partnered with Verified. Also, we encourage our members to access the CHEST COVID-19 resource center and benefit from the various clinical and practice management tools along with validated patient information materials.
Roozera Khan, DO, FCCP
Steering Committee Member
Humayun Anjum, MD, FCCP
Chair
References
1. The Lancet Infectious Diseases-Editorial. The COVID-19 infodemic. Lancet Infect Dis. 2020;20(8):875.
2. Tangcharoensathien V, et al. Framework for managing the COVID-19 infodemic: methods and results of an online, crowdsourced WHO technical consultation. J Med Internet Res. 2020;22e19659.
3. Verified. https://shareverified.com/en/about. Accessed Feb 18, 2021.
Transplant
COVID-19 + lung transplant
The COVID-19 pandemic has created a dilemma for lung transplantation, with a new group of patients with refractory respiratory failure secondary to the viral illness. As transplant centers worldwide receive referrals for COVID-19 related respiratory failure, information regarding evaluation, listing, and posttransplant care continues to be published, but further research will be needed to care for this complex population.
The first lung transplant for COVID-19 in the United States occurred at Northwestern Hospital on June 5th, 2020,and was publicized for its innovativeness. Information from their three lung transplants completed thus far includes information regarding pathologic findings of the explanted lung tissue; pulmonary fibrosis was the dominant feature, suggesting COVID-19-induced acute respiratory distress syndrome with prolonged time supported by mechanical support may only be survivable with the use of lung transplant (Bharat, et al. Sci Transl Med. 2020;12(574):eabe4282).
Lung transplant in the setting of COVID-19 fibrosis increases surgical complexity as well, with case reports of dense adhesions and distortion of regular surgical planes (Bharat, et al. Sci. Transl. Med. 2020; Lang, et al. Lancet Respir Med. 2020;8:1057). Recognizing the difficulty with deciding to use transplantation after an infectious disease, The International Society for Heart and Lung Transplant (ISHLT) has created guidelines regarding indications for transplantation (ISHLT.org). Continued research will be necessary to identify those at the highest likelihood for success from transplantation, preparation for the increased complexity, and long-term outcomes. Further information is available in a CHEST webinar titled “Lung Transplantation in the Era of COVID-19” .
Clauden Louis, MD
Grant Turner, MD
Fellows-in-Training NetWork Members
Women’s lung health
Pregnancy in cystic fibrosis
The newest in the line of modulator therapy, Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), is expected to improve life expectancy and quality of life for patients with cystic fibrosis (CF). This evolution in therapy will shape how providers care for their patients, particularly women of reproductive age. Conventionally, women with significantly impaired lung function due to CF have been advised to avoid pregnancy due to potential complications for mother and baby. It is likely that now, with improved lung function while receiving Trikafta, more women will feel better equipped to attempt pregnancy.
There are several considerations in this setting, including the need for careful drug safety and monitoring, creating a plan of action for possible decline in lung function while off certain CF-related medications, and counseling on drug interactions during lactation. In our experience with women becoming pregnant while receiving Trikafta or contemplating pregnancy, all have opted to discontinue modulator therapy with declines in lung function. Trikafta does not report teratogenicity based on animal studies of the individual components of the drug; however, ivacaftor is known to cause impairment in fertility and reproductive indices, including nonviable embryos and implantation failure in a rat model at five times the maximum recommended human dose, dosed prior to and during early embryogenesis. Small mammal models have decreased birth weight at high doses of elexacaftor, tezacaftor and ivacaftor administered individually. There is evidence of placental transfer of ivacaftor and breast milk concentrations of tezacaftor and ivacaftor are higher than plasma concentrations in rats. There are no human data in parturient or lactating women or infants. Three women became pregnant during the phase 3 clinical study of Trikafta, one with elective termination, one pregnancy was carried to full term with normal birth outcome, and one ended in a spontaneous abortion, which was deemed not to be related to the study drug. Translating this information into recommendations for patients has important implications.
Debasree Banerjee, MD, MS
Steering Committee Member
Disaster response and global health
One step forward, two back…
No adult alive today will live to see global gender parity. The 2020 World Economic Forum Global Gender Gap Report, published December 2019, assessed four dimensions of gender inequality – health, economic opportunities, educational advancement, and political empowerment.
The report stated that despite some advances, overall global gender parity would not be reached for 99 years. The gender gap is not solely a developing nation’s problem. The US standing as the 51st in gender parity fell to 53rd during the previous 2-year period. And these numbers were before Covid COVID-19.
Disasters, including pandemics, negatively affect female subjects disproportionately. Covid COVID-19 has unmasked and exacerbated both gender and minority disparity. Global health care workers (HCW) are overwhelmingly female, exposing them to a higher risk of contagion. This risk was exceptionally high among Black, Asian, and minority ethnic HCW (Nguyen et al. Lancet Public Health. 2020;5[9]:E475). The gender pay gap, where women are paid 80% of their male counterparts and women of color make 63%, has led to a greater financial burden among female HCW during Covid COVID-19. Women, including HCW, provide the majority of the unpaid work, i.e., childcare, elder care, and home care. 2020 saw an unprecedented loss of women in the workplace, including health care. Both clinical practice and research have been affected. The long- term effect on women HCW careers is unknown at present. Global gross domestic product growth loss due to this decline in the female workforce is estimated at 1 trillion USD over the next decade.
Disaster and gender parity are entwined. Covid COVID-19 has revealed the persistence of inequalities that nees to be considered in future disaster planning.
Mary Jane Reed, MD, FCCP
Steering Committee Ex-Officio
Interstitial and diffuse lung disease
Emergence and benefits of home monitoring and telemedicine for patients with ILD
Patients with interstitial lung disease (ILD) require regular monitoring with outpatient clinic visits and pulmonary function tests.
The emergence of COVID-19 forced an unprecedented transition to telemedicine and a new reliance on home monitoring. Home spirometry enables quick detection of rapidly progressive disease and is more sensitive than hospital-based spirometry in predicting prognosis (Russel, et al. Am J Respir Crit Care Med. 2016;194[8]:989). Patients with idiopathic pulmonary fibrosis randomized to a home monitoring program had improved psychological wellbeing and higher patient satisfaction with individually tailored treatment decisions (Moor, et al. Am J Respir Crit Care Med. 2020;202[3]:393). However, there are some inaccuracies in home monitoring. For instance, pulse oximetry is less reliable in African American patients receiving supplemental oxygen (Sjoding, et al. N Engl J Med. 2020;383:2477). It is critical to protect ILD patients from potential COVID-19 exposure given the high risk of serious complications. Telemedicine should be offered to all patients and may actually increase access to care in ILD patients, a population with disabling dyspnea and supplemental oxygen needs that requires specialist care unavailable in many geographic regions. African American patients, those older than 65, and patients with lower socioeconomic status are less willing to engage in videoconferencing (Fischer, et al. JAMA Netw Open. 2020;3[10]:e2022302). It is essential that telephone visits be offered to minimize disparities in access to care. Many telemedicine platforms enable caregivers and family members to attend visits from separate locations and provide a unique opportunity to address advance care planning. In-person visits should be arranged for patients with no access to internet or telephone or those with poor medical literacy or insufficient social support to conduct a productive remote visit. Telemedicine and home monitoring have proved invaluable during the COVID-19 pandemic and have the potential to continually increase access to and quality of care.
Rebecca Anna Gersten, MD
Steering Committee Member
Practice operations
Use of media platforms to eliminate the COVID-19 infodemic
We were shocked when we read a tweet in December 2020 from a health care worker stating, “My biggest concern is the lack of data and the quick development time. Feels like we are a bunch of guinea pigs” in reference to the new COVID-19 vaccine.
I reflected back on the last pandemic in 2009, H1N1, and remembered when the new vaccine developed in 174 days was first released to pregnant women and children after phase 3 trials. How did we get here? What do we do to fix it?
This misinformation is labeled as the “COVID-19 infodemic.” In the last year, we have seen the media, more specifically social platforms, quickly spread medical misinformation. In the book “Made to Stick: Why Some Ideas Survive and Some Die,” the authors described core elements that make an idea “sticky.” Use of those exact same sticky techniques can be used to circulate accurate information and to halt the spread of this infodemic. Although, numerous media companies, including Twitter, are making an effort to remove the false content from their platforms, their efforts require a lengthy process and are delayed. Therefore, it is crucial for the public health figures and community at large in partnership with various national organizations to establish a robust connection with the social platforms in a dynamic and timely fashion to help spread the verified information across social media, digital and traditional media outlets.
The UN has launched an initiate called “Verified.” This is a worldwide effort to help individuals spread reliable information regarding COVID-19 to their friends and families via social platforms as various media platforms and businesses have partnered with Verified. Also, we encourage our members to access the CHEST COVID-19 resource center and benefit from the various clinical and practice management tools along with validated patient information materials.
Roozera Khan, DO, FCCP
Steering Committee Member
Humayun Anjum, MD, FCCP
Chair
References
1. The Lancet Infectious Diseases-Editorial. The COVID-19 infodemic. Lancet Infect Dis. 2020;20(8):875.
2. Tangcharoensathien V, et al. Framework for managing the COVID-19 infodemic: methods and results of an online, crowdsourced WHO technical consultation. J Med Internet Res. 2020;22e19659.
3. Verified. https://shareverified.com/en/about. Accessed Feb 18, 2021.
Transplant
COVID-19 + lung transplant
The COVID-19 pandemic has created a dilemma for lung transplantation, with a new group of patients with refractory respiratory failure secondary to the viral illness. As transplant centers worldwide receive referrals for COVID-19 related respiratory failure, information regarding evaluation, listing, and posttransplant care continues to be published, but further research will be needed to care for this complex population.
The first lung transplant for COVID-19 in the United States occurred at Northwestern Hospital on June 5th, 2020,and was publicized for its innovativeness. Information from their three lung transplants completed thus far includes information regarding pathologic findings of the explanted lung tissue; pulmonary fibrosis was the dominant feature, suggesting COVID-19-induced acute respiratory distress syndrome with prolonged time supported by mechanical support may only be survivable with the use of lung transplant (Bharat, et al. Sci Transl Med. 2020;12(574):eabe4282).
Lung transplant in the setting of COVID-19 fibrosis increases surgical complexity as well, with case reports of dense adhesions and distortion of regular surgical planes (Bharat, et al. Sci. Transl. Med. 2020; Lang, et al. Lancet Respir Med. 2020;8:1057). Recognizing the difficulty with deciding to use transplantation after an infectious disease, The International Society for Heart and Lung Transplant (ISHLT) has created guidelines regarding indications for transplantation (ISHLT.org). Continued research will be necessary to identify those at the highest likelihood for success from transplantation, preparation for the increased complexity, and long-term outcomes. Further information is available in a CHEST webinar titled “Lung Transplantation in the Era of COVID-19” .
Clauden Louis, MD
Grant Turner, MD
Fellows-in-Training NetWork Members
Women’s lung health
Pregnancy in cystic fibrosis
The newest in the line of modulator therapy, Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), is expected to improve life expectancy and quality of life for patients with cystic fibrosis (CF). This evolution in therapy will shape how providers care for their patients, particularly women of reproductive age. Conventionally, women with significantly impaired lung function due to CF have been advised to avoid pregnancy due to potential complications for mother and baby. It is likely that now, with improved lung function while receiving Trikafta, more women will feel better equipped to attempt pregnancy.
There are several considerations in this setting, including the need for careful drug safety and monitoring, creating a plan of action for possible decline in lung function while off certain CF-related medications, and counseling on drug interactions during lactation. In our experience with women becoming pregnant while receiving Trikafta or contemplating pregnancy, all have opted to discontinue modulator therapy with declines in lung function. Trikafta does not report teratogenicity based on animal studies of the individual components of the drug; however, ivacaftor is known to cause impairment in fertility and reproductive indices, including nonviable embryos and implantation failure in a rat model at five times the maximum recommended human dose, dosed prior to and during early embryogenesis. Small mammal models have decreased birth weight at high doses of elexacaftor, tezacaftor and ivacaftor administered individually. There is evidence of placental transfer of ivacaftor and breast milk concentrations of tezacaftor and ivacaftor are higher than plasma concentrations in rats. There are no human data in parturient or lactating women or infants. Three women became pregnant during the phase 3 clinical study of Trikafta, one with elective termination, one pregnancy was carried to full term with normal birth outcome, and one ended in a spontaneous abortion, which was deemed not to be related to the study drug. Translating this information into recommendations for patients has important implications.
Debasree Banerjee, MD, MS
Steering Committee Member