News / Health
Pregnant women can use PrEP- study
16 Jul 2021 at 02:30hrs | Views
PREGNANT women who are HIV negative can use the Dapivirine ring and oral Truvada as a means to prevent HIV infection in the last stages of their pregnancies, a recent study has revealed.
It is estimated that a woman is three times more likely to contract HIV during pregnancy than any other period hence the need to prevent infection while pregnant.
The two Antiretrovirals, Dapivirine and Truvada are used as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection.
The DELIVER (MTN-042) study to assess the effectiveness of the ring and Truvada in pregnant women who are in the eighth and ninth month was conducted in Zimbabwe, Malawi, South Africa and Uganda as Sub Saharan Africa is highly burdened with HIV/AIDS especially women.
Zengeza Clinical Research Site in Harare is one of the four sites in the world conducting the United States National Institutes of Health funded DELIVER (MTN-042) phase (iiib) study evaluating the safety and acceptability of Truvada as daily oral PrEP and monthly Dapivirine ring in pregnant women.
Dr Nyaradzo Mgodi the Principal Investigator at the University of Zimbabwe's Clinical Trials Research Centre announced that the research they conducted yielded positive results and said the results were an important milestone in the prevention of HIV infection.
"We are pleased to inform you that the Interim Review Panel (an independent panel of experts who review safety data) found no safety concerns in its review of data from the first cohort of participants – women who were 36-37 weeks (8-9 months) into their pregnancies at the time they enrolled – and as such, recommended the study proceed with enrollment of Cohort two," she said.
Dr Mgodi said Cohort two participants will consist of 150 women who will be slightly earlier in pregnancy, about 30-35 weeks gestation or 7-8 months. They anticipate being ready to begin this next phase of the study by early to mid-July.
The IRP includes specialists in pediatrics, obstetrics and gynecology, public health, nursing and ethics from both Africa and North America.
To assess the safety of the Dapivirine ring and oral PrEP, they looked at the pregnancy outcomes and any complications experienced by study participants and whether these occurred with similar frequency for what is expected for women locally.
Dr Mgodi explained that in response to the urgent need for information about the safety of these products during pregnancy – particularly, the dapivirine ring – study design modifications have been made that will make for less time to complete the study, and thus, expedite the availability of final results.
"As originally designed, DELIVER was to enroll 750 women across four groups, or cohorts. With the protocol amendment, DELIVER will instead enroll a total of 550 women across three groups, the third group being 250 women who are between 12 and 29 weeks gestation (3 -7 months pregnant), 200 of whom will be assigned to use the dapivirine ring. Importantly, these changes do not compromise the scientific integrity of the study nor impact the many safety measures already in place," she noted.
Dr Mgodi said women who enroll in the study are randomly assigned to use either oral PrEP or the ring until the time they deliver. To ensure the safety of participants, the study is being conducted in stepwise fashion, enrolling one group at a time, beginning with women late in pregnancy, when the potential risks from drug exposure are lowest.
Its sister study, B-PROTECTED (MTN-043), which is evaluating the safety and acceptability of the dapivirine ring and Truvada as oral PrEP in breastfeeding women and their infants is in the pipeline.
The World Health Organisation announced prequalification of the Dapivirine ring in December 2020 and is set to be available this year for women in sub-Saharan Africa first.
This prequalification means that the ring meets global standards for quality, safety and efficacy and may be used by HIV negative women to ensure they aid themselves in reducing HIV infection.
It is estimated that a woman is three times more likely to contract HIV during pregnancy than any other period hence the need to prevent infection while pregnant.
The two Antiretrovirals, Dapivirine and Truvada are used as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection.
The DELIVER (MTN-042) study to assess the effectiveness of the ring and Truvada in pregnant women who are in the eighth and ninth month was conducted in Zimbabwe, Malawi, South Africa and Uganda as Sub Saharan Africa is highly burdened with HIV/AIDS especially women.
Zengeza Clinical Research Site in Harare is one of the four sites in the world conducting the United States National Institutes of Health funded DELIVER (MTN-042) phase (iiib) study evaluating the safety and acceptability of Truvada as daily oral PrEP and monthly Dapivirine ring in pregnant women.
Dr Nyaradzo Mgodi the Principal Investigator at the University of Zimbabwe's Clinical Trials Research Centre announced that the research they conducted yielded positive results and said the results were an important milestone in the prevention of HIV infection.
"We are pleased to inform you that the Interim Review Panel (an independent panel of experts who review safety data) found no safety concerns in its review of data from the first cohort of participants – women who were 36-37 weeks (8-9 months) into their pregnancies at the time they enrolled – and as such, recommended the study proceed with enrollment of Cohort two," she said.
Dr Mgodi said Cohort two participants will consist of 150 women who will be slightly earlier in pregnancy, about 30-35 weeks gestation or 7-8 months. They anticipate being ready to begin this next phase of the study by early to mid-July.
The IRP includes specialists in pediatrics, obstetrics and gynecology, public health, nursing and ethics from both Africa and North America.
To assess the safety of the Dapivirine ring and oral PrEP, they looked at the pregnancy outcomes and any complications experienced by study participants and whether these occurred with similar frequency for what is expected for women locally.
Dr Mgodi explained that in response to the urgent need for information about the safety of these products during pregnancy – particularly, the dapivirine ring – study design modifications have been made that will make for less time to complete the study, and thus, expedite the availability of final results.
"As originally designed, DELIVER was to enroll 750 women across four groups, or cohorts. With the protocol amendment, DELIVER will instead enroll a total of 550 women across three groups, the third group being 250 women who are between 12 and 29 weeks gestation (3 -7 months pregnant), 200 of whom will be assigned to use the dapivirine ring. Importantly, these changes do not compromise the scientific integrity of the study nor impact the many safety measures already in place," she noted.
Dr Mgodi said women who enroll in the study are randomly assigned to use either oral PrEP or the ring until the time they deliver. To ensure the safety of participants, the study is being conducted in stepwise fashion, enrolling one group at a time, beginning with women late in pregnancy, when the potential risks from drug exposure are lowest.
Its sister study, B-PROTECTED (MTN-043), which is evaluating the safety and acceptability of the dapivirine ring and Truvada as oral PrEP in breastfeeding women and their infants is in the pipeline.
The World Health Organisation announced prequalification of the Dapivirine ring in December 2020 and is set to be available this year for women in sub-Saharan Africa first.
This prequalification means that the ring meets global standards for quality, safety and efficacy and may be used by HIV negative women to ensure they aid themselves in reducing HIV infection.
Source - Sunday News
