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Zimbabwe's Anti-Retroviral Therapy coverage stands at 99%
11 Jan 2024 at 05:14hrs | Views
AN international HIV and Aids organisation based in the United Kingdom has commended Zimbabwe for approving two new HIV prevention products within six months before any other African nation.
The country, which has an HIV prevalence of 11,8 percent, has made several strides in preventing and treating HIV, having met global targets of ensuring that at least 95 percent of those living with HIV know their status, are on treatment and achieve viral suppression.
Zimbabwe's Anti-Retroviral Therapy coverage stands at 99 percent of the 1,3 million HIV-positive people.
To address the high burden, the Joint United Nations Programme on HIV/Aids (UNAids) has come up with the 95-95-95 targets, which means that 95 percent of people on treatment have their viral load undetectable, while 95 percent of all HIV-positive people know their status and 95 percent of those who know their status are on treatment.
Over the past 10 years, Zimbabwe has recorded the highest decline of 78 percent in new HIV infections in Eastern and Southern Africa, making the country a trendsetter in HIV prevention and treatment.
The two preventive products include the vaginal ring and the injectable, which are part of pre-exposure prophylaxis (PrEP), which is highly effective in preventing HIV.
The DPV-VR, a female-initiated option to reduce the risk of HIV infection must be worn inside the vagina for 28 days, after which it should be replaced by a new ring.
The ring is made of silicone and is easy to bend and insert. It works by releasing the antiretroviral drug, Dapivirine, from the ring into the vagina slowly over 28 days.
Besides the injectable and vaginal ring, Zimbabweans also have a choice to take the oral PrEP.
This is part of a comprehensive HIV prevention package of services in Zimbabwe and is to be used in conjunction with other methods of prevention such as female and male condoms, voluntary medical male circumcision and HIV testing and counselling.
In a report, Aids Map said Zimbabwe had shown other countries how to make new HIV prevention products available quickly by having the Dapivirine vaginal ring and long-acting cabotegravir PrEP each approved in less than six months.
"In Zimbabwe, the International Partnerships for Microbicides moved quickly to seek approval for the Dapivirine vaginal ring after WHO pre-qualification, submitting its registration dossier in February 2021," reads the report.
"As clinical trials leading to the approval of the Dapivirine vaginal ring had taken place in Zimbabwe, the Medicines Control Agency of Zimbabwe was already familiar with the product. "They decided to use the European Medicines Agency approval and WHO pre-qualification as the basis for an ‘abridged review', a fast-track process that enabled approval on 6 July 2021, the first national approval of the Dapivirine vaginal ring in the world."
While it took 1 045 days to grant approval of tenofovir disoproxil/emtricitabine in Zimbabwe in 2009, the Dapivirine vaginal ring took 133 days and long-acting cabotegravir took 159 days to receive approval, says Aids Map.
The US Food and Drug Administration approved cabotegravir for PrEP in December 2021 and the World Health Organisation recommended it as an additional HIV prevention option in March 2022.
It was submitted for registration in Zimbabwe in January 2022.
"The Medicines Control Agency of Zimbabwe decided that because cabotegravir had already been approved by the US FDA, it could undergo expedited review in Zimbabwe and it was approved on 6 July 2022," reads the report.
The organisation has attributed the progress to strategies that enabled Zimbabwe to move quickly in rolling out the life-saving interventions.
These include an existing policy of using regulatory approval by a stringent authority such as the US FDA or EMA to trigger an expedited review pathway.
"Close collaboration between clinical trials review and product review divisions of the Medicines Control Agency promoted familiarity with the products under review is also part of strategies used," it said.
"WHO pre-qualification was a guarantee of product quality and avoided the need for time-consuming manufacturing and product inspections, which saw Zimbabwe approving the two quicker."
Zimbabwe is among the top countries in the world that have halved Aids-related deaths in the past three decades and was also recently removed from the list of 30 TB highly burdened countries worldwide.
The country, which has an HIV prevalence of 11,8 percent, has made several strides in preventing and treating HIV, having met global targets of ensuring that at least 95 percent of those living with HIV know their status, are on treatment and achieve viral suppression.
Zimbabwe's Anti-Retroviral Therapy coverage stands at 99 percent of the 1,3 million HIV-positive people.
To address the high burden, the Joint United Nations Programme on HIV/Aids (UNAids) has come up with the 95-95-95 targets, which means that 95 percent of people on treatment have their viral load undetectable, while 95 percent of all HIV-positive people know their status and 95 percent of those who know their status are on treatment.
Over the past 10 years, Zimbabwe has recorded the highest decline of 78 percent in new HIV infections in Eastern and Southern Africa, making the country a trendsetter in HIV prevention and treatment.
The two preventive products include the vaginal ring and the injectable, which are part of pre-exposure prophylaxis (PrEP), which is highly effective in preventing HIV.
The DPV-VR, a female-initiated option to reduce the risk of HIV infection must be worn inside the vagina for 28 days, after which it should be replaced by a new ring.
The ring is made of silicone and is easy to bend and insert. It works by releasing the antiretroviral drug, Dapivirine, from the ring into the vagina slowly over 28 days.
Besides the injectable and vaginal ring, Zimbabweans also have a choice to take the oral PrEP.
This is part of a comprehensive HIV prevention package of services in Zimbabwe and is to be used in conjunction with other methods of prevention such as female and male condoms, voluntary medical male circumcision and HIV testing and counselling.
In a report, Aids Map said Zimbabwe had shown other countries how to make new HIV prevention products available quickly by having the Dapivirine vaginal ring and long-acting cabotegravir PrEP each approved in less than six months.
"In Zimbabwe, the International Partnerships for Microbicides moved quickly to seek approval for the Dapivirine vaginal ring after WHO pre-qualification, submitting its registration dossier in February 2021," reads the report.
"As clinical trials leading to the approval of the Dapivirine vaginal ring had taken place in Zimbabwe, the Medicines Control Agency of Zimbabwe was already familiar with the product. "They decided to use the European Medicines Agency approval and WHO pre-qualification as the basis for an ‘abridged review', a fast-track process that enabled approval on 6 July 2021, the first national approval of the Dapivirine vaginal ring in the world."
While it took 1 045 days to grant approval of tenofovir disoproxil/emtricitabine in Zimbabwe in 2009, the Dapivirine vaginal ring took 133 days and long-acting cabotegravir took 159 days to receive approval, says Aids Map.
The US Food and Drug Administration approved cabotegravir for PrEP in December 2021 and the World Health Organisation recommended it as an additional HIV prevention option in March 2022.
It was submitted for registration in Zimbabwe in January 2022.
"The Medicines Control Agency of Zimbabwe decided that because cabotegravir had already been approved by the US FDA, it could undergo expedited review in Zimbabwe and it was approved on 6 July 2022," reads the report.
The organisation has attributed the progress to strategies that enabled Zimbabwe to move quickly in rolling out the life-saving interventions.
These include an existing policy of using regulatory approval by a stringent authority such as the US FDA or EMA to trigger an expedited review pathway.
"Close collaboration between clinical trials review and product review divisions of the Medicines Control Agency promoted familiarity with the products under review is also part of strategies used," it said.
"WHO pre-qualification was a guarantee of product quality and avoided the need for time-consuming manufacturing and product inspections, which saw Zimbabwe approving the two quicker."
Zimbabwe is among the top countries in the world that have halved Aids-related deaths in the past three decades and was also recently removed from the list of 30 TB highly burdened countries worldwide.
Source - The Chronicle
