THE prevailing COVID-19 pandemic will not affect rollout of the Dapivirine ring or Vaginal ring, an HIV prevention ring for women, HIV expert and histopathologist who was also the Dapirivirine ring study chairperson in Africa, Dr Nyaradzo Mgodi has said.
By Michael Gwarisa
Dr Mugodi’s comments come at the back of indications that COVID-19 could have disrupted access to healthcare services and rollout of certain programs across the globe over the past 12 months.
In an interview with HealthTimes, Dr Mgodi said the ring has already received its pre-qualification from the World Health Organisation (WHO) to determine its safety and efficacy.
In general, I do not think that the COVID-19 pandemic will adversely affect the plans for the ring roll out. As you know, work is going on in the back ground. After the positive EMA opinion of July 2020, in November 2020, WHO prequalified the ring, a process to facilitate access to medicines. Pre-qualification involves evaluating whether a medicine meets global standards for quality, safety and efficacy. Many African national regulatory agencies consider WHO pre-qualification as they review new products.
“The positive opinion also recommended a post-authorization efficacy study to better understand efficacy among cisgender women aged 18-25, and to complement existing data on potential drug resistance. We are currently conducting the studies in young women. Though C-19 has impacted our operations, I cant say there has been a major detrimental effect,” said Dr Mgodi.
Rollout of the ring in Zimbabwe was scheduled to take off once the licensing and post-authorization efficacy study of the ring were completed later this year. The Dapirivirin or Vaginal ring is a silicon vaginal ring containing the antiretroviral, dapivirine which is inserted monthly into a woman’s vagina where it releases the drug slowly, in the process, preventing HIV infection. The ring is replaced each month with a new one filled with the drug.
Dr Mugodi added that the Dapivirine Ring is currently being reviewed by the WHO for possible inclusion in its guidelines on HIV treatment and prevention: Updates to the guidelines are expected early in 2021.
“International Partnership for Microbicides (IPM) is also applying for the ring to be reviewed by countries in sub-Saharan Africa, where women face persistently high HIV risk. Initial submissions are planned for Eswatini, Kenya, Lesotho, Malawi, Rwanda, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. IPM also plans to submit the ring to the US FDA. For the latest information. I am not sure if the application to Medicines Control Authority of Zimbabwe has already been made
“So what I have described above are the on-going processes. Once registered by MCAZ, I am sure the MoHCC will start with sentinel sites like what was done for Truvada. I hope the roll out will piggy back on the currently existing sexual reproductive health services like contraception provision, STI testing/treatment, cervical cancer screening, oral PrEP. So at the moment I have no major concerns about C-19 disrupting the roll out.”
Young women aged 16-21 in South Africa, Uganda and Zimbabwe are currently participating in REACH, a study of the ring and oral PrEP that is designed to collect additional safety information among this age group, and to understand their HIV prevention needs and preferences related to these two products.