The Sunday Mail
Rudo Mandiro
THE Medicines Control Authority of Zimbabwe (MCAZ) recently approved use of the long-acting injectable cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV prevention, making the country the first in Africa to do so.
Cabotegravir (CAB-LA) is a long-term HIV injectable pre-exposure prophylaxis (PrEP), which is expected to reduce the risk of getting HIV infection by 79 percent if compared to oral PrEP.
Until Zimbabwe’s regulatory approval, only two high-income countries had given it regulatory approval.
The US Food and Drug Administration (FDA) approved its use for HIV prevention in December 2021, and Australia’s Therapeutic Goods Administration (TGA) approved it in August 2022.
Following the announcement, MCAZ head of evaluations and registration, Mr Farai Masekela, was quoted as saying information submitted to support the approval of the product indicated that the product is safe, effective, and of good quality.
“MCAZ is confident that the product will benefit those who receive it,” said Mr Masekela.
The development came as good news, especially for women who carry the burden of HIV and AIDS.
It is expected to reduce the risk of getting HIV infection by 79 percent when compared to oral PrEP, which is prescribed as daily pills.
Women interviewed by The Sunday Mail Online welcomed the approval of CAB-LA saying it brings hope, and will go a long way in reducing the chances of HIV infections.
Pan African Positive Women’s Coalition Zimbabwe (PAPWC-ZIM) national director, Mrs Tendayi Westerhof, hopes policies to guide its rollout are put in place, and that the drug will be funded through domestic health financing and other funding models such as the Global Fund.
“This victory calls for celebration, as it has led to a significant reduction of HIV transmission and related deaths.
“As communities, we continue with the advocacy for the speedy accessibility of the drug, because HIV prevention is a priority,” said Mrs Westerhorf, who is also the National AIDS Council (NAC) board member representative of persons living with HIV.
A TB champion for StopTB Partnership Zimbabwe and Global Fund coordinating committee member, Ms Tariro Kutadza, said more research and development should continue to come up with long-live injections.
“We really appreciate the short-term injections, and hope they will be affordable, available, and tolerant to the users with minimal side effects,” she said.
NAC chief executive officer, Dr Bernard Madzima, said the approval by the regulatory authority for the long-term injectable PrEP comes as a game changer in the HIV prevention fight.
“We are working with the Ministry of Health and Child Care, World Health Organisation (WHO), and other stakeholders who include people with HIV, towards a roadmap to implementation in the country.
“As we stand, the injection is not yet accessible in the hospitals or health facilities and once the procedures are done, information will be shared with the users.”
Executive director of the Community Working Group on Health (CWGH), Mr ltai Rusike, said the cabotegravir long HIV injectable PrEP will give people a choice when it comes to prevention.
“The Government should now make sure that the PrEP is widely available and easily accessible to all our health institutions,” said Mr Rusike.
Dr Rusike said CWGH welcomes the approval by the Government of Zimbabwe to use cabotegravir for PrEP.
“It is very encouraging that Zimbabwe has become one of the first countries in Africa to approve the use of cabotegravir long HIV injectable that has been proven to be efficient in HIV prevention.”
The World Health Organisation says PrEP will dramatically reduce the risk of HIV acquisition for women, as well as men.
In a statement, WHO recommended that CAB-LA may be offered to people at substantial risk of HIV infection, as part of comprehensive HIV prevention approaches.
“Two large studies showed that CAB-LA injections every two months were safe, well-tolerated, and highly effective in reducing the risk of HIV acquisition.
WHO released comprehensive guidelines, calling for countries to consider this effective prevention option, and highlighted the need for implementation science to support its introduction.
CAB-LA is the third PrEP product recommended by WHO for HIV prevention,” the statement read.
WHO said Tenofovir-based oral PrEP was recommended in 2015, and the dapivirine vaginal ring – another long-acting product – in 2021, adding that the availability of these three products provides increased choices for HIV prevention.
Director of WHO’s Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, Dr Meg Doherty, welcomed the news.
“WHO welcomes the news that Zimbabwe has approved the use of CAB-LA, which will pave the way for its use, providing more safe and effective options for HIV prevention,” said Dr Doherty.
According to AIDS Vaccine Advocacy Coalition (AVAC), two studies, HPTN 083 and HPTN 084, have shown high levels of protection using cabotegravir as a long-acting injectable (CAB-LA).
HPTN 083 gathered data among men who have sex with men, transgender women, while HPTN 084 investigated the same product among cisgender women.
UNAIDS also points out the CAB-LA option could be a game-changer for the HIV response.
According to UNAIDS, this makes PrEP simpler or less burdensome for all genders.
“This may also circumvent the stigma associated with daily oral therapy and improve correct dosing and adherence, which is critical for PrEP effectiveness,” said UNAIDS in a statement.
The Sub-Saharan Africa region has the most HIV cases globally.
In this part of the world, heterosexual activities are said to be the main cause, and as a result affect adult women the most.
In Zimbabwe, the HIV epidemic is generalised and largely driven by unprotected heterosexual sex.
Several interventions, like antiretroviral therapy among others, have been used to keep HIV and AIDS at bay.
Anti-retroviral drugs have been a game-changer.
People who are diagnosed early have been accessing them in both rural and urban, public and private health facilities across Zimbabwe.
The addition of CAB-LA brings hope to many who have been waiting for discreet HIV prevention methods.
