DEPUTY Director HIV/AIDS and STIs in the ministry of health and child care (MoHCC), Dr Tsitsi Apollo says the country has already commenced its transition process from Tenovir/Lamuvidene/Efavirens to Dolutegravir (DTG), a first line regimen of Antiretroviral Therapy (ART) which has less side effected and a rapid viral suppression.
By Michael Gwarisa
The whole transition process will be completed come February 2020 and in the process, drugs such as Navirapine (NVP) will be phased out with indications on the ground confirming that healthcare providers have already been advised to limit its use.
Briefing a Kocitaf launch event in the capital where new ART drug TLD was also being showcased, Dr Apolo said the transition to DTG did not happen overnight and in as much as Zimbabwe welcomes new innovations and scientific discoveries towards eliminating HIV and AIDS, it will follow due process before transitioning to new guidelines.
“In terms of processes, starting from this month, we have started implementing DTG based regimens, administering it to treatment naïve patients and this will be followed up by other eligible patients in August 2019, so that is the plan.
“When we come up with these new recommendations for a country, we look at a number of aspects, we look at the safety, we look at medicines with minimal adverse effects, we look at possibilities of the drug having good adherence among patients, we look at efficacy of the drug, we look at the non-inferiority studies, we look at the side effects profile, we also look at the availability of the drug, the pill burden of the drug and we also look at harmonisation of treatment across different populations,” said Dr Apollo.
She said Dolutegravir (DTG) was a safe and efficacious drug with a rapid viral suppression, low potential for drug-drug interactions and a high genetic barrier to developing ARV drug resistance. She however advised that it should be given as a preferred first line regimen for Antiretroviral Therapy (ART) naïve patients.
Exposure to DTG at the time of conception for women however may be associated with an increased risk of neural tube defects among infants. DTG should not be go HIV infected pregnant women during their first trimester.
She added that Zimbabwe has processes and very systematic approaches in place to adapt to new evidence and usually we follow normative guidelines by the World Health Organisations (WHO) that usually runs systematic reviews based on different studies. She added that the National Medicines Therapeutic Policy Advisory Committee also helps the ministry in revising the treatment guidelines. There is also an adaptation committee that defines the adaptation guidelines.
“The WHO comes up with some key questions to inform the next guidelines and therefore we rely on those recommendations from WHO and every two to three years, we revise our guidelines in tandem with the evidence.
“There have been multiple transitions for the past couple of year that have been taking place in Zimbabwe. Considering that we have over a million people on treatment, it is very important for us as a public health program to ensure we manage this transition processes very well to ensure there are no stock raptures and we won’t have stock-out of medicines.”
She added that government always consults widely with different stakeholders before adopting a new drug and in the case of DTG, they consulted women living with HIV particularly in the context of its safety.
“We consult with doctors, with clinicians, with the stakeholders and the adaptation committee works closely with National Medicines Therapeutic Policy Advisory Committee that usually help the ministry in revising the treatment guidelines.”
Dr Apolo added that there was need for disseminating adequate information to adolescent girls and young women of childbearing potential of the pros and cons of switching to DTG to ensure they make informed choices about their treatment options.
“Those who not currently want to become pregnant and women who are breastfeeding should be offered a pregnancy test before receiving the preferred regimen containing DTG together with documented evidence of reliable long-term contraceptive method i.e contraceptive implant of progestogen injections.
“Women on DTG who plan to get pregnant should discuss with their health care provider for provision of alternative treatment.”
She also called on health workers to ensure all ART experienced patients should be transitioned to DTG-containing regimen after confirming a suppressed HIV viral load of less than
Meanwhile, defects related to closure of the neural tube occur from conception through the first six weeks of gestation, embryos who are exposed to dolutogravir from time of conception through the first six weeks are at potential risk.
“As a country, we have done very well in terms of scaling- up and rolling out Antiretroviral Therapy (ART) program where we have close to 90 % of the estimated people living with HIV to actually be on treatment. We are looking at 1.1 million people including adults, children, pregnant women, adolescents, breastfeeding mothers that are receiving life from treatment and our endeavour is to retain people on treatment.”
In Zimbabwe, majority of people on treatment are receiving first line treatment and most of these are actually receiving care at the lowest level that is at the clinics and primary care levels in rural and urban centres.
Zimbabwe has a population of 1300 million living with HIV even though the prevalence has been falling over the last two decades in the 15 to 49 age group. The incidence has also come down to 0.48 % based on the population based survey of 2016. Mother to Child Transmission of HIV (MTCT) has also fallen from 30 to 6.7 % and government aims to reduce it to below 5%.
“An EFV –based regimen is safe and effective first line regimen recommended for use by women of childbearing potential who desire to get pregnant or have no effective contraception that is Tenofovir/Lamivudine/Efavirens 400.
“If pregnancy is identified in the first trimester (up to 12/40 gestation), women should switch to Tenofovir/Lamuvudine/Efavirenz 600. Once pregnancy is 12/40 and over, women should switch to Tenofovir/Lamuvidine/ Dolutegravir (TLD) and continue that regimen whole breastfeeding with provisions of effective contraception.”