South Africa could be one of the last to deploy child-friendly dolutegravir

South Africa could become the last country in Africa to have access to the pediatric formulation of the antiretroviral drug dolutegravir as regulatory lags continue.

2019 South Africa Introduced guidelines Depending on your weight, we recommend dolutegravir-based treatment for adults and children over the age of six.

However, three years later, the country still does not provide widespread access to the drug’s dispersive and child-friendly formulations. Instead, doctors had to apply for access on a case-by-case basis. The South African Health Products Regulatory Authority (SAHPRA), the national regulator, must approve the use of all medicines before they can be used domestically.

Recent SAHPRA approvals have paved the way for generic manufacturers to start offering medicines, but they have not yet been approved. The South African Health Department is currently updating its treatment guidelines to make it available to very young children when the generic version becomes available.

Clinicians say deploying dispersible dolutegravir is the key to treating HIV once a day for South African children and improving their outcomes. This change occurs because some doctors report increased follow-up and malnutrition losses in children living with HIV.

“As clinicians, we want to have access to these medicines as soon as possible,” said Professor Moherndran Archary, a pediatric infectious disease specialist at the University of KwaZulu-Natal. “At present, South Africa will probably be the last accessible country in Africa, and we are the largest source of pediatric antiretroviral drugs.”

Dispersible medicines can be mixed with liquids such as water and juice. These formulations are very important for children who are too old for infant syrups of antiretroviral drugs, but may be too young to swallow adult-sized tablets. Without many dispersive antiretroviral drugs, such children would depend on large doses of syrup multiple times a day.

Today, the Drug Initiative for Non-Profit Ignored Diseases (DNDi) is a distributable combination of four SAHPRA anti-retroviral drugs for infants living with HIV, abacavir, lamivudine, lopinavir, and ritonavir. Announced that it has given prompt approval to. Manufactured by the pharmaceutical company Cipla, the sweet taste combination treatment can be mixed with milk or water or sprinkled on foods such as porridge.

In South Africa, access to the decentralized two-in-one of abacavir and lamivudine is expected to increase. This means that many children will eventually receive once-daily treatment if combined with similarly prescribed dolutegravir.

In the 2021 government, South Africa, about 300,000 children under the age of 15 live with HIV. data show. Just under half of these HIV-positive children are being treatedAnd similar rates are suppressed by the virus — much lower than those found in adults.

Patients rely on clinical access programs amid delayed regulation

Other African countries have introduced child-friendly dolutegravir sooner, says Archery. This is because many have accepted World Health Organization (WHO) approval.

However, South Africa requires SAHPRA to register medicines, and as part of this, there is a need for companies to invent drugs that register their products before processing generics, says Senior Pharmacology Lecturer at Kwazul Natal University. Andy Gray says.

Gray, a regulator company like SAHPRA, is an originator company (Pediatric Dolutegravir, ViiV Healthcare) to provide basic safety and efficacy data for medicines, even if they do not intend to sell the medicines domestically. It explains that it often depends on the case). Second, the generic manufacturer must show that it meets these same criteria.

SAHPRA approved Application for ViiV Healthcare on April 29th. Drug regulators say they are considering applying for two generics of pediatric dolutegravir, but have not specified which company has applied. Nonetheless, two generic manufacturers, Mylan Laboratories and Macleods Pharmaceuticals, hold a voluntary license to manufacture and sell the drug, said Thomas Jenkins, a spokeswoman for ViiV Healthcare.

Since 2018, ViiV Healthcare has partnered with the international nonprofit organization Clinton Health Access Initiative (CHAI) and the drug lending mechanism Unitaid to provide technical support to Mylan and MacLeod. Produce dolutegravir for children..

“We believe that these partnerships will give more access to those who are most in need of 5 mg of decentralized dolutegravir, so we have no plans to commercialize our products in South Africa at this time,” Jenkins said. ..

He adds that ViiV Healthcare offers several pediatric medicines per patient in South Africa as part of its clinical access program until generics are enrolled.

Multiple moves underway to improve access to pediatric HIV treatment

Published by Southern Africa HIV Clinicians Association Archery and Other Infectious Disease Experts New antiretroviral treatment guidance May. Society includes many major HIV professionals who regularly review the latest scientific evidence and make treatment recommendations. Their guidelines have historically been adopted as best practices for the private sector in the region, and especially in South Africa, which heralds a policy shift in the public sector.

When adopted in South Africa, social guidance allows almost any child over the age of 6 to switch to an abacavir / lamivudine / dolutegravir regimen based on their weight. For many, this means taking dolutegravir instead of efavirenz or lopinavir / ritonavir in the current regimen. Some changes in guidance, NADIA When Artist Studies showing that lamivudine can be reused between primary and secondary regimens.

Archery adds that shifts are also supported by data from ODYSSEY trial Dortegravir-based regimens were superior to traditional combinations based on either efavirenz or lopinavir / ritonavir in children About 2 years old..

The South African HIV Clinicians Association is expected to meet with the South African National Health Department to discuss potential changes.

“I thought I saw the end of malnutrition and HIV 10 years ago.”

Meanwhile, the ministry says it is already preparing to provide dolutegravir to younger children under the age of six who are not currently being treated.

Health ministry experts recently approved the addition of pediatric dolutegravir for infants to the country’s list of essential medicines, said State Department spokesman Foster Mohale. Drugs must be included in this list before they can be purchased in bulk for the national public sector or included in treatment guidelines.

According to Mohale, the country is currently updating its HIV treatment guidelines to give very young children widespread access to pediatric dolutegravir in anticipation of the upcoming availability of dispersible formulations.

Currently, the recommended regimens for children under the age of 6 are abacavir / lamivudine and lopinavir / ritonavir. If South Africa moves to allow younger children to take dolutegravir, they will be able to use dolutegravir instead of lopinavir / ritonavir.

Archery working at a major hospital in the port city of Durban sees an increasing number of children lost to fight untraceable, and a move towards better and easier pediatric HIV treatment is coming. increase. South Africa has been hit hard by COVID-19. About 300,000 people died But also with widespread unemployment Increased feeling of hunger. Most of the countries around Durban also witnessed a deadly flood in April.

“We are witnessing system disruptions not only from a social perspective, but also from a healthcare delivery system perspective,” he says. [health] Center due to financial difficulties … We are finding many patients who are lost in the system. “

Archary concludes, “I thought I saw malnutrition and the end of HIV 10 years ago, which is now much more common.”