Uganda is the latest African country to switch to Dolutegravir (DTG) as the first line drug to treat HIV, but women of reproductive age will be excluded from the regimen over fears of potential side effects on unborn babies, experts say.

Developing countries, especially in Africa, have been using Efavirenz-based antiretroviral drugs as the prevention treatment option for HIV, but many are now switching to DTG because of its superior benefits.

DTG has fewer side effects, greater potency against drug resistance and suppresses the viral load faster. A person whose viral load is suppressed has a reduced risk of infecting their sexual partners.

The head of the Aids Control Programme at Uganda’s Health Ministry Dr Joshua Musinguzi said the decision to leave out women of reproductive age (14-49 years) is based on recommendations from the World Health Organisation, following preliminary results of a study conducted in Botswana.

The study found increased risk of birth defects in children born to HIV-positive women who were taking DTG at the time of conception.

Although the report is inconclusive, WHO recommended that women of childbearing age, especially those in the first few weeks of pregnancy, should not take the drug.

“As a safety measure, the ministry decided that only HIV-positive girls under 14, menopausal women and those on long term family planning methods would be eligible for the new drug,” said Dr Musinguzi.

The rest will continue using Efavirenz. All men will also be enrolled on the new drug.

However, health-rights activists say excluding women from a drug with proven benefits is a violation of their rights.

Martha Akello from the International Community of Women Living with HIV/Aids-Eastern Africa said a blanket exclusion of women in the childbearing age group means potential eligible women who would have otherwise benefited from the drug will miss out.

“Not all women in the childbearing age are interested in having babies while others already have the number of children they want. The Ministry needs to look at this issue on a case by case basis instead of placing a total ban,” said Ms Akello.

She said that instead, women should be counselled and given information about the drug and the potential impact it could have, to enable them to make informed choices on their own.

But Dr Musinguzi said the government’s decision is in the best interest of women and their children.

“In setting health guidelines for the country, you use what is called the public approach where you go for the common good. So as a cut off, we have decided that only women outside the reproductive age group will get the new drug,” he said.

He added that even though the study showed that the drug could be safe for use in the later stages of pregnancy, the ministry does not want to take chances.

“We don’t want back and forth issues in terms of planning and also because unlike the developed world where healthcare is individualised, our health facilities may not have the capacity to handle women with different needs,” said Dr Musinguzi.

The DTG rollout will be conducted in a phased manner, starting this September. All eligible people are expected to have switched to the new drug by December 2019. The drug will cost an estimated $6.5 per person per month compared with the EFV-based combination, which costs $6.9 per patient.

There are an estimated 1.4 million Ugandans currently on anti-retroviral therapy, according to the latest Uganda Population-Based HIV Impact Assessment report.

Kenya, Nigeria and Botswana, which were some of the first African countries to switch to Dolutegravir, have also banned the use of the drug by women of reproductive age.