Some HIV drugs cause mental disorder among women, new study says

Patients on some HIV drugs have developed serious mental illnesses, including dementia, with women the most affected.

Medical experts are now recommending patients using these medicines be immediately put on safer regimens.

A study among 345 patients attending routine HIV treatment at Kenyatta National Hospital (KNH) found that 84 per cent suffer mental disorders.

Researchers from KNH, University of Nairobi, Massachusetts General Hospital, Harvard Medical School, US, and the Christian Health Association of Kenya say some of the disorders are linked to certain HIV drugs.

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“Patients on the regimen AZT/3TC/EFV were 3.7 times more likely to have HIV-associated neurocognitive disorders (HAND) compared to other treatment regimens,” says the study appearing in Neurology Research International Journal.

The researchers found the risk of HAND in women is 117 per cent higher than in men, says the study published in October. AZT/3TC/EFV is a combination of the drugs Lamividine, Zidovudin and Efavirenz, and a recommended first line treatment for people aged over three years in Kenya.

An earlier study by, among others, Kenya’s top psychiatrist Prof David Ndetei of the University of Nairobi and carried out at Muhimbili National Hospital, Tanzania, had similarly found high incidence of mental disorders among patients on ARVs.

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Among 351 patients on ARVs at Muhimbili hospital, 68 per cent had mental health disorders, including dementia, which were largely linked to regimes containing the drug Efavirenz.

In both studies the experts recommend provision of less neurotoxic medicines in the region, “particularly for women.”

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The US President’s Emergency Plan for AIDS Relief (Pepfar), supporting 969,767 Kenyans on ARV treatment, recently showed concerns over the country’s ‘slow’ change to safer regimens.

Regular checkups

Pepfar in its 2018 financing plan for Kenya had recommended the quick changeover to regimens containing the less toxic drug called Dolutegravir (DTG) by 2019.

However, this seems not to be moving fast enough, with an action memo from the US State Department in August making adoption of a DTG regimen one of several minimums Kenya must meet by next October or risk further aid cut.

“Introduction of the fixed dose combination of Tenofovir, Lamivudine and Dolutegravir (TLD) is a minimum requirement of the Kenya Country Operating Plan 2019,” warned the memo. Dolutegravir is associated with drug manufacturer, ViiV Healthcare US.

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Medical experts are also concerned about the safety of the daily HIV prevention pill called pre-exposure prophylaxis (PrEP) currently being used by about 56,000 healthy Kenyans.

Several generics

The PrEP was introduced by the government in 2017 for people at highest risk of HIV infection, including sex workers, discordant couples and adolescent girls.

A study published in the Open Forum Infectious Diseases Journal in October by Kemri and several foreign universities confirmed PrEP to reduce bone density among users. Low bone density can lead to fractures or osteoporosis.

The study carried out among 4,758 discordant couples in Kenya and Uganda recommended more investigation, especially among young users whose bones are not fully developed.

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Manufacturers of PrEP brand name Truvada but with several generics in Kenya, indicate it has serious side effects, including kidney impairment, bone loss and liver problems.

They, for example, recommend users be screened for kidney function before being put on the pill and regular checkups thereafter.

“Renal function testing is recommended (but not required) by Kenyan guidelines but due to unavailability of the relevant tests, clients were often initiated on PrEP without such testing,” said Dr Elizabeth Irungu of Kemri.

Dr Irungu was making a presentation at the 10th International Aids Society Conference in Mexico in July.

We asked the Pharmacy and Poisons Board whether such shortcuts are healthy for Kenyans.

“We advise healthcare professionals and the public to report to us any adverse events they may experience while on this medication,” responded the board in an email.

The board then directed us to the National AIDs and STI Control Programme (NASCOP), which it said is responsible for the implementation of the PrEP programme. Two months later NASCOP has not responded to our emails.

Currently, there are 56,000 healthy PrEP users in Kenya, at an estimated cost of Sh500 million annually. The original PrEP marketed under the brand name Truvada is manufactured by Gilead Sciences and most of the generic versions by Mylan NV, both of the US.

Last year, Gilead Sciences made Sh300 billion from Truvada and overall about Sh1.4 trillion from its HIV franchise.

Mylan, mainly a generic manufacturer with headquarters in Pennsylvania, US, reported total revenues of about Sh1.1 trillion in 2018.

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HIVKenyatta National HospitalHIV treatmentPrep