Outcry as people living with HIV receive expired ARVs amid acute drug shortages

A section of expired ARVs dispensed to people living with HIV. [Benard Orwongo, Standard]

She took Antiretroviral (ARV), but quickly noticed they had expired.

This was after checking the bottle and noticing that the life-saving drugs had expired.

Dorothy Onyango, Founder and Chief Executive Officer of Women Fighting AIDS in Kenya (WOFAK), quickly returned the medicine to a clinic where she had collected it, in Nairobi.

But at the clinic, she was reassured that the ARVs were still safe for use.

But Onyango was not convinced. She said no and demanded in-date ones.

"I said no to expired drugs," she recalls.

According to her, though expired drugs have at least three months of shelf life, past their expiry date, the thought of taking expired drugs is unsettling.

"When drugs expire, there is always three months allowance, which is not bad. But in your mind, taking expired drugs sounds bad. So, I returned them," says the advocate, also the founding chairperson of the National Empowerment Network of People Living with HIV/AIDS in Kenya (NEPHAK)

She has returned at least 45 tablets.

After insisting on a replacement, she was only given a refill of 15 in-date drugs.

She demanded more, but was told there was a stockout, and the little available was to be shared among all individuals living with HIV.

The shortage, she says, was not only limited to Nairobi but across the country.

"They gave me 15 because they did not have enough," she adds.

After completing the dosage, she went back to her clinic and was given a three-month refill.

Onyango, an HIV advocate since the 1990s, has been taking the ARVs Tenofovir Alafenamide Lamivudine (TAFLD) for two years now.

The TAFLD is a type of ARV administered to individuals aged 60 years and above to protect their kidneys and bones.

Since she began using the regimen, Onyango testifies that she has had no kidney or bone problems.

This is after undergoing kidney screening and having her bones checked.

"I demanded the drugs because I knew it was a better regimen for me, especially as an older person," adds Onyango.

The shortage, she says, has persisted since June.

People living with HIV have since raised concerns.

Before patients were switched to the regimen, they first underwent tests to determine whether they qualified for it.

"It took a long time to qualify people for the medicine. By the time they started dispensing it, they were giving everyone only 15 tablets because supplies were limited. But by then, some of the medicine had already expired," Onyango explains to The Standard.

She adds, "For me, from the beginning of May, I was given expired drugs. When I went back to the clinic, they told me it was okay, but I said no."

The advocate is now calling on NASCOP to urgently address the shortage and ensure patients receive adequate supplies of in-date medication.

Contacted, the head of NASCOP, Dr Andrew Mulwa, said there is no stock out of TAFLD.

Mulwa maintained that it is a molecule that has been introduced to the elderly and patients with kidney disease since August last year.

However, he admitted to a delay in the delivery of some stocks as a precautionary measure.

Because of this, he said NASCOP has slowed down transitioning new clients.

"We have no stock out of TAFLD per se.  It's a molecule we are introducing to the elderly and patients with kidney disease from August last year," said Mulwa.

But in a quick response, NEPHAK executive director Nelson Otwoma said a delay in delivery is a stockout.

"If there is a delay in delivery, what are those in the molecule to do? Wait? Share? Go back to TLD? And when is the delay ending?" posed Otwoma.

Otwoma said it is worrying and it means those ageing with HIV, 60 years and above, and those with bone and kidney problems do not have medicine.

With this, the individuals may be forced to go back to TLD, a move that risks health challenges, especially the development of chronic kidney disease.

Otwoma further questioned that because there are fewer doses, if elderly people living with HIV are given pills for a shorter period, lasting only one or two weeks, or one month.

With short refills, he said the elderly will be going to the hospital weekly or monthly instead of the preferred three to six months.

Additionally, he said it is worrying that no new people are being transitioned to TAFLD during this time, even if they have kidney/bone disease.

Further, Otwoma explained that TAF is a highly effective, modern ARV drug.

The drug is a safer, newer version of the older drug Tenofovir (TDF).

It protects the kidneys and bones much better.

It is a main ingredient in multi-drug combination pills like Biktarvy.TLD.

TDF is the most widely used single-pill daily regimen recommended by the World Health Organisation (WHO).

In Kenya and much of Africa, people living with HIV use TLD, Lamivudine, or Dolutegravir, which is the preferred first-line ARV in Kenya.

"This ARV is really effective and easy to use because it is just one pill taken daily," says Otwoma.

Most adult Kenyans who have HIV are in this line.

Data by the National Syndemic Disease Control Council (NSDCC) shows that about 1.4 million people living with HIV are on treatment.

According to Otwoma, the treatment has some side effects, especially when used for a long time, as it leads to chronic kidney disease.

"So, the WHO advised that people above 60 years and those with kidney problems should not be given TLD but should be given TAF LD," explains Otwoma.

Kenya already adopted TAFLD in 2024 and the new guidelines state so.

"But now we don't have the medicine," maintained Otwoma.

Lack of supply of the ARV, according to Otwoma, simply means those ageing with HIV, who are 60 years and above and those with kidney problems do not have medicine

Some, he said, may be forced to go back to TLD and this will come with health challenges like chronic kidney disease.

In Kenya, TAF-LD is prescribed as an alternative first-line antiretroviral (ARV) regimen specifically optimised for individuals who cannot tolerate standard Tenofovir Disoproxil Fumarate (TDF)-based regimens.

It is a single-tablet, fixed-dose combination.

NASCOP integrated TAF into the Kenya HIV Prevention and Treatment Guidelines to ensure safer, highly efficacious treatment options for specific sub-populations of people living with HIV who face severe risks from traditional TDF-based drugs, including PLHIV with Impaired Renal Function and in whom TDF could cause severe kidney injury; PLHIV with weak bones or Bone Disease.

"TAF has a significantly more favourable bone safety profile than TDF, reducing the risk of a decline in bone mineral density (BMD) and Older PLHIV (aged 60 and above) to minimise the risks of drug toxicity and manage age-related comorbidities.

According to NEPHAK, many batches of TAFLD expired in May.

This is because Kenya imports short shelf life ARVs, because they are cheap as compared to those with long shelf life.

"Many people have brought them (expired ARVs) to NEPHAK. We have notified NASCOP," said Otwoma.

Further, NEPHAK shared with The Standard samples of the expired drugs.

On one of the bottles indicate the ARVS expired in May, 2026.

In May this year, NASCOP, through its head, Dr Mulwa, alerted counties and NEPHAK on the interruption of supply on May 28, 2026.

In the letter that The Standard has a copy of, NASCOP acknowledged a shortage of Tenofovir Alafenamide/Lamivydine/Delutegravir (TAFLD), because of supply chain disruptions,

Mulwa assured of the supply by June, but in July, the medicine is not yet in the country.

To prevent total stock out, BSCIP noted to have halted new initiation of TAFLD, suspended transition to TAFLD, restricted dispensing doses and interfacility redistribution of available stocks.

“In cases where patients meet the TAFLD use criteria, specifically those with a confirmed diagnosis of oesophageal cancer and impaired kidney function (creatinine clearance 30 to 60 ml.mm), clinciaisna re advised to consult the regional technical working group or NASCOP for further guidance before proceeding.

Meanwhile, NASCOp noted it was fast-tracking procurement modalities to restore the normal supply chain within the shortest time possible.

Otwoma added that short shelf life means the government bring medicines that expire in less than 2 years, or ones that expire within a year, or 12 months.

"Medicines can last long, some even for six years, but they are expensive," said Otwoma.

"NEPHAK is demanding uninterrupted care and we want the elderly and those with bone/kidney health problems to be transitioned to TAF immediately," said Otwoma.

In an interview with The Standard, Otwoma imagined that people who have been TAF LD must never be asked to go back to TLD because this would compromise quality care.

"The Ministry of Health promised to give better, safer, well-tolerated ARVs to those who need them. MOH must not let elderly PLHIV down," said the official.

Prof Matilu Mwau, who has been in HIV research spaces, said such medicine might not be so effective.

"In a sense, expired drugs are harmful. Not that they will get poisoned by the drugs. No. But that the drugs might not be so effective," said Prof Mwau.

Expired ARVs, he said, will not suppress HIV as well as they should.

HIV resistance among people taking the medication, he said, is likely to emerge.

"Lack of effectiveness means treatment could fail and the users may start seeing evidence such as opportunistic infections," added the researcher.