Lack of life-saving HIV drug, Septrin, puts patients at risk, State cites supply hitches

For many of us, Covid-19 is that invisible enemy that is scary. But for people with preexisting conditions, like those living with HIV/Aids, the coronavirus can be a daunting task, because the consequences of infection are dire.

What makes the situation even worse for people living with HIV/Aids (PLHIV), is that the immunity-boosting drug, Septrin, is out of stock in health facilities, and has been so for some time now.

Septrin is a vital antibiotic for PLHIV with a low CD4 count. The crucial drug is taken daily by many living with HIV/Aids to fight against opportunistic infections. Government health facilities provide the drug for free together with other antiretroviral drugs for those with a prescription, but for some months now, due to what the Health Ministry terms as, ‘procurement delays and funding glitches’, patients have been met with empty shelves.

The drug is available in private clinics and pharmacies at a cost of between Sh60 and 100 per tablet, which brings the monthly cost to between Sh1800-Sh3,000 per user, a cost that is out of reach for many, especially now during Covid-19 times when incomes have dwindled or cut altogether.

Exposed child

One of those affected is Ms. Elizabeth Atieno and her seven-year-old daughter, Awino. The Kisumu town resident has been living with HIV for 20 years now, all was well because they could easily access the drugs they needed from a nearby health facility. But, for the last four months getting Septrin which they both need for survival has not been possible.

Her daughter was prescribed Cotrimoxazole most commonly referred to as Septrin at six weeks and has been getting it for free at Kisumu County Referral Hospital. That was until April this year when Ms. Atieno was told that the drug was out of stock.

“They keep telling me that the drug will be available in the coming weeks, but it has become a song,” she says.

For three months, Ms. Atieno struggled to buy Septrin from the local pharmacy, in which she had to spend Sh120 daily, but after she fell sick, her income from her grocery business at the local market dried, and they had to make do without the drugs.

Her daughter’s immunity is now weak and she has been fighting one opportunistic infection after another. One time it was flu, then fever, and another time iarrhea.

“Anything that comes her way will bring her down, her immunity is very weak and I am afraid if nothing is done, even flu will kill my daughter and I am also at risk,” says the mother of six.

She continues: “One day in September, I knew she was dying, she was coughing blood and it would not stop. I am a worried mother,” Ms. Atieno says

Mother to child transmissions

Septrin is a combination of two antimicrobial drugs that are active against a range of bacterial, fungal, and parasitic infections; prophylactic antimicrobials are taken to prevent infection. It decreases morbidity (illness) and mortality among HIV-infected individuals primarily by reducing the rates of malaria, pneumonia, iarrhea, and severe bacterial infections.

The World Health Organisation guidelines recommend that, in resource-limited countries, HIV-infected patients whose CD4 count is less than 350 cells should take Septrin.

The drug is given routinely to all children born to HIV-positive mothers.

Should the baby turn positive, then they have to continue taking it throughout breastfeeding time and later in life.

Awino’s body is covered in rashes, a result of withdrawal signs of Septrin. “For some of us without money, our chances of surviving are minimal as we depend on the drug to look healthy. Now, it is very easy for someone to notice that my daughter is HIV positive because of the frequent attacks,” she says.

Globally, Kenya has one of the largest HIV epidemics with about 1.5 million people infected. Of these, about 1.4 million are adults while 106, 807 are children aged 0-14 years according to the Kenya HIV Estimates 2020.

The World Health Organization (WHO) recommends that all HIV-exposed infants be started on co-trimoxazole prophylaxis (Septrin) at four to six weeks of age, in order to provide adequate prevention against early opportunistic infections. This is particularly critical for HIV-infected infants.

Danger if dying

Dr. Patrick Oyaro, an HIV expert, says that Septrin is very crucial in preventing and treating opportunistic infection among the HIV positive population.

“It really pains me when a mother calls me that there is no drug that would help her stay alive. Without the drug, there are high chances that we could be losing some of our patients because of the diseases and with Covid-19, it would be very difficult to collect the data,” Dr. Oyaro says.

Another HIV-positive person who fears for her life is Zipporah Gachagua. For the last 17 years, Zipporah a resident of Nairobi has depended on ARVs alongside Septrin for her survival. The woman who was born HIV positive has not been able to access the critical drug as usual for some months now.

“I can’t take other ARVs without Septrin, it boosts my immunity and helps me fight other diseases including sexually transmitted diseases, herpes zoster, and even the frequent attacks like malaria, cough, and flu,” Ms. Gachagua says.

The interviewees are a representation of millions of Kenyans who are infected with the HIV virus and have gone for eight months without the drug. This has exposed them to opportunistic infections and they are at higher risk of contracting Covid-19 and dying.

The eight-month wait has wind-swept the gains that the country has made in HIV and is setting back efforts to end Aids by 2030. This could affect the prevention of mother to child transmission, since babies who are born to HIV positive mothers and are therefore at a higher risk of infection, missed out on the drug in public facilities.

Dr. Oyaro told the Healthy Nation that the drug is highly effective in reducing morbidity and mortality among HIV-infected people. All infants exposed to HIV should be started on co-trimoxazole prophylaxis during the first four to six weeks of life, as recommended by the World Health Organisation (WHO).

He says the patients who cannot afford the drug for themselves or for their children are suffering psychologically due to fear of imminent death from opportunistic infections.

“The drug is very critical, particularly for HIV-infected infants. Providing the drug protects against serious, often fatal, opportunistic infections and leads to improvement in the quality of life of HIV-infected infants while reducing the burden of care on health-care systems and caregivers. Without the drug, more are going without it, more deaths could be recorded,” the expert told the Healthy Nation.

Government response

A report by the Ministry of Health done in September this year attributed the stock-out of Septrin to the reduction of funding from the United States President’s Emergency Plan for AIDS Relief (PEPFAR), which was supporting the procurement of the drug. PEPFAR is the largest funder of Kenya's HIV response.

However, according to a letter seen by the Healthy Nation, written by the Permanent Secretary, Susan Mochache in the same month, to the Kenya Medical Supplies Agency (KEMSA), the drug supplier had not procured the drug or delivered any batch as promised.

The procurement that was to be delivered in January under the Universal Health Coverage Program funding, had not been dispatched eight months down the line yet the patients are suffering.

"The Ministry of Health authorised the procurement of Septrin tablets to Kemsa through a letter Ref: MOH/ADM/1/2/16 VOL. 1 (134) dated January 24, under the UHC program funding worth Sh1.2billion, however, through a meeting with the ministry officials, Kemsa and the supplier, the Ministry reliably learnt that the supplier is yet to make any delivery despite the last day of the delivery being end July," says the letter.

According to the contract, the initial 30 per cent of the delivery was to be made by the end of June while the remaining in July, but this was not honoured.

"Public health facilities ran out of stock for the medicine by the end of April, worsening the stock out of the situation to a crisis over the months. Many patients have been forced to get the medicine through out of pocket expenses with those unable to afford going without it and consequently putting their health at great risk," says the letter that was written on September 1.

Ms. Mochache suggested that the agency takes cognition of the local manufacturers to alleviate the suffering the soonest time possible.

"The Ministry will no longer sit back and continue to witness the crisis bite and the patient continue to suffer," the letter further states.

However, with the warning tone of the letter, the Healthy Nation has learnt that no delivery has been made to date in most public facilities even as the government insists that they have since procured the drug.

It is not clear how long the children will have to wait but it might take time. The third line drug is mostly for those who have drug resistance on the first and second line of treatment.

In Kenya, 78 children are on the third line, in Homabay County there are 17. Of the 17 in Homabay, eight children are waiting for the drugs to be available.

Some of the third line drugs include Darunavir/ritonavir, Atazanavir/ritonavir, Lopinavir/ritonavir, Etravirine, and Raltegravir. When the drugs are not available in the country the children are placed on a waiting list.

"You might think that the number of children that need the drugs is few but even losing one child because there are no drugs is very painful. Let the government avail the drugs to the patients," said an officer in Homabay who sought anonymity.

"I have lost count of the patients I have had to send money from my pocket to buy the drug. If they cannot even afford to buy food, are they going to prioritise medication? We are failing our patients," the officer says.

Alternatives from Nascop

Dr. Catherine Ngugi, the head of the National AIDS and STIs Control Programme (Nascop) attribute the initial shortage of Cotrimoxazole to funding gaps. This was caused by the withdrawal of US PEPFAR support for the purchase of Cotrimoxazole for People Living with HIV (PLHIV).

"Bridging the gap on donor dependency the current monthly average consumption of Cotrimoxazole is approximately 450,000 packs (of 100s). The government will each year buy Cotrimoxazole worth 1.2 billion or more to ensure that the country does not run out of this essential drug again," says Dr. Ngugi.

Local Manufacturing Cotrimoxazole has in the past been outsourced from international manufacturers. In line with the GOK policy for the Big 4 agenda, local manufacturers have been considered for the supply of cotrimoxazole.

The restricted tender was awarded to a local manufacturer, Universal Corporation Limited to supply 1.3 million packs of Cotrimoxazole at Sh200 in batches of 100,000 packs every week from November 16.

"The award to a local manufacturer gives long-lasting solutions for our country's disease burden. The Ministry regrets the disruption and is doing everything possible to ensure that we do not have another stock out," Dr. Ngugi says

She acknowledged that children and young people are a cause for concern in the fight against HIV in the country.

"Children and adolescents are more affected due to unfavourable treatment formulations which are intolerable to them meaning that some children medications are bitter to swallow and some are difficult for caregivers to administer," she says

Dr. Ngugi says that in order to win the war against HIV and reduce its effects on the Kenyan population and achieve the country's vision of a Kenya free of new HIV infections, stigma and AIDS-related deaths must be bridged not only in service provision but also in systems that enable us to deliver more efficiently.

To solve the shortage problem, Dr. Ngugi says that the children on treatment are being moved to the drug Dolutegravir (DTG) which is superior.

"Our laboratories are well equipped for the identification of those failing their drugs for timely Drug Resistance Testing. We are also identifying systemic barriers and bureaucratic processes that delay approval for DRT testing," Dr. Ngugi said.

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