In April, after the government hospital in Ahmednagar, Maharashtra, sent her back without her dose of medicines, Mumtaz, 35, who is HIV positive, stopped taking antiretroviral treatment, or ART.
On the sixth day after she stopped her treatment, Mumtaz came down with a fever, stopped eating and started mumbling in a semi-conscious state. Her family then decided to mortgage Mumtaz’s gold earrings to a moneylender to buy her medicines that cost Rs 3,000 and would last two months.
A resident of Sangamner town in Ahmednagar district, Mumtaz has been HIV positive for about seven years. She used to travel every month to the district Civil Hospital at Ahmednagar, two hours away, to pick up medicines at the state-run ART centre there. The bus ride cost her Rs 300, but the medicines were given to her free of cost, and would last her a month.
Over the last two months, however, Mumtaz has had to make five trips to the hospital. “Sometimes they would give medicines for about 10 days,” she said. “Other times, they would say the stocks are out.”
According to the National AIDS Control Organisation, or NACO, each patient’s visit to an ART clinic is scheduled in such a way that they get a month’s supply of medicines a few days before the previous month’s supply runs out. However, for the past three months, the Ahmednagar centre has been rationing medicines by giving each patient an 8-15 days supply only. Despite this rationing, the centre has frequently run out of medicines.
“When the ART centre said that the stocks are out, I stopped going there,” said Mumtaz. “We felt that instead of spending money on going to the centre, we should buy the medicines instead.”
The only working members in her family are her two sons, who take up odd jobs every two to three days a week, and earn about Rs 100-150 a day. The precariousness of the family’s finances puts Mumtaz at risk – if she is unable to buy the medicines and skips her dose for a few days, she would not only get sicker with an increase in viral load, she could even develop resistance.
Maharashtra has among the highest rates of HIV in India. While 1.7 lakh HIV positive patients take basic first-line ART treatment in the state, 4,300 take the more advanced second-line treatment, which patients are put on when first-line treatment fails.
In India, there are 9.4 lakh patients on first-line ART treatment, and 15,567 on second-line treatment.
With funding cuts affecting the supply of anti-HIV drugs across India, Maharashtra has been particularly badly hit. Though the Union Budget increased the allocation to the Department of AIDS Control from Rs 1,397 crore to Rs 1,700 crore earlier this year, the stock-outs continue in the state.
A study conducted by the Centre for Advocacy and Research from April-October with 1,547 patients in five states, including Maharashtra, showed that patients visited ART clinics between two and five times a month and still got no drugs.
According to that study, of the 278 people who received a reduced quantity of medicines even after two visits or more, 31% were from Maharashtra. Similarly, of the people who returned empty-handed from an ART centre, 34% were from Maharashtra. The study also records the cases of patients who visited an ART clinic five times and still got no drugs.
Activists working in Maharashtra say the drug shortages turned severe between March and May this year. The Ahmednagar clinic has seen an acute shortage of the drug combination Zidovudin-Lamavudine. There have been short-term shortages, which last about 10-15 days, of other combinations too, said activists. Last month, Sassoon General Hospital in Pune experienced a stock-out of medicines for second-line treatment.
Officials of the Maharashtra State Aids Control Society said that the Zidovudin-Lamavudine stock for the March-May period arrived on April 29. Until then, it had resorted to stop-gap arrangements, reducing patients’ access of drugs considerably.
For instance, the state Aids control body’s monthly requirement for Zidovudine-Lamivudine tablets is 4.5 lakh. However, in March, NACO provided it with just 60,000 tablets of that drug combination.
“We have been asked to maintain about three months of stock which has not been possible,” said MS Diggikar, additional project director, Maharashtra State Aids Control Society. “Whatever stock came would be consumed in no time as there was a major backlog due to shortage.”
Change in treatment
It is essential for patients on antiretroviral therapy to take their medicines regularly. In fact, patients are even asked to set alarms lest they forget to take their doses at the required hour.
But the stock-outs have forced doctors at the Ahmednagar ART centre to consider a change in the treatment regimen. For instance, if a patient is on Zidovudin-Lamavudine, which is in short supply, he or she was given a Tenofovir-Lamivudine combination that was available.
While some patients resisted this change in the line of treatment and tried to procure their medicines from the private sector, the people who could not afford it gave in. Many patients suffered severe side effects.
Sriram, 35, has been HIV positive for five years – a fact he has concealed from his family. Recently, doctors at the Ahmednagar centre changed his treatment regimen. “My palms got darker after I started on the new drugs,” said Sriram. “I would get scared that someone will know that I have HIV.”
The stock-outs have also cost Sriram his job as a security guard at a bank outside Ahmednagar. Sriram used to visit the ART centre once a month, but over the last two months, he has had to take leave every eight to 10 days for the visits. “My bosses fired me,” he said. “Should I take the medicine, or go to work? I do not know what to do.”
If the stock-outs continue, Sriram cannot afford drugs from the private sector. “If there is no medicine, will I get sick?” he asked. “Won’t people know then that I have HIV?”
Confusion and side-effects
The change in the line of treatment causes a lot of confusion, say doctors. “Many patients [taking treatment] in the public sector have come to us just to understand what changes will take place in their body,” said Dr Sanjay Pujari, an HIV specialist in Pune who practices in the private sector. “I have seen some cases where they go back to the older regimen and that can cause resistance in the bodies.”
There have been cases where doctors have changed the dosage of the drug as per availability.
In an orphanage, Snehalaya, which has 101 children on ART, the acute shortage of drugs created major panic. “When we realised that children were not getting drugs from the ART centre, we sent out people to medical stores to procure them,” said Anil Gawde, head of rehabilitation, Snehalaya. “But many medical stores did not have these drugs either. Finally, after a few days we managed to procure some drugs. A few children missed a dose or two.”
The ART centre changed the treatment for some children owing to the stock-out. Some children had a severe drop in haemoglobin after a change of treatment. This is a known side-effect. Four-year-old Krishna’s haemoglobin levels fell to just 2 grams per decilitre (12 grams per decilitre is considered normal) after the doctors changed his treatment protocol.
Ten-year-old Soham suffered from severe fever after the doctor at the ART centre increased his dosage from 60 mg to 100 mg. He had very high fever and was admitted to hospital for about 25 days in April.
Soham did not want to talk about his hospitalisation. His friend, who overheard the conversation with Gawde, said that during his hospitalisation, Soham felt that he would probably die like his friend Kishore.
Kishore, also HIV positive, died four years ago after months of hospitalisation.
But it’s not just side-effects. The continuing stockouts of anti-HIV medicines are also resulting in lost patients and drug resistance. Lost patients are those patients who give up and stop visiting ART centres after they are repeatedly sent back home without medicines.
Vihaan, a non-profit that works with HIV positive people in some districts of Maharashtra, has collected data that shows many patients miss out on their dates at the ART centres. The data shows that in January 287 people missed their dates while that figure rose to 431 in April.
“The patients who have been missing out on treatment are increasing because of stock-outs,” said Sandhya Bale, the project coordinator of Vihaan in Ahmednagar. “If these patients continue to miss their dates with ART for about six months, then they are termed as patients who are lost to follow-up.”
If a patient is “lost to follow-up”, he or she is likely to develop resistance to first-line treatment.
Drug resistance is another alarming fall-out of irregular ART treatment. In fact, one of the early warning indicators to identify factors known to be associated with HIV drug resistance, as suggested by the World Health Organisation, includes stock-outs of routinely dispensed ART medicines or a thwarted drug supply continuity.
“A virus’s life cycle is six hours. If the drug concentration reduces, the resistant virus starts multiplying,” said Dr Alaka Deshpande, who retired as the head of the ART centre, at JJ Hospital in Mumbai – the first hospital in Maharashtra to start ART treatment.
When the state started providing free ART treatment in 2004-’05, there were plenty of patients who had already developed resistance because of irregular ART treatment. “A lot of patients had taken treatment in the private sector and would sell their property to afford it,” said Dr Deshpande. “Despite that they could not afford it beyond 4-6 months. Such patients developed resistance.”
Continued stock-outs can also result in the resistance to drugs in first-time patients (called primary drug resistance), like in the case of African countries, said Dr Pujari. The viral load of first-time patients is high, and stock-outs at that time can be detrimental, he said.
The effects of these stock-outs will possibly not be known for a long time. Patients in India cannot avail of the viral load test – which measures the sheer volume of the human immunodeficiency virus in the body – unless they fall sick, or have lowered immunity levels. WHO now recommends that a HIV positive patient undergoes a viral load test every six months.
Uncertainty over stocks
Hospitals facing stock-outs say they try hard to circumvent shortages, and say that they send repeated reminders to the Maharashtra State Aids Control Society to replenish stocks. The Maharashtra body blames NACO for not providing them with stocks.
Dr RS Gupta, joint commissioner, NACO, said that the states earlier had been inefficient and had disposed of huge quantities of expired ART medicines. "We got into a lot of audit problems, both in those states and centrally,” said Dr Gupta. “To avoid wastage of government money we are keeping strict watch of medicines."
As a result, added Dr Gupta, NACO was procuring lesser quantities of medicines – only three months extra stock in a year as compared to eight months extra stock a year that they procured earlier.
At the ground level, chaos continues.
The pharmacist at the Ahmednagar hospital said he had written to the Maharashtra State Aids Control Society and NACO about eight or nine times in the past months informing them of the stock-outs. “This is the first time we had such an acute stock out,” he said. “Usually the stock would at least arrive a couple of days after we asked for it.”
The initiative of a medical officer at the Ahmednagar hospital provided a respite for patients. One of his friends, who is a medical officer at Malegaon, told him that he had very few patients and that the Malegaon centre had excess stock.
“I immediately wrote to MSACS seeking permission to relocate the stock to Ahmednagar,” said the doctor. “We got permission and now we have stock for two months. Otherwise the stock-out would have continued.”
He added carefully, “We do not know when the next stock will arrive.”
Note: The names of some patients have been changed to maintain their privacy.
This is the first story in a three-part series on HIV drugs.