Nongmeikapam Dusmanta, a retired government employee from the water resources department in Manipur, has battled with HIV, or human immunodeficiency virus, for over two decades.
He has seen the evolution of India’s battle against AIDS – acquired immune deficiency syndrome, an HIV-led disease that severely damages the immune system – from a time when there were no free diagnostics or treatment for it, to the setting up of antiretroviral therapy in 2004, and the hurdles that followed it.
But never before, he said, has the struggle been so hard. In Imphal where he lives, the antiretroviral centre at the Regional Institute of Medical Sciences is asking patients to switch to another drug regimen after crucial HIV drugs have run out of stock in government centres.
Dusmanta has refused.
The 67-year-old requires a combination of four drugs: abacavir, lamivudine, ritonavir and lopinavir.
Instead, the antiretroviral centre, which provides free medicines under the government’s National AIDS Control Programme, is giving him three other drugs: tenofovir, lamivudine and dolutegravir, or TLD in short.
“They are asking me to take another medicine without assessing whether it will work on me,” he said. “How can I take it?”
Dusmanta stopped medication for a week this month. Then, worried by a possible rise in viral load, he purchased abacavir, lamivudine, ritonavir and lopinavir from a local chemist. That has meant a monthly expense of Rs 1,400 from his limited pension. “I have no option. I don’t know how long this stockout will continue,” he said.
Haobam Nanao, an HIV-infected person and a health activist, who is himself struggling to get lopinavir and ritonavir drugs, said Dusmanta is not alone. “There are many more in Imphal and not everyone can afford to buy medicines,” he said.
Rani Ngangbam, a staffer at the government-run Regional Institute of Medical Sciences in Imphal, said that at least 20 HIV-infected patients at their antiretroviral centre have had to move from their previous drug regimen to the TLD combination. “This has confused patients. Several have started skipping medicines,” she said.
Expressing helplessness, she added, “What can we do? NACO asked us to change the regimen.” NACO refers to the National AIDS Control Organisation, which works under the Ministry of Health and Family Welfare and is tasked with providing testing kits, medicines and lifelong support to HIV patients.
India has 23.19 lakh HIV-infected people, according to an estimate in the latest NACO report. While Maharashtra, with 3.90 lakh, and Andhra Pradesh, with 3.03 lakh, have the largest populations of infected people, states in the North East have the highest prevalence of HIV.
Since December, NACO has stopped the supply of certain antiretrovirals due to a delay in the procurement process, as reported by Scroll.in on June 28.
On May 30, Dr Anoop Kumar Puri, NACO’s deputy director general, issued a letter to all state project directors asking them to change the regimen of patients “to tide through the crisis situation as an interim arrangement”. Antiretroviral centres have since started switching HIV patients to different drug regimens wherever supply is not available.
The NACO letter said the recommendation was based on consultation with experts. Dr Ishwar Gilada, who is part of a NACO’s advisory group on treatment, said the change in the treatment regimen is temporary.
“It is better to provide some medicine than not provide anything at all,” said Gilada. “It is not going to kill them or put them in hospital, patients should shed that fear.”
Manoj Pardeshi, associated with the National Coalition of People Living with HIV in India and a member of a technical research group that advises NACO, said they are shocked that the treatment regimen was changed as a solution to the shortage of medicines.
“The change in regimen is not ensuring that the viral load reduces,” said Pardeshi. “They are doing it for the sake of doing it so that patients don’t start protesting outside ART centres.”
Puri declined to offer a comment.
Changing a drug regimen
The drug regimen of an HIV-infected person is based on his viral load, or the amount of virus in the body, and the CD4 count, which are the white blood cells that fight an infection. An HIV-positive patient has to take medication every day based on these two parameters.
Dropping the treatment may result in a rise in the amount of virus in the body and the failure of the immune system to fight it leading to death. An ideal outcome of a course of treatment would be a reduction in viral load and an increase in the CD4 count.
If a particular drug does not suit a person or if they are resistant to it, the viral load will continue to mount and CD4 count will drop below 500. That is called treatment failure and is a key indicator to change medication. A patient on first-line drugs will switch to more potent drugs called second-line, or from the second-line to the third-line of medication.
Other reasons for changing the treatment regimen could be toxicity due to a particular drug, heavy side effects or a comorbidity.
In India, despite pressure from states, the Centre is yet to introduce a testing facility, on the lines of the National Tuberculosis Elimination Programme, to check for resistance against a particular antiretroviral in an individual.
Only private clinics and hospitals have this facility in India. Under the government programme, if a patient’s viral load keeps increasing, the entire regimen, comprising two to four drugs, has to be changed since it is not possible to identify which particular drug the patient is resistant to.
Dr Shrikala Acharya, additional project director of the Mumbai District AIDS Control Society, said, “But if a regimen is helping a person get virally suppressed, then it should not be changed.”
“By changing it, we expose them to multiple drugs and pose a risk of resistance to newer drugs,” she explained.
In the current situation, patients who are responding well to medication have been forced to take a new set of medicines due to the shortage.
In Meghalaya, 45 children suffering from HIV in the East Khasi Hills were forced to take the second-line regimen although they were on the first-line of medication, said Barry Leslie Kharmalki, who works with Meghalaya State Network of Positive People.
“They all needed dolutegravir but since there is no supply, the ART [antiretroviral] centre gave them lopinavir and ritonavir,” he said. Kharmalki said both medications are used in second-line treatment. “…Nobody is looking at what harm these drugs can cause on kids.”
Dr Gautam Bhansali, a physician with the privately-run Bombay Hospital, said that under the current circumstances, switching to other antiretrovirals in the same class of drugs is acceptable after checking medical parameters such as renal and liver function, x-ray, serum creatinine levels and tolerance to drug toxicity. “If ART centres are not checking these parameters, then changing the regimen can be harmful for a patient,” he said.
Activists and patients from multiple states, however, told Scroll.in that no such clinical assessment is being carried. This amounts to “playing with the lives of HIV patients,” Kharmalki said.
Patients responding well to first-line drugs have been put on more potent second-line medicines while those already resistant to the first line of mediation have had to revert to it due to the shortage.
“Patients on the second line are already resistant to first-line drugs. If they are given the first line it will not have any effect,” said Kharmalki.
According to him, several antiretroviral centres in Meghalaya did not even inform patients before shifting them to other drug regimens. “People going to government centres are mostly uneducated. They don’t even realise their regimen has been changed,” he said.
On February 7, the Meghalaya State Network of Positive People filed a complaint with state AIDS control society over shortage of Dolutegravir and transition of children to other regimen. In its response on February 11, the latter said the replacement is “temporary” and the same regimen will restart once medicines are available.
Despite the concerns, several patients have had to change their medication and there are conflicting opinions on the effect of such a move.
Dr Gilada, the first to start an AIDS clinic in India in Mumbai’s JJ Hospital, reasoned that NACO’s desperate move to switch to an alternate regimen is aimed at providing respite to patients until a fresh supply of medication is available.
“In the past, when regimens have been temporarily changed, the viral load has not increased,” said Gilada. “If regimen is permanently changed, then there is some impact.”
But Pradeshi, from National Coalition of People Living with HIV in India, said to check whether an alternate regimen is reducing viral load, they will have to wait for a few months to test. “ We are putting patients at risk.”
Jahnabi Goswami, who works with HIV-infected people in Assam, said the government needs to plan in advance to prevent such a situation. “Nothing about how they are handling patients is right,” she said.
Goswami said the network of which she is a part of, plans to check the viral load of patients, whose treatment regimens have been changed, in a few months to understand the outcome.
Runjun Dutta, attached with Médecins Sans Frontières access campaign, said, the government must have a strong reason to change regimen. “And bureaucratic delays that cause supply mismanagement is not a justifiable reason,” said Dutta. “Unfortunately it has become a common excuse for NACO in the last few years.”
Treatment drop out
Activists who work with HIV-infected individuals fear the drug shortages may eventually lead to their worst nightmare: patients dropping out of treatment.
Nalinikanta Rajkumar, president of the Manipur-based Community Network for Empowerment, said he anticipates a high treatment drop-out rate due to the supply problems. “Some patients are buying medicines from their own pockets, and some have stopped taking medicines altogether,” he said. “The government is failing to adhere to the 90:90:90 target.”
The 90:90:90 target has been set by the United Nations Programme on AIDS for countries to control the disease. It means that 90% of those who have HIV will know their status by 2020 and 90% of those diagnosed with HIV will receive antiretroviral therapy, and 90% of those on therapy will have some viral suppression.
Roshan Maisar, associated with the non-profit Saathii that works with the government in the field of HIV across India, said the medication is for life and patients often struggle to take it every day. “They need a lot of counseling for treatment adherence,” said Maisar. “They may drop out if medicines are not available.”
A 44-year-old-patient in Nagpur, who did not want to be identified, said he has reached that point. “I feel I am an experiment for them.”
He has been running around for antiretrovirals since February. He is on a third-line drug regimen comprising Ritonavir, Lopinavir and Dolutegravir.
In February, he purchased medicines for 15 days when the antiretroviral centre had no stock. “These drugs are expensive,” he said. “After my medicines got over, I began visiting different NGOs for help.”
Some non-profits managed to provide him stock through a government centre, but they were paediatric medicines, not adult ones. “Paediatric medicine is 125 mg per dose. I had to take four pills per day to ensure adult dosage,” he said.
By April, even the non-profits could not help him. “I started taking a gap of two to three days between pills to last them longer,” he said.
Earlier this month, the ART centre told him that ritonavir, lopinavir and dolutegravir were not available and that his medication was being changed to a combination of atazanavir and ritonavir.
He said he told the centre that he had taken those drugs in the past but they did not work. “My haemoglobin levels had fallen due to those drugs. There were other patients who were complaining too,” he said. “But the ART centre said they have received instructions from NACO to do this.”
He is back to the old treatment regimen that he knows very well does not work for him. “I am taking it in the hope that it has some effect on my body,” he said.
This is the second part of a series on HIV drug shortages. Read the first part here.
This reporting was supported by a grant from the Thakur Family Foundation. Thakur Family Foundation has not exercised any editorial control over the contents of this article.