[Editorial] HIV Drug Shortage

According to WHO, there are some 40 million PLHIVs (Persons Living with HIV) across the world. Of this, 2.31 million live in India. While India has been taking strides in managing HIV case-load, its performance has been waning in the last few years. For instance, several PLHIVs have been protesting against the recent disruptions in HIV drugs’ supply.

What are the drugs used in managing HIV?

There is no cure for HIV infections yet, but the viral load in the patients’ blood can be managed with ART or Anti-Retroviral Therapy.
ART uses a cocktail of drugs to reduce the viral load to undetectable levels. It helps delay the progression of the infection into full-blown AIDS with fatal consequences.
Some of the drugs used in ART include abacavir, lamivudine and dolutegravir.
Of these drugs, dolutegravir is recommended by WHO as the ‘preferred 1^st line treatment’ for its high efficacy and few side effects. NACO (National AIDS Control Organization), the nodal agency for NACP (National AIDS Control Program) under the Health Ministry, recommends its use in treating adults, adolescents and even children (> 6 years old and weighing > 20 kg).

What is the situation?

The Central Medical Services Society, under NACO’s oversight, is responsible for centralized tendering and pooled procurement of HIV products, including ART drugs.
According to the PLHIVs and the bodies concerned with HIV patients and their treatment, there has been a shortage of HIV drugs since March this year. The NACO held that 95% of the PLHIVs haven’t faced any shortage. However, it agrees that the current shortage affects 5% of the 14.2 lakh PLHIVs.
Some 12 states, including Haryana, Uttarakhand, Gujarat, Chandigarh, Himachal Pradesh, Jharkhand, Bihar and Manipur, have been experiencing scarcity of one or other drug, for the past 4-5 months. By July 21^st, even the dispensing centres in the capital region ran out of dolutegravir stocks, triggering protests.
In addition to dolutegravir, used in 1^st, 2^nd and 3^rd line ART regimen, there is also a scarcity of nevirapine syrup which is administered to infants with HIV infection.

Why did this shortage occur?

Such a disruption in supply of life-saving ART drugs and even the current scale of shortage aren’t a new occurrence. Similar situations arose in 2014 and in 2017-18.
In all these cases, the major reason is the failure of the pooled drug procurement mechanism, stemming from the delays in awarding the tenders to the drug suppliers.
NACO typically floats tenders when the centre have 6 months’ worth stock left. The latest tender was floated on December 9^th, 2021, only to be cancelled in January 2022 due to certain problems with the shortlisted company. A tender was floated again in March, but even here the contracts are still being awarded.

Why is it concerning?

Of the 2.31 million PLHIVs in India, 1.4 million depend on NACO’s 680 ART centres for free treatment.
The current shortage would affect some 50,000 PLHIVs– many of them from the lower economic strata.
Usually, PLHIVs receive at least 1 month’s dose from these centre, but now, they are travelling to the centres frequently to avail their doses. This is causing a chilling effect on adherence to the ART regimen as poorer patients, including daily wage laborers, can’t afford such frequent travel.
In some cases, doctors are changing the regimen to overcome this scarcity. However, there are concerns over compliance with WHO guidelines and implications for future treatment options.
In yet other cases, adult PLHIVs are being given multiple doses of pediatric formulations. There is a concern that this could deprive the child patients of their doses in the future.
When centres run out of pediatric doses, children are being given broken/ crushed adult formulations. This is leading to uneven dosing and difficulty for caregivers in getting the children to take the pills as they have an unpleasant taste.
Irregularity in adherence to the prescribed regimen could lead to HIV drug-resistance, according to NACO. This would make drugs, even if administered in future, may not have the desired effect.
This could potentially undo India’s hard won gains against AIDS and derail the global progress towards ending AIDS by 2030.

What is the way ahead?

Since 2004, there has been a decline in AIDS-related deaths, however, the progress has been stalling in the recent years.
This indicates a need to address challenges associated with healthcare system, one of which is the disruptions in medicine supply chain.
Scarcity of health products in health programs’ supply chain isn’t a problem unique to India. Many low– and middle-income countries face similar issues. However, India has the advantage of community monitoring tools that are IT-enabled. These should be used to their full potential.
Political will is required at the ministerial level to take necessary measures to prevent medicine shortages, not only in India’s HIV program, but also in others like TB program.

Conclusion:

The recent drug shortage isn’t a new issue. This is of great concern given the incurable nature of AIDS and its disabling influence over the patients’ lives. If such an issue is ignored, PLHIVs’ right to health is being compromised. Urgent measures to strengthen medicine supply chain is the key to prevent this.