Is HIV drug resistance testing the need of the hour?

Falaknaaz Syed - Mumbai

Even as around five million people in the country are estimated to be HIV-infected and with experts citing HIV as an epidemic which can explode at any time, HIV Drug Resistance Testing, one of the few crucial tests which helps a specialist choose an appropriate therapy for HIV patients, is not commercially available in India.

The test requires sophisticated equipment like genetic analyser, thermal cyclers, skilled staff and appropriate infrastructure to get reliable results. Also the technology being borrowed from abroad makes the cost of the test to around Rs 20,000-25,000, which is unaffordable to patients as the majority of the patients afflicted with HIV belong to the lower strata of the society.

Presently, the test is available at only two institutes in India — Pune-based National Institute of Virology which uses it as a research tool and SRL Ranbaxy, Mumbai.

A leading Mumbai-based laboratory Metropolis Health Services Pvt Ltd, having a chain of corporate clinical diagnostic centres across India and UAE, will introduce the US-FDA approved HIV Drug Resistance test in India by this month, making it the only laboratory to offer the test on commercial basis.

Explaining the need of this test, Dr Nilesh Shah, VP, operations, Metropolis Health Services (India) Pvt Ltd, said, ‘‘HIV virus has various subtypes and is constantly mutating under several conditions. A mutated HIV virus develops resistance to several drugs. If drugs are inappropriately selected, they fail to produce expected results. For prolonged suppression of viral load, it is necessary to have a targeted therapy; this is where an HIV drug resistance test is much needed as it determines the anti-retroviral drugs, which will be more or less effective against a patient’s specific HIV virus. So far, laboratories indirectly conclude it through HIV viral load testing, which is not considered an accurate tool by many experts.’’

‘‘This is a reliable test and will be available across the country after a series of trial runs. HIV-1 drug resistance testing ensures prolonged viral suppression and controlled HIV-1 care cost,’’ he added.

The test involves reading of the genetic code of the virus to detect mutations or differences from the normal HIV virus. At Metropolis, a software library based on the pattern of mutations and a set of rules put together has been developed by a panel of experts. Based on these two things, a drug resistance/susceptibility pattern is derived by them.

Dr Om Shrivastav, infectious disease specialist at Asian Heart Institute and Sir H N Hospital opined that the test should be commercially available, as patients from the upper class can afford it. The test will enable a targeted therapy, he added.

However, not all agree on commercialisation of HIV Drug Resistance Testing. SRL Ranbaxy which has been offering the test since the past eight years has not commercialised it so far. Dr Sumedha Sahni, director, Central Clinical Lab operations for SRL Ranbaxy said, ‘‘At a time, when the first line of treatment for HIV is not affordable to the patients and when the government cannot keep its promise of providing free treatment to 25,000 HIV patients, it can not screen people and pregnant women for HIV, considering the fact that there are only 40 accredited laboratories in the country and in 20-30 per cent cases ELISA results have been proved wrong, I don’t think commercialising HIV Drug resistant testing is pertinent at this juncture. ’’

falak@expresshealthcaremgmt.com