Going down memory lane, Dr Gangakhedkar recalled that India took almost 6 years (after the 1st HIV patient was diagnosed) to finally wake up to the realization of the imminent threat of HIV/AIDS, and thus was born the National AIDS Control Programme in 1991-92. Initially it offered treatment only for sexually transmitted infections (STIs) and opportunistic infections (OIs) arising out of HIV. The developed world was, at that time, already providing sequential mono therapy for the disease. 1994 proved to be another landmark year for the West, when prevention of mother to child transmission (PMTCT) became possible with AZT (generic name zidovudine, Retrovir). Also, protease inhibitors led to the evolution of the 3 drugs combination anti retroviral therapy (ART).
FROM DESPONDENCY TO ACTION
The first anti-HIV drug, zidovudine was marketed in India in 1995 but the cost was prohibitively high. It was only in 2000 that generic pharmaceutical companies started manufacturing the drug and prices came down drastically. At that time the feasibility studies for PMTCT, that began in 1998-99, were already over. The government’s PMTCT programme started in 2001—with a private pharmaceutical company CIPLA providing single dose Nevirapine free of cost to as many women and children as possible across the country. Then free ART was rolled out in 2004.
Today, government programme uses the CD4 cell count cut-off <350 cells to put a PLHIV on ART. But in case of women found infected with HIV during pregnancy, ART is started irrespective of CD4 cell count. A simplified once daily fixed dose combination regimen of tenofovir lamivudine efavirenz (TLE) is given for management of HIV in adults and in pregnant women. There is also a 6 monthly immunologic monitoring and targeted plasma viral load testing is used to confirm immunologic failure. The mean CD4 cells count at which a PLHIV presents for ART initiation is > 210, and this is much better than that in many other countries, says Gangakhedkar.
THE NEW WHO GUIDELINE
Recent results of the START, TEMPRANO and HPTN 052 studies, as well as various pre exposure prophylaxis (PrEP) studies have led to new approaches for treatment and prevention. The latest WHO HIV guideline makes available two key recommendations that were developed during the revision process in 2015. Firstly, ART should be initiated in all PLHIV irrespective of their CD4 cell count. Secondly, the use of daily oral PrEP is recommended as a prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches.
CAN INDIA IMPLEMENT THESE RECOMMENDATIONS?
In India, estimated ART coverage among the 21 lakh people living with HIV (PLHIV) is 38%, with close to 8 lakhs PLHIV alive and on ART—768840 on 1st line and 8500 on 2nd line ART. Almost 50% of those who are infected never came in contact with the government programme. If India takes evidence into account and begins to provide ART to the remaining 62% PLHIV, regardless of CD4, then public health outcomes are likely to be enormous – including, but not limited to, quality of life and care, and reducing the rate of new infections as well.
However, despite having a massive infrastructure for provision of free ART related services –516 ART centres, over 976 Link ART centres, 5100 integrated counselling & testing centres, 350 care & support centres—Gangakhedkar lists some of the key challenges that will have to be overcome to adopt the ‘treat all’ approach. These are:
· Strengthening existing ART centres to ensure that the number of PLHIV per healthcare provider is manageably small in order to offer quality services
· Enhancing coverage to key population groups of sex workers, men who have sex with men, and injecting drug users
· Enhancing coverage by ensuring access to testing and treatment services in low prevalence states
· Ensuring quality supply chain management for ART drugs and test kits
· Enhancing timely targeted viral load test in order to offer 2nd line ART to all those who fail 1st line treatment
· Enhancing treatment services to the mobile migrant population
He also cautioned on the need of having enough stock of medicines before embarking on the new strategy. This could take 6 months to1 year from the date India adopts the new guideline, in order to be able to buy additional stocks of drugs. Regarding roll out of daily oral PrEP as a prevention choice, a demonstration study is likely to begin soon among sex workers in Kolkata and Mysore, results of which might spur further action.
Dr Ishwar Gilada, President of AIDS Society of India and Chair of the 8th National conference of AIDS Society of India (ASICON 2015) opening in Mumbai this week (October 30-November 1, 2015) said that, “Test and treat strategy, treatment as prevention (TasP), PrEP, post-exposure prophylaxis (PEP) for the victims of sexual assaults, are some of the evidence-backed approaches where India should not delay to further fortify its programmatic approaches so as to maximize public health outcomes. Achieving the ambitious treatment target of 90-90-90 by 2020 set by the UNAIDS will only be possible by a dedicated and united effort by the government, caregivers, NGOs, pharmaceutical industry, private sector and community.”
In the words of Gangakhedkar—‘In a country that was not used to handling these kind of chronic diseases in the past, we have shown that we can deal with challenges by developing dynamic strategies through progressive and flexible approaches. The past has proved this, and let us hope the future too will hold promises of further controlling HIV infection in India.’
Shobha Shukla, Citizen News Service – CNS