Care without drugs
OFFICIAL estimates of HIV infections in India indicate a figure slightly less than four million. This is equivalent to an adult HIV prevalence of less than one per cent in the general population. By all parameters, India is a low prevalence country, especially when compared to several countries in sub-Saharan Africa with double-digit prevalence rates, some over 20%. While prevention continues to be the top priority of the government, care of those already infected is also an integral part of the National AIDS Control Programme.
Since the detection of the first AIDS case in 1986, a number of HIV infected people have developed AIDS and died in India. Estimates of deaths due to AIDS in India vary, but UNAIDS recently estimated annual HIV deaths to be around 300,000. For roughly two-thirds of those who died, the cause of death was TB. Though TB is completely curable, it becomes fatal for HIV infected persons due to their low immunity levels. Yet, timely treatment of opportunistic infections like TB can prolong the life of HIV infected persons significantly and improve their quality of life.
The first major breakthrough in the treatment of AIDS came in 1996, when a new class of drugs, called anti-retrovirals (ARVs), became available for the treatment of HIV infection. When ARVs are used in a combination (usually three), remarkable reductions in the viral load have been seen with tremendous improvements in the quality of life, enabling AIDS patients to lead a near-normal life. The advent of such highly active antiretroviral therapy (HAART) has sharply brought down AIDS related mortality levels in many developed countries and even in a developing country like Brazil. Due to their very high cost (yearly around $ 10,000 in the US), the ARVs had remained beyond the reach of most infected people in poorer countries until very recently. But the development of generic versions of many ARVs at a fraction of the original prices, especially in India (yearly around $ 350), has given rise to a renewed hope to HIV infected people in India.
ARVs have proved to be a mixed blessing for AIDS patients. Many of them have severe toxicity and induce strong side effects, sometimes resulting in the patients discontinuing HAART. But any deviation from strict adherence to the treatment regimen may result in the development of resistance and the infection tends to rebound with increased virulence. In many cases, the basic triple therapy needs the inclusion of a protease inhibitor, a very expensive ARV. Further, the science of HAART has been evolving rapidly, with the availability and publication of more and more case histories of patients being treated with ARVs. For example, a few years ago, starting HAART as soon as a person was detected to be HIV infected was considered the best course (‘early HAART’). But, delaying HAART as much as possible is now increasingly being adopted by physicians (‘late HAART’).
In light of these latest findings, what are the implications for India? With the exceptions of preventing mother to child transmission of HIV and as post-exposure prophylaxis for health care professionals, ARVs are not part of the Indian government’s National AIDS Control Programme. This is understandable, given the high cost of even the generic versions of the ARVs to be used in India for a programme of such magnitude. Moreover, a HAART programme would require specialised testing facilities and highly trained physicians. However, the Indian government has facilitated a reduction in the prices of these drugs by sharply lowering various duties. Consequently, in many cities of India, an increasing number of trained physicians in the private sector have been administering HAART to an increasing number of AIDS patients who can afford them. By all accounts they constitute a small proportion of the total number of people needing such treatment. As a result the question of including HAART in the National AIDS Control Programme on a cost-free basis has been raised sometimes.
Even a rough calculation would show that including HAART in the national programme on cost-free basis would require several times the current outlays of the programme. Further, administering HAART in all parts of India with infrastructural and personnel requirements would be a stupendous task. There is evidence from some other countries to show that improper administration of HAART can result in the emergence of drug resistant strains of HIV in the community. Above all, there is the question: In a country where thousands of people still die of easily preventable and treatable diseases (at low cost) like diarrhoea and respiratory infections, can we divert scarce resources to treat a comparatively small number of AIDS patients with very expensive drugs, whose long-term effects on the disease or on the patient are not well established?
Due to its high cost, the need for highly trained physicians and advanced testing facilities, HAART belongs in the category of tertiary health care. India has sometimes been criticised for spending too high a proportion of its scarce resources on tertiary care, benefiting only a relatively small number of people, instead of focusing on primary health care that reduces the mortality and morbidity for a very large number of people at a very low per capita cost to the government. What, then, is the alternative?
The Departments of Commerce, and Chemicals and Petrochemicals of the Indian government are actively promoting the exports of generic versions of ARVs to other developing countries, especially in sub-Saharan Africa and Latin America, without violating the World Trade Organisation (WTO) agreement on trade related intellectual property rights (TRIPS). As the volumes of these exports grow, coupled with the tax concessions given by the government, the domestic price of ARVs are likely to fall further, making them affordable to a larger number of people. Only when the price of ARVs fall to a level comparable to other drugs dispensed free of cost by the government, would it be feasible for the government to consider their inclusion in the national programme. At the same time, the implications of the coming into force of the product patent regime (different from the current process patent regime) from January 2005 on the domestic manufacture of generic versions of ARVs need careful examination.
Moving away from ARVs, there is a lot of scope for improving the access to the treatment of opportunistic infections like TB. Sometimes there are reports of such treatment being denied to AIDS patients in both private and public hospitals, though the government’s guidelines on this are very clear. The Tamil Nadu government’s TB sanatorium at Tambaram (near Chennai) treats around 500 AIDS patients (as inpatients) at any given time, the largest number in a single hospital in India. Its high quality of care and humane approach attract AIDS patients from all over India who may have been denied treatment elsewhere. Yet, this hospital does not provide ARVs; it provides good quality treatment for several opportunistic infections, especially TB, and many patients get well enough to return home to their normal life. This has now become a training centre for government physicians and more such units have become operational in the district hospitals of Tamil Nadu.
If this model is adopted in other parts of India, especially in the high HIV prevalence states like Andhra Pradesh, Karnataka, Maharashtra and Manipur, the morbidity and mortality of AIDS patients may be reduced considerably. This will also give AIDS patients a greater chance to access newer and cheaper drugs, as and when they become available.
To sum up, while export promotion and tax concessions are steadily bringing down the domestic price of ARVs, it may not yet be feasible to provide them free of cost as a part of the government’s National AIDS Control Programme. On the other hand, the Tamil Nadu experience has shown that there is ample scope for providing high quality care for opportunistic infections like TB free of cost. This itself can go a long way in improving the quality of life of AIDS patients in India and in reducing AIDS related mortality. At the same time, we must keep in sight the fact that HIV prevention programmes must be implemented vigorously because over 99% of Indians can be protected at a very low cost. Once again, Tamil Nadu, has shown the way in cost-effective prevention programmes and humane care for AIDS patients.
* The views expressed here are of the author’s and do not constitute an official statement of the government.