HIV in India — The Challenges Ahead: NEJM.Vol. 356:1197-1201. March 22, 2007

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HIV in India — The Challenges Ahead

Steinbrook, M.D.

The New England Journal of Medicine (NEJM).

Volume 356:1197-1201

March 22, 2007

Number 12

On April 1, 2007, India will launch a new phase of its National AIDS Control Program (NACP). Its goals include reducing the number of new human immunodeficiency virus (HIV) infections — currently, an estimated 98.5 to 99.5% of India's 1.1 billion people remain uninfected — improving treatment, and providing therapy to more people. The 5-year program, known as NACP-III, has a budget of about $2.6 billion, two thirds of which is earmarked for prevention and one sixth for treatment (with the remainder primarily for management), and represents a substantial increase in the attention to and spending on HIV–AIDS. More than 80% of the funds will come from outside India — from the World Bank and other international organizations, governments, and philanthropies. Most of the funding has already been committed.

When I visited India earlier this year, it was evident that the HIV epidemic was only one of the country's many pressing health problems.1 India must decide whether to commit more of the resources that are fueling its rapid economic growth — and the growth of its private health care industry — to improvements in public health and basic health care.2 In 2003, public expenditure on health represented only 1.2% of India's gross domestic product.3 There are 60 physicians per 100,000 population (as compared with 230 in Britain and 256 in the United States). With regard to HIV, challenges include increasing the number of patients receiving treatment, making additional antiretroviral medications available, improving the monitoring of therapy, training physicians and other health care workers, caring for patients with tuberculosis coinfection (see pages 1198–1199), and reducing stigma and discrimination.

Although prevention will account for a smaller percentage of the total NACP resources than at present, it will remain the focus of India's AIDS control strategy. The components of the strategy are similar to those in other South Asian countries and include intensive prevention efforts directed at the high-risk groups of commercial sex workers, injection-drug users, and men who have sex with men, as well as "bridge populations" such as truckers and migrant workers.4 Avahan (Sanskrit for "a call to action"), the India AIDS initiative of the Bill and Melinda Gates Foundation, addresses gaps in India's national response and aims "to prove that prevention can be done at scale," according to Ashok , the program's director. The components of India's strategy also include expanded HIV counseling and testing and treatment for sexually transmitted diseases, broad communication of information on prevention, promotion of condom use, an increase in the proportion of blood donation that is voluntary (since payment for donation attracts high-risk donors), improved access to safe blood, and expansion of programs for preventing mother-to-child transmission.

Each year, about 28 million children are born in India. Skilled health care personnel attend less than half of all births; infant mortality is about 55 per 1000 live births. In 2004, only an estimated 4% of all pregnant women received HIV counseling and testing, and only about 2% of HIV-positive pregnant women received antiretroviral prophylaxis, usually consisting of a single peripartum dose of nevirapine. Moreover, HIV-positive pregnant women may benefit from antepartum combination antiretroviral treatment for their own health. Under NACP-III, more pregnant women should receive monitoring of their CD4 cell counts, antiretroviral treatment, regimens designed to prevent HIV transmission (including combinations of antiretroviral drugs), and other services.

In scaling up treatment, India's domestic pharmaceutical industry has a critical role. A paradox is that Indian companies have become major suppliers of low-cost generic antiretroviral medications to low- and middle-income countries in Africa and elsewhere at a time when there are still major unmet needs for HIV treatment in India. Cipla, a company based in Mumbai, manufactures the largest range of HIV drugs and has the largest market share. Cipla exports 18 times as much antiretroviral medication as it sells domestically, according to Amar Lulla, its joint managing director. Retail drug prices are higher in India than in Africa, in part because of taxes. Eventually, enhanced patent protection for pharmaceuticals in India, which took effect in January 2005, may lead to higher prices. So far, however, no relevant patents have been issued.

Initially, "government activities were not [proceeding] at the speed at which the virus was spreading," according to Suniti , director of Y.R.G. CARE, a nongovernmental treatment, research, and education facility in Chennai. In April 2004, India launched its public-sector antiretroviral treatment program at eight centers. As of January 31, 2007, about 56,500 patients were receiving treatment at 103 centers (see graph); about 62% were men, 32% women, and 6% children. Perhaps 10,000 to 20,000 additional patients were receiving treatment in the private and nongovernmental sectors. The goal is to have 250 public centers open within 5 years, providing free antiretroviral treatment to 300,000 adults and 40,000 children. However, there is no way to know whether this response will be sufficient.

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HIV Treatment in Centers Supported by the National AIDS Control Organization, India, April 2004 through January 2007. Data are from Dr. B.B. Rewari, National AIDS Control Organization, Ministry of Health and Family Welfare, Government of India. Patients with HIV infection in India can receive care in the private sector that is indistinguishable from that provided in leading treatment centers around the world. All the relevant medications and laboratory tests are available. In fact, HIV medications, like other drugs, are sold over the counter. Some doctors and pharmacists, however, provide treatments that make no sense — says she knows of instances in which a patient was told to take ineffective regimens, such as one zidovudine tablet twice a day for 21 days. The provision of ineffective regimens and the development of drug resistance are major concerns.

The national program provides laboratory tests, such as CD4 cell counts, and medications at no charge to the patient. At present, five first-line antiretroviral medications are provided: the nucleoside analogues lamivudine, stavudine, and zidovudine and the nonnucleoside reverse-transcriptase inhibitors efavirenz and nevirapine. More expensive first-line medications (i.e., tenofovir and emtricitabine) are not provided, nor are second-line medications and more expensive laboratory tests, such as measurement of plasma HIV RNA levels. The immediate priorities are to start patients on first-line regimens, to achieve high rates of compliance through supervised therapy and intensive counseling, to build infrastructure, and to ensure that people are not "dying for lack of access to drugs that are available and affordable," according to Sujatha Rao, the director general of India's National AIDS Control Organization.

It seems inevitable that the national program will have to cover additional first-line treatments, second-line treatments, and measurement of plasma HIV RNA levels and that its protocols will eventually reflect the updated recommendations of the World Health Organization.5 Yet the costs of such tests and second-line medications — which, at about $2,000 a year, are about 10 times those of some first-line regimens — remain formidable. According to Rao, a policy of covering additional drugs is "a big responsibility. Once the government says it will provide you with these drugs, it is a commitment forever."

The largest AIDS care center in India is the Government Hospital of Thoracic Medicine, Tambaram Sanatorium, Chennai. Established in 1928 as a 12-bed private tuberculosis sanatorium, it now has extensive outpatient and laboratory facilities as well as 32 inpatient wards, with a total of 776 beds; 8 of the wards are devoted to patients with HIV. Between April 2004 and February 2007, more than 5000 patients began antiretroviral therapy at the hospital. "Every other government and private hospital would just throw the patient out as soon as they found they were HIV-positive," says Soumya Swaminathan, deputy director of the Tuberculosis Research Center in Chennai. "At Tambaram, anyone could walk in at any time. They would be taken care of."

In India, as in much of the world, stigma and discrimination present major barriers to controlling AIDS. In 2005, the HIV–AIDS unit of the Mumbai-based Lawyers Collective, which provides free legal aid, drafted comprehensive antidiscrimination legislation. India's parliament has yet to consider the bill. There are other antidiscrimination efforts, such as a campaign to persuade the courts to overturn, or the parliament to rewrite, Section 377 of the Indian Penal Code, which makes homosexuality illegal and punishable by imprisonment.1

Within the next several months, a more accurate estimate of the number of HIV-infected people in India should be released. Although the estimate is eagerly awaited, its effect, if any, on India's resolve is a matter of conjecture. Regardless of the number, the new phase of the AIDS control program is just beginning, and the challenges remain immense.

Source Information Dr. Steinbrook (rsteinbrook@...

) is a national correspondent for the Journal.

References

Steinbrook R. HIV in India -- a complex epidemic. N Engl J Med 2007;356:1089-1093. [Free Full Text] Luce E. In spite of the gods: the strange rise of modern India. New York: Doubleday, 2007. The 2006 human development report. New York: United Nations Development Programme, 2006. (Accessed February 26, 2007, at http://hdr.undp.org/hdr2006/report.cfm.) Moses S, Blanchard JF, Kang H, et al. AIDS in South Asia: understanding and responding to a heterogenous epidemic. Washington, DC: World Bank, 2006. World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents: towards universal access: recommendations for a public health approach. 2006 Revision. (Accessed February 26, 2007, at http://www.who.int/hiv/pub/guidelines/en/.)

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