The introduction of generic antiretroviral therapy in India in the year 2000 has had a significant impact on the natural history of HIV infection in Southern India, as the death due to HIV disease has decreased in a considerable rate within the time, according to a study conducted at Chennai.

The death rates decreased from 25 to 5 deaths per 100 person years between 1997 and 2003, earmarking the introduction of generic HAART, according to the study conducted by the experts from YRG Centre for AIDS Research and Education (YRG CARE), Voluntary Health Services, Chennai and Division of Infectious Disease, Miriam Hospital, Brown University, Providence, Rhode Island. The study reveals that the incidence of tuberculosis and opportunistic infections decreased to less than two cases per 100 person-years.

The cost of Highly Active Antiretroviral Therapy (HAART) decreased in the due time, upto 20-fold, which resulted in the increasing number of individuals seeking treatment for HIV infection in the country. The production of ARV medications by Indian generic manufacturers since the year 2000 has reduced the price of combination HAART to less than one US dollar per day. This has increased the access to treatment in resource-limited regions in India.

The cost of HAART decreased from USD 778 per month in 1996 to USD 100 per month in 2000, the year in which generic ARV were made available in India, and to USD 33 per month in 2003. In 1996, only 13% of patients who qualified for HAART on the basis of the WHO guidelines were able to afford the therapy. However, the number has steadily increased to 22% in the year 2000 and to 44% patients who needed HAART receiving it in year 2003.

YRG CARE, one of the largest tertiary HIV care referral centres in India, conducted the study to investigate the impact of the introduction of the generic HAART by including 5711 adult HIV-infected persons who registered for care at the centre between 1996 and 2003 in the analysis. The most common antiretroviral regimen used was lamivudine, stavudine and nevirapine, which has administered to 56% of patients receiving HAART, administered as a fixed-dose combination of one pill to be ingested twice daily, followed by zidovudine, lamivudine and nevirapine as fixed combination, which has administered to 22% of patients receiving HAART.

The study observed that the nevirapine-based HAART, a formulation unavailable in the developed world because of patent protection laws, which is available in India as a one-pill, fixed-dose combination, marks a benefit to the country. The study also noted the current trend of an increase in the use of HIV-care services from 1996 to 2003 and an increase of 20% in the number of patients who can afford access to HAART within the time.

Although the incidence of opportunistic infections and death rate has decreased, the use of antiretroviral medications has resulted in adverse effects on the patients. Rash (8%) and nausea (8%) are the most common adverse effects and the pattern of adverse events with generic medicines was similar to patterns associated with proprietary medicines.

Eighty five per cent of patients with rash were receiving regimens that included nevirapine. Diarrhoea, headache, peripharal neuropathy and anaemia were the other prevalent symptoms observed. Majority of patients observed with anaemia were receiving treatment with zidovudine. Lipodystrophy was observed primarily in patients receiving stavudine-based HAART, which is currently the cheapest and the most widely available triple-drug regimen.

"The adverse effects, however, are very feeble when compared to the real threat of HIV, and the increasing access to generic HAART could be an effective means of using limited resources to provide needed treatment in areas where the epidemic continues to rapidly expand," said Dr.N.Kumarasamy, chief medical officer, YRG CARE who has participated in the study.

Dr.Suniti Solomon and Dr.Anitha.J.Cecelia of YRG CARE, Chennai, Dr.Sreekanth.K.Chaguturu, Snigdha Vallabhaneni, Timothy.P.Flanigan and Kenneth.H.Mayer of Division of Infectious Disease, Miriam Hospital, Brown University, Providence, Rhode Island were the other experts in the team.