The generic antiretroviral drugs manufactured by Indian companies are excellent in safety, tolerability and effectiveness, according to a research conducted by the Y R Gaitonde Centre for AIDS Research and Education (YRG CARE), Chennai.

In the two-year study conducted among 333 patients, the group of experts of YRG treated the patients with generic High Active Antiretroviral Therapy (HAART), which included drugs like nevirapine in combination with zidovudine/lamivudine, stavudine/lamivudine or stavudine/didanosine. Indian generic HAART was used for at least 12 weeks, reflecting 279 person-years’ experience and at the initiation of HAART, the median CD4 cell count was 171cells/mm3. The study showed the median increase in CD4 cell count of 109 patients within 6 months was 173cells/mm3 from baseline. Within the next six months, the number of patients who were ready for the follow up reduced to 75. The median increase in CD4 cell count from baseline in this group was 192cells/mm3.

The study found out that the median increase in CD4 cell count from baseline was greater in patients who were antiretroviral naive than in patients who had previous dual nucleoside therapy. The 92 patients who were antiretroviral naive, has increased their cell count by 196cells/mm3, while the 15 patients who were previously on nucleoside therapy has 110cells/mm3 as CD4 cell count.

Among the patients, 26% developed side effects of anaemia, diarrhoea, peripheral neuropathy, hepatitis or rash attributed to the HAART regimens during the treatment. Sixteen per cent of patients discontinued HAART in which 10% withdrawn from the treatment because of side effects. The study says that 33 patients developed opportunistic infections while on HAART. The expert’s analysis showed that the patients who started generic HAART below a CD4 cell count of 100 cells/mm3 were more likely to develop an opportunistic infection.

Though low cost generic antiretroviral drugs were available in India from 1994, many of the developing countries raised concerns that generic medicines may not be equivalent to proprietary therapeutic agents. It was mainly due to these concern, the centre has conducted study to check the safety, tolerability and effectiveness of generic drugs manufactured in India, said Dr. Kumaraswamy, chief medical officer, YRG CARE.