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Issue dated - 10th April 2003

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Roche launches pegylated interferon for HCV treatment

EPP News Bureau - Mumbai

Roche Scientific Company (India) Pvt Ltd, the Indian arm of Swiss multinational F Hoffman La Roche, last week announced the launch of Pegasys (pegylated interferon alfa-2a, 40KD) for the treatment of hepatitis C infection in adults. Roche estimates 24 million hepatitis C infection cases in India with a threat of progressing into chronic stage.

Pegylated interferon is an improvement over conventional interferon in the sense that pegylation allows for true seven-day viral suppression and the drug is preferentially distributed to the liver - the primary site of infection. In other words, pegylated interferon minimises the frequency of interferon dosage and with Pegasys in particular, the recommended dosage is once a week as against two to three times a week with other interferon brands available in the country. Roche has decided to offer ribavarin - a co-prescription drug indicated with interferon for HCV treatment - free of cost to patients in India on Pegasys therapy, Dr G L Telang, managing director, Roche Scientific Company told at a media briefing in Mumbai.

However, it remains to be seen how much HCV patients will Roche cater to in India. Despite conventional interferon being available in the market in the price range of Rs 1000-1500 per dose (Rs 3,000-4,500 per week therapy cost), “only fifty per cent of the two per cent HCV cases diagnosed every year receive or take interferon treatment,” Roche informed. Even if the cost of locally available ribavarin is taken into account, the per-week treatment cost comes to Rs 3,900-5,400 with conventional interferons. As against this, the price of Pegasys in India will be in the range of Rs 13,000 to Rs 14,000 per dose.

The combination of Pegasys and ribavarin significantly enhances the sustained viral response (defined as undetectable virus) in 90 per cent of patients with HCV genotype 2, 77 per cent in genotype 3 patients and 51 per cent in genotype 1 patients, a Roche release says. The company is presently supplying Pegasys on a special licence to the Indian army, Dr Telang informed.

Roche says besides the dosage convenience, Pegasys also helps patients maintain high quality of life with “significantly less” side effects such as fatigue, pain, emotional limitations and vitality associated with conventional interferons. This, according to Dr Jens Rasenack - professor of medicine in the department of Gastroenterology and Hepatology at the Albert-Ludwigs-University, Germany and the author of health-related quality of life analysis study -, makes it more likely that patients under Pegasys are more likely to complete their treatment and ultimately improve their chances of being cured. “We know that many patients do not adhere to their hepatitis C treatment because the side-effects are often considered by patients to be more objectionable than the symptoms of the disease.

Meanwhile, Roche has appointed Delhi-based Taksal Pharma for distribution of Roche products in India. The agreement involves six products, the marketing rights for which Roche took back from Nicholas Piramal (NPIL). NPIL holds marketing rights for Referon and Neupogen till 2004, Vesanoid till 2005 and Recormon till 2007. Dr Telang indicated that all products of Roche in future too would be distributed by Taksal Pharma. “The new distribution structure will have full technical facility and expertise of Roche,” Dr Telang said. Roche plans to launch a couple of pegylated products in the treatment of oncology and nephrology in India in the near future. It is also trying to set up a transplant registry for kidney transplant cases in India. The company is also scouting for licensing new drugs in the areas of oncology, virology and nephrology from India, Dr Telang informed.

India does not need Fuzeon: Roche

Roche said that India does not need Fuzeon - a new class of drugs called fusion inhibitors to be launched by Roche in the US and Europe for the treatment of resistant HIV/AIDS. “Fuzeon is really indicated for HIV/AIDS patients who have become resistant to the existing ani-retrovirals. India has a very low percentage of resistant cases and do not need Fuzeon,” Dr G L Telang, managing director of Roche Scientific Company said.

Confirming this, Dr I S Gilada, an expert on treating HIV/AIDS cases in Mumbai, said resistance levels in the country is not more than three per cent. “Resistance levels are very low in India. This is because India has a total of 17 drugs for the treatment of HIV/AIDS. These can be classified into nucleotide reverse transcryptase inhibitors (NRTIs) and non-nucleotide reverse transcryptase inhibitors (NNRTIs). A standard treatment involves two NRTIs in combination with one NNRTI. So, even if patients develop resistance to one combination, they can be shifted to other drugs. This way, India can tackle the resistance problems for a minimum of ten years,” Dr Gilada informed.

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