The US’s Food and Drug Administration (FDA) has for the first time approved a drug to prevent HIV infection through sexual activities. The drug, Truvada, is in use since 2004 as a part of retroviral therapy for HIV-I but the FDA green signal on Monday makes it the first approved drug for prevention of the dreaded virus.
Though medically it is a significant step in control of HIV-AIDS, doctors in India say the prohibitive cost of the drug — $14,000 annually — is unlikely to make it a potent weapon from the public health perspective in this country.
The pill has to be taken once daily for prevention of infection but the FDA statement says that it should ideally be used in combination with safe sex practices.
The results of clinical trials for efficacy of the drug were found promising. The risk of infection was reduced by 42 per cent in a study sponsored by the National Institutes of Health of about 2,500 HIV-negative gay and bisexual men and transgender women, and by 75 per cent in a study sponsored by the University of Washington of about 4,800 heterosexual couples in which one partner was HIV-positive and the other was not.
The drug is a combination of two anti-retroviral medications used to treat HIV-tenofovir disoproxil fumarate and emtricitabine.
Debra Birnkrant, director of the Division of Antiviral Products at FDA, says Truvada works to prevent HIV from establishing itself and multiplying in the body. “In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is.
Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time. But it is still better to prevent HIV than to treat a life-long infection of HIV,” she says
FDA has also laid down a number of conditions for prescription of the drug, all geared towards ensuring that there isn’t already an infection. Hence flu-like symptoms are a red flag. The drug also cannot be used if there is a hepatitis B infection as the disease often tends to get worse when Truvada use is stopped.
India has a substantial load of new infections though the absolute numbers have gone down in the past 10 years. In 2007, there were an estimated 2.5 million new cases.
However, Truvada, principally because of its cost, is unlikely to emerge as a public health option in fighting HIV-AIDS in India, says Dr C S Pandav, professor and head of the centre of community medicine at AIIMS and president of the Indian Public Health Association.
“The cornerstones of HIV-AIDS programme in India would have to remain A (for abstinence), B (for be faithful) and C (for condoms). The average per capita income in India is about $1,000, how can we even think of adopting a drug that costs $14,000 annually,” Dr Pandav says.
source
No comments:
Post a Comment