Antiretroviral Medications — From Thailand to Africa
http://www.100md.com
《新英格兰医药杂志》
The international AIDS conference highlighted the substantial progress that Thailand has made in reducing the frequency of mother-to-child transmission of HIV and providing antiretroviral treatment. Now, Krisana Kraisintu, the Thai pharmaceutical chemist who helped to spearhead her nation's response to AIDS, has embarked on a self-assigned mission — to bring affordable antiretroviral treatment to three African countries.
Kraisintu is the former director of the Research and Development Institute of the Government Pharmaceutical Organization (GPO) in Thailand and a pioneer in the production of generic antiretroviral medications. In 1995, she brought antiretroviral treatment to Thailand by producing zidovudine to protect newborns from HIV. After she started making didanosine, she battled Bristol-Myers Squibb over the Thai patent for the drug. Kraisintu claimed that the company's patent was not valid because the medication had been invented at the National Institutes of Health. Early this year, as a court battle approached, Bristol-Myers Squibb backed down and stopped defending the patent.
In 2001, Kraisintu invented a fixed-dose generic combination drug known as GPO-VIR, which contains either 30 or 40 mg of stavudine, 150 mg of lamivudine, and 200 mg of nevirapine (see Figure). At the time, patients receiving this regimen took six pills a day at a cost of about $85 a month. Production of GPO-VIR began in 2002. Patients take two pills a day at a cost of $27 a month, or $324 a year. GPO-VIR is now used by about three quarters of the more than 30,000 people being treated for HIV infection in Thailand. Kraisintu worked in the laboratory to reduce the costs of antiretroviral treatment and advocated within the Ministry of Public Health for broader availability of the medications. Subsequently, the Thai government has established a policy of universal coverage for antiretroviral treatment.
"When I first started, nobody believed that it is possible that we would arrive at this stage," Kraisintu said in an interview at the International AIDS Conference in Bangkok. "I never believed it. When I first worked on this, I hoped that everyone would be treated, without realizing any difficulties. Suddenly, more and more patients have been treated, and all will be treated in the future. My goal has been achieved in Thailand, I think." The GPO now manufactures 6 types of antiretroviral medication in 24 variants, with sufficient production for 35,000 patients. Increased production is planned, as well as a new production facility with improved quality standards.
Kraisintu stepped back from her work at the GPO, and she left entirely at the end of 2003. Working on her own, with support from Action Medeor, a German medical aid organization, and others, she now aims to bring the production of her fixed-dose combination to Eritrea (where 60,000 people are infected with HIV), the Democratic Republic of Congo (where 1.1 million are infected), and Tanzania (1.6 million).
In each country, Kraisintu has found unique challenges. These include armed conflicts in Eritrea and the Democratic Republic of Congo, the isolated desert location of the facility in Eritrea, manufacturing and management issues in Tanzania, poverty, and cultural and language barriers. Annual medication costs in Eritrea and the Democratic Republic of Congo, where initial production would be sufficient for only several thousand patients, might be about $240. In Tanzania, where the goal is medication for 30,000 people, the annual cost might be $120. Production has yet to begin, although it may start in some of the nations before the end of the year. In a related effort, Kraisintu's work has allowed Tanzania Pharmaceutical Industries to manufacture the antimalarial medication artemisinin.
To replicate the success in Thailand, Kraisintu will have to demonstrate that antiretrovirals can be produced in the three countries without interruption, that production can be scaled up, and that the quality of the medications meets international standards. These remain daunting challenges. Kraisintu said she is motivated by a sense of fairness and a view of AIDS as a social as well as a health problem. "I think everybody should get access to treatment. It is a basic human right," she said. "If it is unfair, I will fight to the end. It doesn't matter what it costs me."(Robert Steinbrook, M.D.)
Kraisintu is the former director of the Research and Development Institute of the Government Pharmaceutical Organization (GPO) in Thailand and a pioneer in the production of generic antiretroviral medications. In 1995, she brought antiretroviral treatment to Thailand by producing zidovudine to protect newborns from HIV. After she started making didanosine, she battled Bristol-Myers Squibb over the Thai patent for the drug. Kraisintu claimed that the company's patent was not valid because the medication had been invented at the National Institutes of Health. Early this year, as a court battle approached, Bristol-Myers Squibb backed down and stopped defending the patent.
In 2001, Kraisintu invented a fixed-dose generic combination drug known as GPO-VIR, which contains either 30 or 40 mg of stavudine, 150 mg of lamivudine, and 200 mg of nevirapine (see Figure). At the time, patients receiving this regimen took six pills a day at a cost of about $85 a month. Production of GPO-VIR began in 2002. Patients take two pills a day at a cost of $27 a month, or $324 a year. GPO-VIR is now used by about three quarters of the more than 30,000 people being treated for HIV infection in Thailand. Kraisintu worked in the laboratory to reduce the costs of antiretroviral treatment and advocated within the Ministry of Public Health for broader availability of the medications. Subsequently, the Thai government has established a policy of universal coverage for antiretroviral treatment.
"When I first started, nobody believed that it is possible that we would arrive at this stage," Kraisintu said in an interview at the International AIDS Conference in Bangkok. "I never believed it. When I first worked on this, I hoped that everyone would be treated, without realizing any difficulties. Suddenly, more and more patients have been treated, and all will be treated in the future. My goal has been achieved in Thailand, I think." The GPO now manufactures 6 types of antiretroviral medication in 24 variants, with sufficient production for 35,000 patients. Increased production is planned, as well as a new production facility with improved quality standards.
Kraisintu stepped back from her work at the GPO, and she left entirely at the end of 2003. Working on her own, with support from Action Medeor, a German medical aid organization, and others, she now aims to bring the production of her fixed-dose combination to Eritrea (where 60,000 people are infected with HIV), the Democratic Republic of Congo (where 1.1 million are infected), and Tanzania (1.6 million).
In each country, Kraisintu has found unique challenges. These include armed conflicts in Eritrea and the Democratic Republic of Congo, the isolated desert location of the facility in Eritrea, manufacturing and management issues in Tanzania, poverty, and cultural and language barriers. Annual medication costs in Eritrea and the Democratic Republic of Congo, where initial production would be sufficient for only several thousand patients, might be about $240. In Tanzania, where the goal is medication for 30,000 people, the annual cost might be $120. Production has yet to begin, although it may start in some of the nations before the end of the year. In a related effort, Kraisintu's work has allowed Tanzania Pharmaceutical Industries to manufacture the antimalarial medication artemisinin.
To replicate the success in Thailand, Kraisintu will have to demonstrate that antiretrovirals can be produced in the three countries without interruption, that production can be scaled up, and that the quality of the medications meets international standards. These remain daunting challenges. Kraisintu said she is motivated by a sense of fairness and a view of AIDS as a social as well as a health problem. "I think everybody should get access to treatment. It is a basic human right," she said. "If it is unfair, I will fight to the end. It doesn't matter what it costs me."(Robert Steinbrook, M.D.)