Indian drug maker Cipla on Thursday received tentative FDA approval to produce an oral version of the antiretroviral drug efavirenz, Reuters Health reports (Reuters Health, 5/29). The tentative approval designation means the drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 1/5). In January, former President Clinton announced an agreement reached by the Clinton Foundation that will allow the sale of efavirenz produced by Indian companies Cipla, Ranbaxy Laboratories and Strides Arcolab, as well as South Africa's Aspen Pharmacare, to people in developing countries for no more than $240 per patient annually. In March, Merck announced that it is reducing the price of efavirenz in developing countries by 20% from 95 cents daily to 76 cents daily, making the new annual cost of the drug $277.40 for the 600 milligram formulation (Kaiser Daily HIV/AIDS Report, 3/7).
Monday, September 11, 2006
FDA Grants Cipla Tentative Approval for Oral Version of Antiretroviral Drug Efavirenz
California Could Lose Millions in HIV/AIDS Funding Under Revisions for Ryan White CARE Act Reauthorization
California could lose millions in HIV/AIDS funding under proposed revisions to the Ryan White CARE Act, the Los Angeles Times reports (Lin, Los Angeles Times, 5/29). The Senate Committee on Health, Education, Labor and Pensions earlier this month voted 19-1 to approve a bill (S 2823) that would alter the CARE Act by allocating more federal HIV/AIDS funding to Southern and rural states. The bill would revise the funding calculation formulas to include HIV cases and not just AIDS cases. In addition, the bill, sponsored by HELP Committee Chair Mike Enzi (R-Wyo.) and Sen. Edward Kennedy (D-Mass.), would create a multilevel funding system according to city size in an effort to distribute funds to more rural states. The bill also would mandate 75% of funding go to medical services such as medications and physician visits, and also would set a minimum drug formulary (Kaiser Daily HIV/AIDS Report, 5/18). If the measure becomes law, San Francisco could lose one-fourth of the $28 million in CARE Act funding it receives annually, according to Scott Boule, assistant policy director for the San Francisco Department of Public Health. The Sacramento region could lose all of its $3 million in federal funding, Adrienne Rogers, coordinator of CARE Act programs in the area, said. In addition, federal funding for HIV/AIDS programs in Orange County could decrease from $4.8 million to $1 million within five years, according to Donna Fleming, a disease control manager for the county. "We will not even be able to cover our basic medical care needs," Fleming said, adding, "That's how devastating it is" (AP/San Jose Mercury News, 5/29). Sen. Tom Coburn (R-Okla.) said, "Since we're in a limited budget, the intent is to distribute the money fairly, not disproportionately and unfairly" (Los Angeles Times, 5/29). Coburn in March also introduced a bill (S 2339) that would reauthorize and amend the CARE Act (Kaiser Daily HIV/AIDS Report, 5/17). Michael Montgomery, chief of the Office of AIDS at the California Department of Health Services, said that California's losses might be partly offset by a provision in the bill that would remove a formula that has undercounted the number of AIDS cases in the state by predicting deaths earlier than they occur (Los Angeles Times, 5/29).
In the event of lost funding or other financial hardship, please visit AIDS-DRUGS-ONLINE.com
Alcohol Increases the risk
"Alcohol Use Before Sex and HIV Acquisition: A Longitudinal Study in Rakai, Uganda," AIDS: Iryna Zablotska of the National Centre in HIV Social Research and colleagues examined approximately 6,800 men and more than 8,000 women ages 15 to 49 in Rakai, Uganda, to determine if consuming alcohol before sexual intercourse is linked to an increased risk of HIV transmission. The study -- conducted between 1994 and 2002 -- finds that consuming alcohol prior to sexual intercourse increases the risk of acquiring HIV by 67% for men and by 40% for women. The study also finds that if both partners consume alcohol, the risk increases by 58% for men and by 81% for women (Xinhuanet, 5/31).
GSK to Reduce Price of Some Anitretrovirals Sold in Developing Nations
GlaxoSmithKline on Tuesday announced that it is reducing by about 30% the cost of some of its antiretroviral drugs currently sold at not-for-profit prices in developing countries, Reuters reports. Under the cost reductions, which will take effect on July 1, 60-tablet packs of Trizivir and Ziagen will cost about $70.00 and $52.29, respectively (Reuters, 5/30). The drug company also announced that it will make Kivexa and Telzir available at not-for-profit prices once they have been approved by drug regulatory bodies in developing nations (GSK release, 5/30). GSK plans to differentiate drug shipments intended for not-for-profit markets to ensure they are not diverted back to for profit markets. In addition, the company has signed its eighth voluntary licensing agreement with South Africa-based Sonke Pharmaceuticals, which will allow Sonke to make generic versions of some of its drugs (Reuters, 5/30). In 2003, GSK announced that it was reducing the price of its AIDS drugs by as much as 47% for 63 nations, including all of sub-Saharan Africa. The reduced pricing scheme is available to not-for-profit groups, governments, aid agencies and companies that provide the drugs to their employees (Kaiser Daily HIV/AIDS Report, 4/28/03).
For access to cheap antiretroviral drugs, please visit www.aids-drugs-online.com
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