This week, in the third and fourth widely reported studies of AIDS prevention medications, two new studies have supported Gilead’s Truvada to be key in the possible significant prevention of HIV contraction when compared to a placebo in studies conducted in Botswana, Uganda and Kenya amongst heterosexual men and women.
One of the studies released Wednesday and spearheaded by the U.S. Centers for Disease Control and Prevention, involved just over 1,200 sexually active men and women living in Botswana Half of the group took Truvada, while the rest received a placebo. Just four people on Truvada became infected with HIV in comparison with 19 on the fake pill. That means Truvada takers cut their risk of infection by approximately 78%.
The second study involved 4,758 heterosexual couples in Uganda and Kenya, in which one partner was HIV positive and one was negative. Results demonstrated that there were 13 HIV infections among those on Truvada, 18 for those who took Viread and 47 on the fake pills. That means the HIV treatment pills reduced the chance of infection by 62% to 73%.
An independent review panel this week said the benefit was so obvious that they deemed it unethical to withhold the drugs from placebo-takers and switched their treatments, said Dr. Jared Baeten, the University of Washington researcher who co-chaired the study with the Gates Foundation.
Kevin Fenton, M.D., director of CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention said:
“These are exciting results for global HIV prevention. We now have findings from two studies showing that PrEP can work for heterosexuals, the population hardest hit by HIV worldwide. Taken together, these studies provide strong evidence of the power of this prevention strategy.”
Gilead is is a major producer of AIDS drugs. Also this week, United Nations health officials announced the company had agreed to allow some of its drugs to be made by generic manufacturers, potentially increasing their availability in poor countries.
Mylan now holds the right to produce and market generic versions of Gilead’s HIV/AIDS therapies if they are approved by regulators, and also can expand production and marketing of several other Gilead products to 16 additional countries.
The availability of cheap antiretroviral drugs has been instrumental in treatment scale-up for resource-poor settings hard hit by the AIDS epidemic. Around 5.25 million people in low- and middle-income countries are currently receiving drugs to treat HIV/AIDS. This would simply not have been possible without a reduction in the price of antiretroviral drugs (ARVs).
Under terms of the deal, Mylan now holds the right to produce and market generic versions of Gilead’s HIV/AIDS therapies if they are approved by regulators. In addition, the broadened arrangement allows Mylan to expand production and marketing of several other Gilead products to 16 additional countries.
Michelle Childs, a director at Doctors Without Borders adds:
“This agreement is an improvement over what other big pharma companies are doing to ensure access to their patented AIDS medicines in developing countries.”
Mylan offers one of the broadest and highest quality generic and specialty pharmaceutical product portfolios in the industry. The company maintains a robust pipeline and provides a wide array of dosage forms and delivery systems through an expansive global commercial footprint. Through its subsidiary Matrix Laboratories, Mylan has direct access to one of the world’s largest active pharmaceutical ingredient (API) manufacturers. This relationship makes Mylan one of only two global generics companies with a comprehensive, vertically integrated supply chain. Matrix also is one of the world’s largest producers of API used to make generic antiretroviral (ARV) therapies for the treatment of HIV/AIDS.
Roughly 33 million people worldwide have HIV, the virus that causes AIDS, and live in Africa and Asia where medicines to treat the virus must be affordable in order for those who have little funds to buy the drugs. One of the four drugs will also be used to treat people with hepatitis.
Dr. Lynn Paxton of the CDC said:
“This is good news. This is a good day for HIV prevention.”
Sources:
Written by Sy Kraft