Phase III trials for the anti-HIV medicine Truvada. Gilead, the global leader in treatments for human immunodeficiency virus that causes AIDS, derives 80 percent of its $5 billion in annual sales from AIDS treatments. The company markets Atripla, a three-in-one daily pill containing its dual drug pill Truvada plus Bristol-Myers Squibb Co.’s Sustiva.
President and COO of Gilead Sciences Inc. (GILD) John F Milligan.
“The fixed dose Quad pill is the most exciting thing we’re working on,” Milligan said.
The Quad pill would be Gilead’s first to combine only its own AIDS drugs, Milligan said. It would contain the two-in-one HIV pill Truvada, plus Gilead’s new compound elvitegravir that blocks an enzyme called integrase that the virus needs to insert itself into its victim’s genes. The Quad also would include a booster medicine Gilead developed.
A main advantage of the new pill is that it would offer an alternative for those who can’t tolerate Sustiva’s central nervous system side effects, including bad dreams and hallucinations, Milligan said. In addition, birth defects seen in animal studies of Sustiva could also make some doctors reluctant to prescribe the drug for women who may have children.
The Quad pill would be especially important for persons of African descent who are hardest hit by the virus, because they metabolize Sustiva more slowly, making its side effects more pronounced, according to Milligan.
“If Sustiva isn’t useful, the Quad may be of more benefit,” Milligan said.
Recently another trial was started by the NIH called the Voice Study
VOICE study, a major HIV prevention trial for women, is launched in Zimbabwe
More than a dozen clinical trials are underway to determine whether various gels can prevent male-to-female or male-to-male transmission of HIV infection. These trials are part of a global effort to identify a safe, effective microbicide that could be applied topically to protect users against HIV and other sexually transmitted infections (STIs). There are no proven effective microbicides at this time; ongoing clinical trials, including efficacy trials of candidates using different strategies, will yield results in the coming years. As with any new experimental intervention, the first candidates are expected to be partially effective; however even a partially-effective microbicide could potentially be a powerful prevention tool when used alongside existing prevention strategies such as male and female condoms, risk reduction counselling, and diagnosis and treatment of sexually transmitted infections.
What is Truvada?
•Truvada is an HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Truvada prevents HIV from altering the genetic material of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
•Truvada is marketed by Gilead Sciences. It was approved by the U.S. Food and Drug Administration (FDA) for use by people living with HIV in August 2004.
•Truvada is a combination of two drugs: 300mg of Viread (tenofovir DF) and 200mg of Emtriva (FTC). Truvada should be prescribed by a healthcare provider for patients who need both of these drugs. Both of these drugs can still be purchased individually for use in combination with other HIV drugs.
•Truvada must be combined with at least one other HIV drug, usually a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI).
•Atripla, a combination tablet containing the NNRTI Sustiva (efavirenz) and the tenofovir and emtricitabine in Truvada, was approved for use in the United States in July 2006. Truvada can still be purchased for use in combination with HIV drugs other than Sustiva.
•Both the Viread and the Emtriva in Truvada are active against the hepatitis B virus (HBV), the virus responsible for causing hepatitis B. Although Emtriva and Viread have not been approved by the FDA for the treatment of hepatitis B, some doctors may prescribe Truvada to treat both hepatitis B and HIV. See What about side effects? below for more important information regarding Viread, Emtriva, and hepatitis B.
•Gilead has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Truvada. To learn more about the PAP for Truvada, call Gilead (800-226-2056). For those with private health insurance, Gilead has established a program to help cover up to $200 toward each monthly Truvada co-payment (people will be responsible for paying the first $50 of their monthly Truvada co-payment). To learn more about this co-pay program, call 866-784-3431.
Where can I learn more about clinical trials involving Truvada?
•If you would like to find out if you are eligible for any clinical trials that include Truvada, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
•Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the US National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).