FDA Advisory Committee Unanimously Recommends Accelerated Approval of the HIV Entry Inhibitor Maraviroc
On Tuesday, April 24, the Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee unanimously recommended accelerated approval of the anti-HIV drug, maraviroc. Maraviroc prevents HIV from binding to CCR5, one of two receptors HIV can use to enter human immune cells. If approved, maraviroc would represent the first new class of oral antiretroviral drugs in a decade.
The committee's recommendation was based mainly on data from two Phase III studies in treatment-experienced individuals. At 24 weeks, study participants receiving maraviroc plus optimized background therapy (OBT) achieved an undetectable viral load compared to those receiving a placebo and OBT. In addition, participants receiving maraviroc experienced a significant increase in CD4 cells/mm3.
The Advisory Committee did express some concerns over the long-term use of maraviroc. While maraviroc was well tolerated, some adverse effects were noted. These included some increase in cardiac ischemic events; a mild increase in total cholesterol and LDL levels; and a slight increase in herpes simplex, upper respiratory tract, Candida, and influenza infections. In addition, the committee requested that further data be collected on the effects of maraviroc in women, children, and minority populations.
Study Shows HIV Infection Is Associated with Increased Heart Attack Risk
According to a recent study, HIV infected individuals face almost double the risk of heart attack as their uninfected counterparts even when heart disease risk factors are taken into account.
Dr. Steven Grinspoon and his team evaluated data from almost 4,000 HIV infected individuals aged 18 to 84. Results of this study indicate that people infected with HIV have nearly twice the risk of suffering a heart attack compared to age-matched controls. Women were found to be at especially high risk--data from this study show that HIV infected women have almost triple the odds of having a heart attack.
Despite the strong data, researchers are still unsure whether the virus itself or side effects of anti-HIV medications increase the risk of heart attack in HIV infected individuals. Highly Active Antiretroviral Therapy (HAART) improves the cardiovascular condition by suppressing inflammation associated with HIV infection, but HAART side effects, such as hyperlipidemia and lipodystrophy, put HIV infected individuals at higher risk of developing heart disease. Regardless of the findings, the study's authors emphasized that the benefits of HAART outweigh the risks and it is imperative that HIV infected individuals adhere to their prescribed regimens.
FDA Grants Tentative Approval to Generic Formulation of Stavudine
On Monday, April 23, the FDA granted tentative approval to a generic formulation of stavudine.
For complete details, please read the full announcement from the FDA.
Kaletra Product Information Updated
Product labeling for Kaletra (lopinavir/ritonavir) was updated this week with new safety and efficacy data.
For more details and the complete product labeling, please read the full announcement from the FDA.