POSITIVELY AWARE JULY/AUGUST 2011
In May, the Food and Drug Administration (FDA) approved Victrelis (boceprevir), and Incivek (telaprevir), two new hepatitis C virus (HCV) protease inhibitors. Both drugs are for genotype 1 infection, the most difficult of the HCV types to treat. They must be taken with the two older hep C treatments on the market, peginterferon alfa (PegIntron) and ribavirin (Rebetol), though they can both shorten treatment time by half. The FDA noted that the addition of Victrelis to PegIntron and Rebetol significantly increased the sustained virologic response (SVR) rates compared to PegIntron and Rebetol alone (by almost double, from 38% for people taking only the two older drugs to 63–66% for those also taking Victrelis). An SVR is considered a cure. For Incivek, the percentage of treatment-naïve people who achieved an SVR was 79%.
While the approval of these drugs marks a major step forward in the treatment of hepatitis C, advocates expressed dismay over the price of the drugs. Victrelis costs between $26,400 and $46,400, depending on the duration of treatment, which can range from 24-48 weeks. Incivek is also expensive—around $49,200 for 12 weeks of treatment. Both drugs must also be taken in combination with other hep C drugs that can cost as much as $30,000.
The Fair Pricing Coalition (FPC) is very disappointed at the price set for Victrelis and Incivek. “The FPC is concerned that the exorbitant wholesale acquisition cost (WAC) of $1,100 per week [for Victrelis] will adversely affect the ability of people with HCV to access Victrelis and that it will also set an excessively unreasonable future price point for the many HCV drugs in the pipeline,” said FPC member Lynda Dee.
Both Vertex and Merck have announced financial assistance and patient support programs to provide free drug to eligible patients who do not have insurance, and to provide coverage for co-pay or coinsurance costs associated with Incivek or Victrelis for people who meet certain program criteria.Call 855-837-8394 or go to incivek.com; or victrelis.com for details
On May 25, the FDA granted approval for a generic formulation of Combivir, a two-in-one HIV medication consisting of lamivudine and zidovudine (brand names Epivir and Retrovir). Both are from the drug class called nucleoside analog reverse transcriptase inhibitors (NRTIs). The tablets are manufactured by TEVA Pharmaceuticals USA. The generic will be available in the U.S.The FDA also granted tentative approval for a generic formulation of tenofovir
disoproxil fumarate (Viread) tablets under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR). This generic will not be available in the U.S. Tentative approval does, however, make the product eligible for purchase outside the U.S. under the PEPFAR program.
International research led by the National Institutes of Health (NIH) has now provided strong evidence that HIV treatment helps prevent transmission to HIV-negative sex partners. This is the first time that gold-standard research (a randomized, controlled clinical trial) has successfully demonstrated the concept of “treatment as prevention.”
The study found a 96% drop in the risk of HIV infection with the use of antiretroviral therapy.
“Previous data about the potential value of antiretrovirals in making HIV-infected individuals less infectious to their sexual partners came largely from observational and epidemiological studies,” said Anthony S. Fauci, MD, director of the National Institutes of Allergy and Infectious Diseases (NIAID), in a press release. “This new finding convincingly demonstrates that treating the infected individual—and doing so sooner rather than later—can have a major impact on reducing HIV transmission.”
CATIE (the Canadian AIDS Treatment Information Exchange) produced a comprehensive report on the HPTN 052 findings, along with links to past research and reports that shed light on the concept of treatment as prevention (including information from the U.S. Centers for Disease Control and Prevention, or CDC, which note that it is a promising, but not foolproof, avenue for lessening the risk of infection). Go to www.catie.ca.Read more about the HPTN 052 study here.
The HIV drug Ziagen has once again been associated with increased risk of heart trouble. This time, a review of patient data from the Veterans Administration suggests people taking Ziagen have an increased risk of heart disease and stroke. Also of interest in the analysis: tenofovir, Ziagen’s competitor, was associated with an increase in heart failure.
The research on Ziagen and heart problems has been good and bad for years. Writer Keith Alcorn examines the latest information and reviews some of the past research at www.aidsmap.com. The VA study was published in the May issue of AIDS. The VA researchers point out that there was a high rate of smoking in the entire group of patients who participated (half of them smoked). In addition, 40% of them had high blood pressure and nearly 20% of them had diabetes, both of which are associated with a higher risk of heart disease. In fact, one out of five of them already had a diagnosis of cardiovascular disease before going on Ziagen or tenofovir.
The generic name of Ziagen is abacavir; it is also found in Epzicom and Trizivir. The brand name of tenofovir is Viread, which is also found in Truvada and Atripla.Alcorn also reported more data showing that HIV infection may have a role in heart failure. That research, looking at a large group of U.S. military veterans, was published in the April 25 Archives of Internal Medicine. As he notes, the analysis “adds to the accumulating evidence that untreated HIV infection may increase the risk of heart disease.” Once again, this group had a high rate of smoking (55%). The researchers theorized that several factors may explain the risk: HIV itself, heavy alcohol use, HIV treatment side effects, nutritional deficiencies, and damage to the heart muscle.
The American Heart Association and the American Academy of HIV Medicine (AAHIVM) have created a new website to help people living with HIV make changes to improve their heart health and overall wellness.
www.HIVandYourHeart.org features informative videos from healthcare providers, a wellness checklist, an HIV quiz, and personal stories from patients and behavioral change coach Michael Patterson. HIV and Your Heart also has an application for the iPhone, iPad, and iPod Touch.
The interactive tracking tool helps patients define their goals and begin the steps necessary to make changes. It’s also confidential. The desktop icon is labeled “Your Heart” and the information you enter may be password-protected.
Cardiovascular disease (CVD) is a major cause of death in HIV patients and people living with HIV often share common factors that affect cardiovascular health, including:
- Higher triglyceride and “bad” cholesterol levels
- Chronic inflammation
- Kidney failure
“The good news, however, is that much of this risk for coronary heart disease is remedial,” said American Heart Association spokesperson and past president, Robert Eckel, MD, of the University of Colorado Denver School of Medicine and University Hospital, Denver, Colorado. “We have concluded that the development of optimized screening, prediction, and treatment algorithms for cardiovascular disease in HIV-infected patients is crucial and timely.”In a recent survey of Positively Aware website visitors and e-newsletter subscribers, 68% of HIV patients said they’re very interested in learning about HIV and CVD.