POSITIVELY AWARE JANUARY/FEBRUARY 2011
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On November 10, the U.S. Food and Drug Administration (FDA) approved Egrifta (generic name tesamorelin), a once-daily injection for the treatment of lipodystrophy in HIV-positive people (see The Buzz on p. 34). Lipodystrophy is a condition which includes abnormalities in body fat distribution and metabolism, and is associated with many HIV drugs. The greatest concern is visceral fat, the layer that sits on the liver, stomach, and other abdominal organs, because there is a direct correlation with increased risk of developing heart disease, high blood pressure, diabetes, sleep apnea, stroke, certain types of cancer, and other diseases. Moreover, it decreases quality of life and has been known to keep people from starting HIV therapy, or to cause them to stop taking it. Egrifta is the first FDA approved treatment for lipodystrophy. According to an FDA press release, “Egrifta was evaluated in two clinical trials involving 816 HIV-infected adult men and women with lipodystrophy and excess abdominal fat. Of these, 543 patients received Egrifta during a 26-week, placebo-controlled period. In both studies, patients treated with Egrifta experienced greater reductions in abdominal fat (15-17%) as measured by CT scan, compared with patients receiving another, non-active injectable solution (placebo). Some patients reported improvements in their self image.” Prescriptions must be filed with EMD Serono’s Axis program (877-714-2947) and will be handled by select mail-order pharmacies. The Axis program will assume responsibility for seeking reimbursement for the drug, working directly with insurance companies and prescribers. EMD Serono, which is marketing the drug in the U.S., will also have a co-pay program to help cover drug co-pays for those with insurance, and a patient assistance program (PAP) for those who are underinsured or without insurance. Visit www.emdserono.com or www.egrifta.com.
In November, Gilead Sciences submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a combination of its Truvada medicine and TMC278, an experimental HIV non-nucleoside analogue (the same class of medication as Sustiva), from Tibotec Pharmaceuticals. Expected to be approved in 2011, the new medication is the second HIV treatment that provides an entire regimen in one pill. The popular Atripla, consisting of Truvada and Sustiva, was the first.
In October, Merck announced an enhanced co-pay assistance program for its HIV drug Isentress. The program removes the previously required $30 co-pay and is good for out-of-pocket costs up to $400, making this the most generous co-pay assistance program out there for an HIV drug. The program is for privately insured individuals with out-of-pocket co-pays. HIV treatment advocates from the Fair Pricing Coalition, including Positively Aware editor Jeff Berry, have been working with pharmaceutical companies to alleviate the financial pressures of antiretroviral therapy (see the Annual HIV Drug Guide in Positively Aware’s March/April issue). For more information, call 1-877-264-2440 or visit www.Isentress.com.
As Positively Aware went to press in December, the U.S. Food and Drug Administration (FDA) was set to approve a new use (indication) for the Gardasil vaccine. Gardasil is a vaccine that protects men and women from four kinds of human papillomavirus (HPV). HPV can cause genital and other warts in both men and women and cervical cancer in women. In November, an FDA advisory committee determined that data on Gardasil support its approval for the prevention of anal cancer and anal intraepithelial neoplasia (AIN, a precursor to cancer) in both males and females.
Principle investigator Joel Palefsky, MD, of the University of California, San Francisco, is a leader in the research and treatment of anal cancer, particularly in the high-risk population of men who have sex with men (MSM), as well as people with HIV. There is no contraindication against Gardasil for HIV-positive people, he told Positively Aware. Furthermore, he said, “I strongly believe we should be doing a better job of educating MSM, whether positive or negative, to get vaccinated as early as possible.” A big question will be answered later this year, he noted, when a decision is made on whether to recommend Gardasil for protection against anal cancer and disease by the Advisory Committee for Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC). Insurance reimbursement and government payment for Gardasil rests on the strength of an ACIP recommendation.
The data reviewed were from a study of MSM, and was related to use of the vaccine in both men and women because anal cancer affects both sexes and the disease is similar in both.
There’s good news for HIV prevention. The vaginal gel which the CAPRISA 004 study (see the September/October issue of Positively Aware) showed was able to significantly cut the risk of HIV has been put on the fast track to approval by the U.S. Food and Drug Administration (FDA). In a meeting on October 20, the FDA agreed to give the gel, a formula containing 1% of the HIV medication tenofovir (brand name Viread, which is also contained in the antivirals Truvada and Atripla), a Fast Track approval designation. This means that the agency will consider study findings as they are completed, rather than waiting for all results to be finished. The agency designated another study from the Microbicide Trials Network, or MTN, called VOICE (Vaginal and Oral Interventions to Control the Epidemic), also known as MTN-003, as all that is needed for approval if results confirm those of the South African trial. Unlike the CAPRISA study, however, in which women used tenofovir gel up to 12 hours before and up to 12 hours after sex, VOICE looks at daily use of the microbicidal gel. It is also studying daily oral use of tenofovir tablets in addition to the gel (in separate arms of the trial).
The U.S. Food and Drug Administration (FDA) in October added a warning to the drug label for the HIV medication Invirase, which is always taken with a booster dose of another HIV drug, Norvir. According to the FDA, there is a potential for change in the electrical activity of the heart when Invirase/Norvir is used, which may lead to abnormal heart rhythms. Patients should not stop taking Invirase before first consulting their doctor, the FDA advises.
The anti-HIV combo drug Truvada (tenofovir/emtricitabine, or TDF/FTC) was shown to actually cut the risk of acquiring HIV in people at high risk of infection who took the pill every day. Overall, there was a 44% reduction in the risk of becoming infected with HIV, but a 73% reduction for those people who took the daily pill 90% of the time, according to a study called iPrEx, published in the November 23rd issue of the New England Journal of Medicine. This is the first time that the HIV prevention strategy called pre-exposure prophylaxis (prevention), or PrEP, provided evidence of effectiveness in humans during a study. “The iPrEx study proves that PrEP provides important additional protection against HIV when offered with other prevention methods such as HIV testing, counseling, condom use, and management of sexually transmitted infections,” said iPrEx protocol chair Robert Grant, MD, MPH in a press release. “As with other prevention methods, the greatest protection comes with consistent use. I hope this finding inspires a renewed commitment from communities, industry, and government to stop the spread of HIV.” Grant is with the Gladstone Institutes and the University of California, San Francisco. The iPrEx results are from 2,499 men and transgender women who were born men, all of whom have sex with men and 40% of whom had exchanged sex for money. In addition to counseling for safer sex practices and medication adherence, plus condoms and regular HIV testing, half of the participants were given Truvada and the other half received a placebo (fake pill). There were 36 infections in the Truvada group vs. 64 infections in the placebo group. The study took place at 11 sites in Brazil, Ecuador, Peru, South Africa, Thailand, and the United States. It was funded by the U.S. National Institutes of Health (NIH), with additional support from the Bill & Melinda Gates Foundation.
Alas. A study found that a once-daily dose of Isentress did not do as well as the FDA approved twice-daily dose. Although the experimental once-daily dose got 83.2% (318/382) of study participants taking it down to an undetectable HIV viral load of less than 50 copies at 48 weeks, it was not shown to be non-inferior to the twice-daily dose, manufacturer Merck reported in November. That compares to 88.9% of participants (343/386) on the twice-daily dose who achieved undetectable viral load. The study was stopped and the company recommended that people on the once-daily dose be switched to twice-daily dosing. The company said the difference was driven by people with high viral loads of more than 100,000. Of the once-daily participants, 74.3% (113/152) had undetectable viral loads vs. 84.2% (129/152) of the twice-daily group. Safety and tolerability was the same for the two groups. Study participants were taking HIV medicine for the first time.