FDA panel recommends Gilead's Quad for HIV
WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel of outside experts on Friday recommended the use of Gilead Sciences Inc's Quad pill for untreated HIV patients.
The FDA advisory committee voted 13-1 to endorse the four-drugs-in-one treatment, but members said there should be effective monitoring for potential kidney problems among patients and urged further research to determine the drug's safety profile for women, who have been underrepresented in clinical research.
The panel's recommendation will now be taken into account by agency regulators, who are expected to decide on final approval for Quad by Aug. 27.
An overwhelming number of the experts said they were satisfied with Gilead's demonstration of safety and efficacy.
But Dr. Michelle Estrella of Johns Hopkins University School of Medicine, the panel's lone 'no' vote, said data on potential renal problems and women's health was too limited to justify her approval.
"There are plenty of alternatives to Quad," she said. "There's no huge hurry in approving this drug before the outstanding studies are completed."
Most of Gilead's current drug sales, which totaled $8.1 billion last year, come from Atripla, a once-daily pill that combines Truvada with Bristol-Myers Squibb's Sustiva. Truvada consists of Gilead's older HIV drugs Emtriva and Viread.
Nearly 1.2 million Americans are infected with the human immunodeficiency virus that causes AIDS and the HIV epidemic grows by 50,000 new cases each year, according to the U.S. Centers for Disease Control and Prevention.
Company research shows Quad to be 88 percent effective at suppressing HIV infection, surpassing 84 percent efficacy for Atripla. But data also indicated a disproportionate number of kidney problems among the hundreds of patients who participated in clinical trials.
If approved by the FDA, Gilead executives said Quad would provide HIV suffers with the first ever once-daily integrase inhibitor, a class of drug designed to block the spread of HIV by preventing the virus from binding with the DNA of host cells.
Advocates said the one-a-day regimen would encourage patients to adhere to the treatment with Quad, boosting the likelihood of high efficacy outside the clinical atmosphere.
But HIV activists who provided public testimony warned policymakers to be wary of new HIV drugs that provide only marginal improvements over current treatments but allow drug makers to charge significantly higher prices at a time when public assistance can be restricted by government budget constraints.
"Reduced access here in America is compelling AIDS activists to rethink the rules on drug pricing," said James Driscoll of the AIDS Healthcare Foundation, a Los Angeles-based nonprofit group that provides care for nearly 170,000 HIV and AIDS patients.
Gilead said it has yet to establish a price for Quad. Atripla currently costs about $20,000 a year.
Sign Up for Free Newsletters
Ask Your Doctor the RIGHT Questions!
the most from your doctor visit.
Emailed right to you!
The Ask Your Doctor email series
may contain sponsored content.
18+, US residents only please.
Get the MOST from QualityHealth
- Top Searches
- 1. Arthritis Management: Nature Heals
- 2. 5 Digestive To-Dos
- 3. Men: Should You Shave It or Leave It?
- 4. Today's Top Fitness Trends
- 5. Sugar and Osteoarthritis : The Link
- 6. Can't Afford Your Hospital Bills?
- 7. Stay Energized All Day Long
- 8. Phobias: Who Has Them and Why?
- 9. What If Your EpiPen Fails?
- 10. 5 Costly Medical Billing Mistakes
- 1. Ice Falls Can Cause Serious Injuries
- 2. Can Inactivity Act Like a Disease?
- 3. Kale Snack Recipe for Diabetics
- 4. How Running Affects Arthritis
- 5. Sugar and Your Immunity System
- 6. Do Weight Loss Supplements Work?
- 7. 5 Super Foods for Spring
- 8. The Hazards of Reusable Bags
- 9. How to Avoid Ingrown Hairs
- 10. Health Tip: Constantly Change Shoes
- 1. 4 Common Treatments for Epilepsy
- 2. What Does a Urogynecologist Do?
- 3. GERD Without Heartburn? It's Possible
- 4. Graston Technique: Can It Work on You?
- 5. Music Therapy Can Help Autism
- 6. 8 Ways to Fight MS-Related Fatigue
- 7. Can You Still Bleed After Menopause?
- 8. Be Your Own Health Care Advocate
- 9. Why Is Syphillis on the Rise?
- 10. Ideal Weight vs. Happy Weight
The material on the QualityHealth Web site is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a physician or other qualified health provider. See additional information.