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D.C. Week: FDA Okays Single-Pill Tx for HIV

D.C. Week: FDA Okays Single-Pill Tx for HIV

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WASHINGTON — The FDA approved a new two-drug combo for certain HIV patients, as well as the first epinephrine auto-injector for infants.

FDA Gives Nod to Two-Drug HIV Combo

For some people with HIV, the long-established three-drug treatment paradigm has been upset, with FDA approval of a new single-pill regimen that contains only two medications.

But the combination of dolutegravir (Tivicay), and rilpivirine (Edurant) — to be marketed as Juluca — isn’t for everyone, the FDA cautioned. Only patients whose infection has been suppressed for at least 6 months on a standard three-drug regimen — and who have neither a history of treatment failure nor any HIV mutations associated with resistance to either dolutegravir or rilpivirine — will be eligible to use the new combination.

“Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients,” Debra Birnkrant, MD, of the FDA Center for Drug Evaluation and Research, said in a statement announcing the approval.

Opioids: FDA Issues New Guidance

The FDA on Tuesday issued a final guidance document to help companies develop generic versions of approved abuse-deterrent opioids.

FDA Commissioner Scott Gottlieb, MD, said in a statement that the guidance was “one piece of the FDA’s ongoing work aimed at finding solutions to combat the opioid crisis.”

Although the agency would ultimately like to reduce the number of people addicted to opioids by decreasing exposure to them, “we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives,” said Gottlieb. “Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.”

The FDA has so far approved 10 abuse-deterrent opioid formulations, but uptake has been slow, he noted. “The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions.”

Less Waste Means Better Healthcare, Expert Advises

Eliminating waste in the healthcare system to curb healthcare costs is truly possible, a health policy expert advised.

“The United States has spent $3.4 trillion dollars on care delivery, and I’m suggesting that half of that is recoverable waste, potentially,” said Brent James, MD, senior fellow at the Institute for Healthcare Improvement, and former Chief Quality Officer of Intermountain Health, in a talk at the American Enterprise Institute on Monday.

James, a contributor to the “To Err is Human: Building a Safer Health System” from the National Academies of Sciences, Engineering, and Medicine, argued that “any competent care delivery team” needs to focus on eliminating waste in the healthcare system. He said the rewards of such a strategy are “dramatically higher” than more traditional revenue enhancement strategies, such as increasing the volume of laboratory tests and scans.

FDA OKs Epinephrine Auto-Injector for Small Children

The FDA has approved the first epinephrine auto-injector specifically designed for infants and small children weighing 16.5 to 33 lbs, Kaléo, the device’s manufacturer, announced Monday.

The AUVI-Q 0.1 mg device is “specifically designed for the treatment of life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5 to 33 lbs (7.5 to 15 kg) who are at risk for or have a history of serious allergic reactions,” the company said in a press release.

“Until now, healthcare practitioners and caregivers to infants and small children have not had an epinephrine auto-injector with an appropriate dose of epinephrine available to them, potentially causing some delay in the administration of epinephrine in a life-threatening allergic emergency,” said Vivian Hernandez-Trujillo, MD, a pediatric allergist at Nicklaus Children’s Hospital in Miami, in the release.

“Having an epinephrine auto-injector with a needle length and dose specifically designed for infants and small children should help alleviate concerns around hitting the bone or injecting too much epinephrine.”

Next Week

The Coalition to Transform Advanced Care (C-TAC) will host the National Summit on Advanced Illness Care from Monday to Wednesday.

On Tuesday, the House Committee on Oversight and Government Reform will explore strategies for fighting the opioid crisis at a field hearing in Baltimore.

On Wednesday, the Senate Help, Education, Labor, and Pensions (HELP) Committee will discuss the nomination of Alex Azar to lead the U.S. Department of Health and Human Services.

On Thursday, the Senate HELP Committee will hear from government and medical experts on the front lines of the opioid epidemic. And a subcommittee for the House Committee on Energy & Commerce will examine the impact of the 21st Century Cures Act.

Also, Health Affairs will host a discussion on workplace satisfaction among physicians.

On Thursday and Friday, the FDA’s Blood Products Advisory Committee will discuss “bacterial risk control strategies for blood collection establishments and transfusion services.”

On Friday, the Alliance for Health Policy will discuss the future of Medicare payment.


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