Don’t Use Pricey New HIV PrEP Drug When Generics Available: Study

News Picture: Don't Use Pricey New HIV PrEP Drug When Generics Available: Study

MONDAY, March 9, 2020 (HealthDay News) — The creation of HIV-suppressing medication has ushered in a brand new period of “pre-exposure prophylaxis” (PrEP) that drastically cuts a sexually energetic individual’s odds of contracting the virus.

But wider entry to PrEP is being threatened by pharmaceutical firm efforts to curb using low cost, new generic types of these medicines, researchers argue in a brand new research.

The research authors stated that their evaluation discovered that an costly new branded formulation of PrEP — touted as being safer by the corporate that makes it — would in actuality be no higher than cheaper generics.

Also, any push to make use of brand-name PrEP might sluggish efforts to finish the HIV epidemic, the researchers contend.

If the brand new branded drug “succeeds in driving out its generic competitor, PrEP enlargement within the U.S. might grind to a halt and the brand new drug might find yourself inflicting extra avoidable HIV transmissions than it prevents,” stated research senior creator A. David Paltiel. He’s professor of public well being on the Yale School of Public Health, in New Haven, Conn.

HIV PrEP is a capsule taken as soon as a day that reduces the danger of HIV an infection by way of intercourse or injection drug use by as much as 99%.

However, since 2012, there has solely been one U.S. Food and Drug Administration-approved PrEP. It’s a mixture of tenofovir/emtricitabine (F/TDF) that is been marketed by Gilead Sciences and bought below the model title Truvada.

Patent safety for Truvada is because of expire and the primary generic model is anticipated in September 2020, Paltiel’s staff stated.

Is newer drug safer?

Truvada does have “a robust report of security and efficacy,” stated research co-author Tim Horn, in a Yale information launch. He directs remedy entry and pricing for the National Alliance of State & Territorial AIDS Directors.

But brand-name medication are usually way more costly than generics. So, “the upcoming arrival of a far cheaper, equally secure and efficient, generic various is a golden alternative to develop entry to PrEP in among the most difficult-to-reach segments of the at-risk inhabitants,” Horn believes.

However, in October the FDA accepted a new type of PrEP, known as Descovy, additionally made by Gilead. It’s a barely completely different drug combo: emtricitabine/tenofovir alafenamide (F/TAF).

Gilead has been actively recommending that medical doctors who deal with HIV swap sufferers to Descovy, claiming that it is significantly safer than Truvada for sufferers’ bones and kidneys.

But is that declare true?

To discover out, the analysis staff examined whether or not there was proof to justify the frenzy to get sufferers to modify to Descovy — as an alternative of merely utilizing generic types of the outdated Truvada formulation.

The reply: “Even after we forged branded F/TAF in essentially the most favorable gentle doable, we discovered no believable state of affairs below which F/TAF can be cost-effective in comparison with generic F/TDF, besides maybe for the vanishingly small variety of individuals with exceptionally excessive danger of bone or renal [kidney] illness,” research lead creator Dr. Rochelle Walensky stated within the information launch. She’s chief of infectious ailments on the Massachusetts General Hospital and a professor on the Harvard Medical School in Boston.

Paltiel agreed. “In the presence of a generic F/TDF choice, branded F/TAF’s value can’t be justified by its modest advantages,” he stated.

Talk together with your physician

One professional in HIV care stated the research did have some flaws, however agreed that sticking to the generic, as soon as it turns into obtainable, can be the higher choice for a lot of sufferers.

“Clinicians are subjected to typically intense promotional exercise generated each by educational and business pursuits when new medicines and information are generated,” defined Dr. Joseph McGowan, medical director of the Northwell Health HIV Service Line Program, in Manhasset, N.Y.

Often, it is robust for busy medical doctors to separate pharmaceutical firm hype from any actual and documented profit, he stated, so out of expediency they might prescribe the brand new and costly drug.

McGowan stated the brand new evaluation has some shortcomings — for instance, the authors put the projected value of a generic PrEP at 50% lower than brand-name choices, though at this time limit the precise value for sufferers in September is unsure.

But McGowan, who had no position within the new research, stated that the researchers make some necessary factors.

For instance, “in accordance with AIDSVu, virtually two-thirds of PrEP customers fall between the ages of 25 and 44 years, which might be a gaggle anticipated to be at low danger for renal and bone illness,” McGowan stated.

He believes that Descovy would possibly nonetheless be the higher, more cost effective choice for some sufferers over the age of 55, as a result of their dangers for bone and kidney issues is larger.


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On the opposite hand, most Truvada customers (and those that would possibly swap to the generic) solely use the medication throughout “durations of danger” (for instance, sexual exercise) and never on a power foundation, McGowan famous. That might scale back sufferers’ potential for bone or kidney unintended effects, he stated.

His recommendation: Patients ought to speak with their physicians in regards to the professionals and cons of switching from Truvada to both a generic or Descovy.

“Sometimes the shiny new object might not at all times be the higher choice and ought to be used judiciously when there’s a clear profit,” McGowan stated.

HealthDay’s efforts to achieve out to Gilead for remark had been unsuccessful.

The research was printed March 9 within the journal Annals of Internal Medicine.

— E.J. Mundell

Copyright © 2020 HealthDay. All rights reserved.

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SOURCES: Joseph McGowan, M.D., medical director, Northwell Health HIV Service Line Program, Manhasset, N.Y.; Yale School of Public Health, information launch, March 9, 2020

After Tooth Pull, Opioids Don’t Relieve Pain Better Than Other Meds: Study

News Picture: After Tooth Pull, Opioids Don't Relieve Pain Better Than Other Meds: Study

FRIDAY, March 13, 2020 (HealthDay News) — Opioids are not any higher than different meds at quelling the ache of a pulled tooth, a brand new examine finds, suggesting it could be potential to considerably scale back their use in dentistry.

University of Michigan researchers requested greater than 325 individuals who had enamel pulled to charge their ache and satisfaction inside six months of their extraction.

About half of those that had surgical extraction and 39% of those that had routine extraction had been prescribed opioids, in line with the examine.

“Patient satisfaction with ache administration was no totally different between the opioid group and non-opioid group, and it did not make a distinction whether or not it was surgical or routine extraction,” examine co-author Dr. Romesh Nalliah mentioned in a college information launch. He is affiliate dean for affected person companies at Michigan’s School of Dentistry.

In truth, his group was stunned to seek out that sufferers who received opioids reported worse ache than these given non-opioid painkillers for each sorts of extractions.

The examine additionally discovered that about half of the opioids prescribed went unused.

If leftovers aren’t disposed of correctly, sufferers or individuals round them might be liable to future opioid misuse, the researchers famous.

“The real-world information from this examine reinforces the beforehand printed randomized-controlled trials displaying opioids are not any higher than acetaminophen and nonsteroidal anti-inflammatory medication for ache after dental extraction,” mentioned examine co-author Dr. Chad Brummett. He’s director of the Division of Pain Research at Michigan Medicine.

The authors mentioned their findings counsel that main modifications are wanted in dental prescribing practices in gentle of the present opioid disaster within the United States.

The American Dental Association suggests limiting opioid prescriptions to seven days’ provide, however Nalliah thinks that is an excessive amount of.

“I feel we are able to nearly eradicate opioid prescribing from dental apply,” he mentioned. “Of course, there are going to be some exceptions, like sufferers who cannot tolerate nonsteroidal anti-inflammatories. I might estimate we are able to scale back opioid prescribing to about 10% of what we at present prescribe as a career.”

The examine was printed March 13 within the journal JAMA Network Open.

— Robert Preidt

Copyright © 2020 HealthDay. All rights reserved.


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SOURCE: University of Michigan, information launch, March 13, 2020