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MONDAY, March 9, 2020 (HealthDay News) — The advent of HIV-suppressing drugs has ushered in a new era of “pre-exposure prophylaxis” (PrEP) that drastically cuts a sexually active person’s odds of contracting the virus.
But wider access to PrEP is being threatened by pharmaceutical company efforts to curb the use of cheap, new generic forms of these medicines, researchers argue in a new study.
The study authors said that their analysis found that an expensive new branded formulation of PrEP — touted as being safer by the company that makes it — would in reality be no better than cheaper generics.
Also, any push to use brand-name PrEP could slow efforts to end the HIV epidemic, the researchers contend.
If the new branded drug “succeeds in driving out its generic competitor, PrEP expansion in the U.S. could grind to a halt and the new drug could end up causing more avoidable HIV transmissions than it prevents,” said study senior author A. David Paltiel. He’s professor of public health at the Yale School of Public Health, in New Haven, Conn.
HIV PrEP is a pill taken once a day that reduces the risk of HIV infection through sex or injection drug use by up to 99%.
However, since 2012, there has only been one U.S. Food and Drug Administration-approved PrEP. It’s a combination of tenofovir/emtricitabine (F/TDF) that’s been marketed by Gilead Sciences and sold under the brand name Truvada.
Patent protection for Truvada is due to expire and the first generic version is expected in September 2020, Paltiel’s team said.
Is newer drug safer?
Truvada does have “a strong record of safety and efficacy,” said study co-author Tim Horn, in a Yale news release. He directs medication access and pricing for the National Alliance of State & Territorial AIDS Directors.
But brand-name drugs are typically much more expensive than generics. So, “the imminent arrival of a far cheaper, equally safe and effective, generic alternative is a golden opportunity to expand access to PrEP in some of the most difficult-to-reach segments of the at-risk population,” Horn believes.
However, in October the FDA approved a new form of PrEP, called Descovy, also made by Gilead. It’s a slightly different drug combo: emtricitabine/tenofovir alafenamide (F/TAF).
Gilead has been actively recommending that doctors who treat HIV switch patients to Descovy, claiming that it’s considerably safer than Truvada for patients’ bones and kidneys.
But is that claim true?
To find out, the research team examined whether there was evidence to justify the rush to get patients to switch to Descovy — instead of simply using generic forms of the old Truvada formulation.
The answer: “Even when we cast branded F/TAF in the most favorable light possible, we found no plausible scenario under which F/TAF would be cost-effective compared to generic F/TDF, except perhaps for the vanishingly small number of persons with exceptionally high risk of bone or renal [kidney] disease,” study lead author Dr. Rochelle Walensky said in the news release. She’s chief of infectious diseases at the Massachusetts General Hospital and a professor at the Harvard Medical School in Boston.
Paltiel agreed. “In the presence of a generic F/TDF option, branded F/TAF’s price cannot be justified by its modest benefits,” he said.
Talk with your doctor
One expert in HIV care said the study did have some flaws, but agreed that sticking to the generic, once it becomes available, would be the better option for many patients.
“Clinicians are subjected to often intense promotional activity generated both by academic and commercial interests when new medications and data are generated,” explained Dr. Joseph McGowan, medical director of the Northwell Health HIV Service Line Program, in Manhasset, N.Y.
Often, it’s tough for busy doctors to separate pharmaceutical company hype from any real and documented benefit, he said, so out of expediency they may prescribe the new and expensive drug.
McGowan said the new analysis has some shortcomings — for example, the authors put the projected cost of a generic PrEP at 50% less than brand-name options, although at this point in time the actual price for patients in September is uncertain.
But McGowan, who had no role in the new study, said that the researchers make some important points.
For example, “according to AIDSVu, almost two-thirds of PrEP users fall between the ages of 25 and 44 years, which would be a group expected to be at low risk for renal and bone disease,” McGowan said.
He believes that Descovy might still be the better, more cost-effective option for some patients over the age of 55, because their risks for bone and kidney complications is higher.
On the other hand, most Truvada users (and those who might switch to the generic) only use the drugs during “periods of risk” (for example, sexual activity) and not on a chronic basis, McGowan noted. That could reduce patients’ potential for bone or kidney side effects, he said.
His advice: Patients should talk with their physicians about the pros and cons of switching from Truvada to either a generic or Descovy.
“Sometimes the shiny new object may not always be the better option and should be used judiciously when there is a clear benefit,” McGowan said.
HealthDay’s efforts to reach out to Gilead for comment were unsuccessful.
The study was published March 9 in the journal Annals of Internal Medicine.
— E.J. Mundell
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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, news release, March 9, 2020