Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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AIDs Advocates Accuse Gilead of Creating "Unethical" Barriers to Truvada Access

AIDs Advocates Accuse Gilead of Creating "Unethical" Barriers to Truvada Access | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A trio of AIDS advocacy groups is accusing Gilead Sciences (GILD) of drastically limiting a key component of an AIDS prevention treatment in an “unethical” manner that may violate federal guidelines.

 

At issue is a Gilead drug called Truvada, which is combined with one of two other medicines to form nPEP, or non-occupational post-exposure prophylaxis, the term used to describe preventive treatment. Observational studies suggest the combination can reduce the risk of acquiring HIV infection when started within 72 hours of exposure and continued for a month.

 

However, the drug maker has purportedly created barriers to access, according to the advocacy groups. They maintain that, through a patient assistance program, Gilead has limited access to just once in a lifetime, and has also implemented “hardship review criteria” and procedures for obtaining subsequent prescriptions that have not been clearly articulated.

 

“We believe this policy is unethical and incompatible with CDC guidelines and we implore you to immediately end such an unreasonable policy, in favor of a transparent and accommodating policy that ensures unencumbered and streamlined access to nPEP for those vulnerable to HIV infection,” the groups wrote to a Gilead executive in a letter on Thursday.

 

The groups noted that nPEP is believed to be effective if provided within 72 hours, as suggested in CDC guidelines for HIV prevention, but they argued that the access stipulations imposed by Gilead may make it difficult, if not impossible, for someone to obtain treatment. The other drugs combined with Truvada are either Tivicay, which is marketed by ViiV Healthcare, or Isentress, a Merck (MRK) drug.

 

“We’re afraid this policy is overly stringent,” said Tim Horn, who chairs the Fair Pricing Coalition, one of the organizations that, along with Treatment Action Group and the National Alliance of State & Territorial AIDS Directors, wrote Gilead to complain. “We don’t even know what the hardship qualification is in order to obtain treatment.”

 

A Gilead spokesman declined to comment.

 

Further Reading:

  • “Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing”; http://sco.lt/5wgFsn
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Grindr Poll Says 25% of Gay Men Taking Truvada

Grindr Poll Says 25% of Gay Men Taking Truvada | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The gay hookup app Grindr recently surveyed users about Truvadaand found some noteworthy trends. They’re particularly interesting considering the Centers for Disease Control and Prevention said last month that one out of four gay and bisexual men should take the pill.

Among Grindr users who took the survey, more than 25 percent said they were currently taking the pill, which is known as PrEP — short for “pre-exposure prophylaxis.”

More than 55 percent of respondents said they are interested in taking it.

One out of ten respondents said they struggled to get a doctor to prescribe it. Black men, who have a higher rate of H.I.V. infection than the general population, were twice as likely to get pushback from doctors, Grindr found. Some doctors have expressed concerns about the potential long-term side effects of the pill and argued that it could encourage risky behavior that results in other types of infections.

Among respondents, Latino men were the least likely to be taking Truvada.

Physicians don’t appear to be pushing the pill enthusiastically. The majority of those surveyed said they heard about the pill from friends, rather than from a doctor.

Pharma Guy's insight:

Meanwhile, a third of primary care doctors and nurses in the United States have never heard of Truvada. See http://sco.lt/6XYebR Also, read "Gilead, Support Your 'Truvada Whores!'" http://bit.ly/1AGU2ZY 

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Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing

Gilead, Support Your "Truvada Whores!" HIV activists target Gilead for holding back on Truvada marketing | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Gilead Sciences is no stranger to criticism. Consider the years-long outcry over HIV and hep C drug prices. But now the California-based company finds itself in a strange--yet somehow familiar--spotlight. At a time when the pharma industry is drawing fire for marketing its drugs to doctors, Gilead is drawing fire for not marketing enough.


The issue is Truvada, Gilead's HIV treatment that's also approved to prevent infection with the virus. It's the only drug blessed by the FDA for that use. It's backed by the U.S. Centers for Disease Control and Prevention (CDC) for pre-exposure prophylaxis, or PrEP.


But more than two years after that much-publicized approval, a year after the CDC recommended its routine use, few at-risk people are actually taking Truvada. In fact, as Bloomberg reports, only 3,200 Truvada scripts were written for prevention through March 2014.


Gilead "does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP," spokeswoman Cara Miller told the news service.

Pharma Guy's insight:


Gilead, however, needs to go beyond a drug.com website to get the message out. In fact, this sounds like a problem tailor-made for a mass-media (TV and print) direct-to-consumer advertising solution! But Gilead has no plans to advertise Truvada for prophylaxis, even though the FDA approved it for that use back in 2012.

Why not?

Not advertising helps Gilead avoid controversy, but I contend that in this case not advertising is itself controversial considering that Truvada is 99% effective in preventing HIV infection and that based on the "number needed to treat" data, Truvada is FOUR TIMES more likely to save lives than statins, another widely promoted preventive drug regimen (see chart above).

If Gilead decides to advertise Truvada for prophylaxis, I have some recommendations. Find them here.

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High Cost, Lack of DTC Advertising, & Physician Unawareness are Major Factors for Truvada’s Failure

High Cost, Lack of DTC Advertising, & Physician Unawareness are Major Factors for Truvada’s Failure | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Although Truvada was approved as a preventive drug four years ago, less than one-tenth of those who could benefit from it take the drug [Meanwhile, “Grindr Poll Says 25% of Gay Men Taking Truvada”; http://sco.lt/70Mnqb]. The need is greatest among blacks and Latinos, who are disproportionately affected by AIDS, and gay men under 30, whose rates of infection are growing.

 

Also known as PrEP — for post-exposure prophylaxis — the medicine serves as a backstop to other methods of avoiding infection for those who are at high risk. It’s considered one of the most significant advances in the fight against AIDS.

 

Critics questioned the wisdom of giving powerful drugs to healthy people, and worried that access to a preventive drug would encourage promiscuity or lead to a spike in other sexually transmitted diseases by reducing condom use.

 

In 2012, the first year PrEP was on the market, only 6,210 people nationwide started the drug, according to data from Truvada’s maker, Gilead Sciences. By the end of 2015, more than 79,000 people had started PrEP since the regimen was introduced.

 

What’s the problem?

 

Primary care doctors often don’t know enough about PrEP to feel comfortable offering it. [Read, for example, “Lack of DTC Advertising Means Many Doctors Unaware of Truvada, Drug for Preventing H.I.V.”; http://sco.lt/6XYebR ]

 

Another challenge is the commitment required: In addition to taking a daily pill, patients must come back every three months to test for HIV and other sexually transmitted diseases, and to check for kidney problems, an uncommon but serious side effect.

 

And cost can be an obstacle. The list price for the drug is $1,500 a month, although most insurers negotiate discounts.

 

Pharma Guy's insight:

Gilead did not begin direct-to-consumer advertising of Truvada until January, 2016 (http://bit.ly/2bUyr8q - I'm happy to see that Gilead may have followed my recommendations. Find them here: http://bit.ly/1AGU2ZY).

 

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Lack of DTC Advertising Means Many Doctors Unaware of Truvada, Drug for Preventing H.I.V.

Lack of DTC Advertising Means Many Doctors Unaware of Truvada, Drug for Preventing H.I.V. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Even though taking a daily pill can protect almost completely against getting H.I.V., a third of primary care doctors and nurses in the United States have never heard of it, federal health officials said this week.

Taking Truvada daily gives better than 90 percent protection to men at risk of getting H.I.V. from gay sex, and better than 70 percent protection to drug injectors at risk of getting it from sharing syringes, according to the Centers for Disease Control and Prevention.

“Providers play a central role in increasing awareness and uptake of PrEP,” Dr. Eugene McCray, director of the agency’s division of H.I.V. prevention, said, using the acronym for pre-exposure prophylaxis, as the practice of taking the drug for prevention is known.


Truvada is currently the only antiretroviral drug approved by the Food and Drug Administration for PrEP, but its maker, Gilead Sciences, does not advertise it for that purpose.

Pharma Guy's insight:

Back in May, 2014, I asked "Where's the DTC Ads for Prophylactic Use of Truvada?"; http://bit.ly/1AGU2ZY Not advertising helps Gilead avoid controversy. But I contend that in this case not advertising is itself controversial considering that Truvada is 99% effective in preventing HIV infection and that based on the "number needed to treat" data, Truvada is FOUR TIMES more likely to save lives than statins, another widely promoted preventive drug regimen (see chart above).

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NY Gov. Andrew Cuomo Supports Truvada for PrEP

NY Gov. Andrew Cuomo Supports Truvada for PrEP | Pharmaguy's Insights Into Drug Industry News | Scoop.it

New York's governor is backing a new and controversial strategy for reducing the number of new infections in the state.


He has embraced a new and controversial treatment for people at risk of contracting H.I.V. He wants to put more H.I.V.-negative people on Truvada, a drug originally developed to treat those who already have the virus, and which the F.D.A. approved in 2012 as protection against new infections.

This strategy, known as pre-exposure prophylaxis (PrEP), is one of three planks in Governor Cuomo’s broad plan to cut H.I.V. infections, and the most novel one. The other two (testing more people and getting those who test positive to see doctors; getting H.I.V.-positive people to stay in treatment and on medication) are strategies that New York and other states have pursued for decades with varying degrees of success.

Pharma Guy's insight:


But there's a catch. Many AIDS advocates such as the AIDS Healthcare Foundation (AHF) are afraid that widespread use of Truvada to prevent HIV infection will encourage unsafe sex (e.g., sex without condoms) leading to other problems.

AHF also cites survey results that revealed possible adherence problems - such as unwillingness to pay the $60 per month estimated co-pay for the drug and medical tests required as well as fear of side effects.

On the Truvada website, Gilead has answers to these issues -- such as coupons to cover the co-pay costs of the drug and free condoms. 

Gilead, however, needs to go beyond a drug.com website to get the message out. In fact, this sounds like a problem tailor-made for a mass-media (TV and print) direct-to-consumer advertising solution! But Gilead has no plans to advertise Truvada for prophylaxis, even though the FDA approved it for that use back in 2012.

Why not? Read 

Where's the DTC Ads for Prophylactic Use of Truvada?
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