Tag Archives: gilead

The FDA have approved another ‘Next-Gen’ Gilead HIV Drug


The FDA on Monday approved the latest combo HIV combo therapy from Gilead Sciences: Descovy.

Story via Fortune

The therapy improves upon existing Gilead HIV medicine: Viread, according to the company, because it contains a newer formulation of a key ingredient called tenofovir. That will allow Descovy to be delivered to patients at lower doses, potentially foretelling fewer negative side effects.

Gilead spokespeople described the therapy as “the first new HIV treatment backbone” approved in more than a decade. “Descovy represents an important evolution in HIV care,” said Chief Scientific Officer Norbert Bischofberger. “As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”

The California-based drugmaker has racked up a series of new HIV approvals in recent months, including Genvoya and Odefsey.

But some of these have been met with patient advocate criticism. Last autumn, the AIDS Healthcare Foundation alleged that Genvoya’s approval amounted to an attempt by Gilead to evergreen its patents on the older HIV med Stribilid, since the two drugs are essentially identical other than Genvoya’s newer tenofovir formulation.

Between HIV/AIDS therapies and Gilead’s hepatitis C treatments Sovaldi and Harvoni, the firm’s antiviral franchise brought in more than $30 billion in global 2015 sales.

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Hepatitis C drug delayed by NHS due to high cost

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. Photograph: Bsip/UIG via Getty Images

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. Photograph: Bsip/UIG via Getty Images

The NHS is to delay the introduction of a highly expensive drug that can save the lives of people infected with the hepatitis C virus. The move by NHS England is unprecedented, because the NHS rationing body, Nice (the National Institute for Health and Care Excellence) has approved the drug. Nice says sofosbuvir is cost-effective, because it is a cure for people who would otherwise run up huge NHS bills.

One in three people infected with hepatitis C will develop liver cirrhosis and some will get cancer. A liver transplant costs more than £50,000.

But NHS England appears to be balking at the bill for the drug, which would hit £1bn for every 20,000 people treated. Approximately 160,000 people in England alone are infected with hepatitis C, although fewer than half are aware of it.

Sofosbuvir has been hailed internationally as a breakthrough, but there is global concern over the very high cost of a drug that can save lives. Campaigners are pressing for lower prices, from the US – where it costs $1,000 a pill – to India, in a fight which they liken to that over drugs against another virus: HIV, which causes Aids. On Wednesday, they celebrated a decision by the Indian authorities not to allow a patent application for sofosbuvir by Gilead, the manufacturer, which means Indian companies may be able to make cheap copies for the developing world.

The price offered by Gilead in the UK is almost £35,000 for a 12-week course. Many patients will need a 24-week course, costing £70,000. In its final draft guidance on sofosbuvir, Nice said it was allowing NHS England to postpone implementation for four months, until the end of July instead the beginning of April. NHS England failed to comment.

Charles Gore, chief executive of the Hepatitis C Trust, said he was very concerned about the delay. Nice had allowed NHS England to make a decision based on affordability rather than cost-effectiveness. “It feels to me as if a whole new criterion has been invented by the backdoor,” he said. If the NHS could delay using a new drug by four months, it could also delay by six months or a year – or it could decide on the basis of its cash-strapped budget to use it one year but not the next.

“It is undoubtedly a high cost,” said Gore. “The unfortunate thing is there are an awful lot of people who need it. We’re talking about potentially hundreds of thousands of people. That becomes a massive budget-buster.”

NHS England has introduced a scheme to pay for the treatment of people who are very ill – many of them on liver transplant waiting lists. In April, it announced an £18.7m fund to pay for 500 patients with acute liver failure.

But Mark Thursz, professor of hepatology at Imperial College London and chair of the Hepatitis C Coalition, said there were others who needed treatment as soon as possible. “The delay is unprecedented,” he said. “What worries me about it is that if you have got advanced liver disease with hepatitis C, you could progress at any stage to the point where it is very difficult or impossible to reverse the situation or have any improvement. Opportunities are being missed by any delay.”

About 10,000 to 15,000 of people with hepatitis C infection in the UK have cirrhosis, he said. Around 5,000 have advanced disease and need treatment soon if they are not to suffer long-term damage.

Hepatitis C is spread by contact with infected blood. Some people live with it unknowingly for years having injected drugs in their youth, while some got it from blood transplants before screening for the virus was introduced. It is also thought to be spread by sharing razors or toothbrushes with those infected.

There are older drugs but the treatment lasts up to four years and has serious side-effects, including depression. Sofosbuvir is a once-daily pill, taken with one or two other drugs for 12 or 24 weeks

Stelios Karagiannoglou, Gilead’s general manager, UK and Ireland, said the company was pleased with the Nice decision. But he added: “We are disappointed that the majority of patients will not gain access to this important medicine until later this year.” He called on NHS England to commit to a scheme from April offering early treatment for people with cirrhosis.

Story via The Guardian

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10 things you need to know about the pill to prevent HIV

The Magic Pill

It’s been called, simultaneously, a medicine to “end the HIV epidemic” and a “party drug:” Pre-exposure prophylaxis, or PrEP for short, refers to a daily antiviral treatment that prevents HIV.

That’s right: People who don’t have the virus can take a pill a day to save themselves from getting infected.

Haven’t heard about PrEP? You’re probably not alone. The drug-maker, Gilead, doesn’t advertise Truvada (its brand name) for prevention, and the Centres for Disease Control and Prevention only endorsed it this past May—two years after it hit the market.

Want to learn more about PrEP, (click here).

Going forward, however, you’ll be hearing a lot more. On Friday, the World Health Organization backed the antiviral, recommending all HIV-negative men who have sex with men consider taking it as part of a strategy to reduce the global incidence of the disease. But there’s a lot more to the story. Here’s what you need to know:

1) Public health officials aren’t recommending this pill for “all gay men,” despite what the headlines say

The pill is “for people who do not have HIV but who are at substantial risk of getting it,” according to CDC guidance. “At substantial risk” means you regularly have unprotected sex with partners of unknown HIV status. This can include men who have sex with men, heterosexual men and women, injection drug users, sex workers, and people in couples with an HIV-positive partner. In other words, not simply “all gay men.”

The latest headlines about Truvada were so misleading that the WHO had to issue a clarification noting that they support PrEP “as an additional choice”—again, not for all men who have sex with men.

“We know from surveillance that condom use is not as high as is necessary to control the epidemic”

2) Truvada is not a condom replacement

Public-health officials are not endorsing Truvada as an alternative to other forms of protection. “We are suggesting that for people who are already not using condoms, we have another option to help protect them from HIV infection,” says the CDC’s Dawn Smith, biomedical interventions implementation officer. “It’s part of being practical and realistic.” So the hope is that those who get prescriptions are folks who just aren’t using anything to protect themselves. “We know from our surveillance systems that condom use is not as high as is necessary to control the epidemic,” Smith added.

3) We don’t yet know exactly how the drug will be used in real life

Still, this public-health message hasn’t stopped some activists and AIDS campaigners from worrying aloud that the pill will undermine traditional advocacy messages about condoms—especially at a time when HIV infections are on the rise among gay men. And the truth is, we don’t yet know what kind of impact PrEP will have on people’s behaviour.

To find out, there are now “demonstration trials” being run around the world. These will look at how Truvada works outside of clinical trials, the impact of non-daily use of the drug, and whether the antiviral encourages more risky sexual behaviour or leads to an increase in other sexually-transmitted infections.

4) We do know Truvada only works effectively when taken every day

A three-year clinical trial of PrEP in HIV-negative men who have sex with men found that users got much more protection when they took the drug every day. Participants who took the drug less than half the time had a 50 percent reduction in HIV acquisition; daily users cut their risk by more than 90 percent. These results have been supported by other studies in a range of populations—from injection-drug users to heterosexual men and women. The trouble is, most people don’t take their medications as their doctors prescribe.

Drug-resistant strains of HIV have emerged when people with acute, undetected infection were given Truvada

5) Truvada can cause drug-resistant HIV infection

Drug-resistant strains of HIV have emerged when people with acute, undetected infection were given PrEP. This means they were positive when they started the medicine, but levels of the virus in their blood were hardly detectable because their infections were so new. They hadn’t made enough antibodies to show up in a test and so they were prescribed the drug anyway.

There’s some question about how serious this risk is for individuals and public health. For now, doctors are asked to confirm the HIV status of patients and to do follow-up and re-testing throughout treatment.

When asked how much of a concern drug resistance is, Smith of the CDC said, “We don’t know yet. That’s one of the things we’ll learn as the first few demonstration projects begin telling us.”

6) Besides that, it’s pretty safe

Though Truvada for the prevention of HIV was only licensed by the Food and Drug Administration in 2012, it was first authorized in 2004 to treat HIV positive patients. That’s right: the same drug used for these two purposes. Since it has been on the market as a treatment for over a decade—with very minimal side effects and harms—doctors are pretty confident in its safety profile for preventative use. There seem to be few side-effects with Truvada for prevention, the most common one being nausea.

People have been slinging the term ‘Truvada whore’ around, and the head of the aids healthcare foundation called the pill a ‘party drug’

7) “Truvada whores” are a thing

Because of the questions about whether PrEP will cause people to have risky sex and ditch condoms, there’s some related stigma in the gay community. People have even been slinging the term “Truvada whore” around, and the head of the AIDS Healthcare Foundation called Truvada a “party drug.” In response, one PrEP activist created a #TruvadaWhore t-shirt campaign to reclaim the word.

Many have pointed out that this divide parallels the early days of the birth control pill and suggestions that the medication would encourage promiscuity.

8) Uptake has been slow—but that’s not the full story

According to data from the drug maker Gilead, by March 2013 there were approximately 1,774 people in the US taking the drug. But it’s important to put this number in context. First of all, these findings were not published and peer-reviewed; they were presented at a scientific conference last year. When studied, we’ll have a better picture of the PrEP landscape and it may look quite different.  Secondly, Truvada has only been on the US market for prevention since 2012, a year after these numbers were gathered. It often takes decades for innovations to penetrate a market, especially in the conservative field of medicine.

9) The drug is expensive

Without insurance, Truvada can cost up to $14,000 a year, according to the CDC. But for most people, it is covered in their insurance programs and there’s only a co-pay. There are also medication assistance programs across the US for the uninsured that will cover the entire cost of the medication.

10)  HIV remains a socio-economic crisis around the world

Globally, men who have sex with men, prisoners, injection-drug users, and sex workers are still the groups most affected by HIV.

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Gilead – Reducing The Cost Of HIV Medication

Gilead Sciences, the leading maker of HIV drugs, is to share intellectual property rights on its medicines in a patent pool designed to make treatments more widely available to the poor.

The California-based group is the first drugmaker to sign up to the new Medicines Patent Pool, whose organizers now expect other major pharmaceutical manufacturers to join the initiative.

Ellen ‘t Hoen, the pool’s executive director, told Reuters she was negotiating terms for similar deals with ViiV Healthcare — a GlaxoSmithKline and Pfizer joint venture — as well as with Bristol-Myers Squibb, Roche, Boehringer Ingelheim and Sequoia Pharmaceuticals.

“This is not just a one-off. The whole field is changing … there will be more to follow,” she said.

Around 33 million people worldwide have the human immunodeficiency virus (HIV) that causes AIDS. Most live in Africa and Asia, where medicines have to be very cheap to allow those who need them to be able to afford them.

The Medicines Patent Pool, launched by the UNITAID health financing system that is funded by a tax on airline tickets, aims to address this problem by creating a system for patent holders to license technology to makers of cheap generics in exchange for modest royalties.

In the case of Gilead, the agreement allows for the production of generic copies of tenofovir, emtricitabine, cobicistat and elvitegravir, as well as a combination of these products in a single HIV pill known as the “Quad.”

Significantly, cobicistat, elvitegravir and the Quad are still in clinical development, and their inclusion in the deal should speed the flow of new treatments in poor countries.

“Through systematic licensing of intellectual property related to HIV products, people in developing countries will have access to low-cost versions of those products almost at the same time that people in rich countries do,” ‘t Hoen said.

Traditionally, patients in developing countries have to wait for years before they can get access to new drugs.


Gilead will receive a 3 percent royalty on generic sales of tenofovir, which is also approved for use in hepatitis B, and 5 percent on the other products.

The licenses will allow for the supply of tenofovir and emtricitabine in 111 countries, for cobicistat in 102 countries, and for elvitegravir and the Quad in 99 countries.

Assuming other companies come on board, the patent pool could save poor countries more than $1 billion a year in drug costs.

But the revenue stream to Gilead and other patent holders is likely to be small, since generic drug prices in Africa could be just 1 or 2 percent of those in high-income countries.

The decision by Gilead and others to work with UNITAID on the new patent pool marks an evolution in thinking by Big Pharma toward the thorny problem of drug access in the developing world.

Ten years ago, the world’s pharmaceutical industry took a very different stance when it sued South Africa over legislation that was passed by former President Nelson Mandela and which favored generics.

That battle proved a public relations disaster, and since then individual companies have struck a series of voluntary licensing deals, allowing generic copies of HIV products on a case-by-case basis.

The patent pool system, however, goes beyond this by providing an effective “one-stop shop” for generic firms to secure rights to manufacture patent-protected drugs.

The U.S. National Institutes of Health became the first organization to sign up to the pool last September. The concept has been harder for some drugmakers to swallow.

ViiV, for example, was initially unwilling to consider pooling its patents — and Abbott Laboratories, Merck & Co and Johnson & Johnson have yet to enter formal negotiations, although ‘t Hoen said her team was now discussing the idea with all three companies.

Original Reporting by Ben Hirschler

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