Showing posts with label HIV Meds. Show all posts
Showing posts with label HIV Meds. Show all posts

August 5, 2019

A Penny Size Implant is on the Pipe to Prevent HIV for a Year


In what could eventually become a milestone for H.I.V. prevention, very preliminary tests of an implant containing a new drug suggest that it may protect against infection for a full year.

The new implant, by the drug company Merck, was tested in just a dozen subjects for 12 weeks. But experts were quite excited at its potential to revolutionize the long battle against H.I.V.

The research was described on Tuesday at an international AIDS conference in Mexico City.

New H.I.V. prevention methods are desperately needed. About 75 million people have contracted the lethal virus since the AIDS epidemic began. Even now, about 1.7 million people are infected each year — despite decades of promotion of condoms and abstinence, and years of efforts to get people to take a daily pill that prevents infection.

“If — and I’m emphasizing if — if it pans out in a larger trial that it delivers a level of drug that’s protective for a year, that would be a game-changer,” said Dr. Anthony S. Fauci, director of the National Institute for Allergy and Infectious Disease and a leading expert on AIDS.

Dr. Robert M. Grant, a researcher at the University of California, San Francisco, who led the landmark 2010 trial that proved that a daily pill could thwart H.I.V., said he had expected a breakthrough based on the powerful new drug used in the implant.

The device “seems ideal in many respects,” he added. “It can be removed if there are side effects or H.I.V. infection.”

Merck’s innovation is to deliver its new antiretroviral drug, islatravir, with a proven technology long used for birth control: a matchstick-sized plastic rod inserted just under the skin of the upper arm that slowly releases tiny doses of the medication.

Many people at risk of H.I.V. infection, particularly women in Africa, are desperate for prevention methods that are easier to use, and easier to conceal, than a bottle of pills.

According to Unaids, more than 6,000 young women under age 24 are infected every week, and 80 percent of infected teenagers in Africa are girls. 

African girls are often victims of rape or pressured into sex with older men in return for food, clothes or cash.

Another study released Tuesday at the same conference reinforced the extreme vulnerability of young African women.

In it, 427 women and teenage girls in South Africa and Zimbabwe were given Truvada pills, the form of so-called pre-exposure prophylaxis to prevent H.I.V. infection, also called PrEP, used in the United States.

They were repeatedly reminded to take the pills every day, but after one year, blood tests showed that less than a third were still taking any pills. Only 9 percent of the women and girls took them frequently enough to have protective levels of the drug in their bloodstreams.

The study’s authors are still interviewing participants about why they failed to comply. But women in Africa often say they cannot keep H.I.V. drugs at home because they fear being accused by family, neighbors and lovers of being immoral or of having H.I.V. Some fear being threatened or beaten.

(Clinical trials among women in Africa often fail, or produce hard-to-interpret results, because some participants sign up but rarely use the interventions being tested. In interviews afterward, some have admitted to joining only because the trials offer free medical care and modest payments for participating.)

The drug used in the new implants is islatravir (pronounced IZ-lah-trah-veer), which until last week was known as EFdA or MK-8591. It is the first in a new class of drugs called nucleoside reverse transcriptase translocation inhibitors, which block movement of the enzyme responsible for cloning the virus’s DNA so that it can infect new cells. 

Islatravir has “some remarkable attributes,” said Dr. Roy D. Baynes, Merck’s chief medical officer.

It is 10 times as potent as any previous H.I.V. drug, he said, so tiny amounts are effective, which lowers the risk of side effects. The drug lingers in the body for a relatively long time — after five days, half of the dose remains — so it can be given less often that other H.I.V. medications.

Unlike some H.I.V. drugs, islatravir is absorbed into anal and genital tissues, which is where most infections start. And because it attacks a different step in the infection process, the drug appears not to give rise to viral strains with cross-resistance to other H.I.V. drugs.

Other drug companies have recently reported success with other long-acting forms of H.I.V. prevention. For example, injections of cabotegravir or rilpivirine deep into the buttocks have protected study participants for a month.

But monthly intramuscular injections are inconvenient and sometimes painful. And implants can be removed. The half-life of injectable cabotegravir, for example, is about 40 days. If a user develops a “breakthrough” H.I.V. infection in spite of the injection, the lingering drug may drive the virus to mutate into a resistant form.

Although scientists are excited about the Merck implant’s possibilities, they warned that it still needs to prove itself.

The drug has protected rats and monkeys against multiple deliberate attempts to infect them, but human testing thus far has been only for safety: to see whether a handful of people could tolerate the implant for three months without dangerous side effects.

The assumption that the implant could protect against H.I.V. for a year was arrived at by estimating how much drug is considered protective and how much the implant can hold. A real-world test will mean giving the implant to thousands of sexually active or drug-using men and women, and tracking how many get infected. 

Such a trial will be long and expensive, said Mitchell J. Warren, executive director of AVAC, an advocacy group for H.I.V. prevention.

Participants cannot just be given the implant and told to go out and have sex or inject drugs. Ethically, they must be offered the best prevention methods available, including oral PrEP, condoms, clean syringes and intensive counseling about safe sex or safe drug use.

That means many subjects must be followed for years to see if the implant works better than other methods. 

Dr. Baynes, of Merck, declined to discuss how the next trial would be designed or to speculate on how long it would take. The company, he said, would consider testing in both the United States, where most H.I.V. transmission is between gay men, and in Africa, where the virus is passed mostly between men and women.

He also declined to discuss the eventual cost, other than to say “we’re committed to responsible pricing.”

Price is a deeply contentious issue in PrEP. High hopes for a quick end to the AIDS epidemic raised by Dr. Grant’s 2010 study were dashed after relatively few Americans began taking Truvada — in part because Gilead, the patent-holder, raised the price to $20,000 a year and sued every generic competitor that tried to enter the market.

Other research groups have begun testing similar subdermal implants for H.I.V. prevention, such as one that contains a new form of tenofovir, the main drug in Truvada.

High prices for prevention methods have been a constant disappointment, Dr. Grant said: “There is always a bright shiny new object with people asking, ‘Who cares what it costs?’”

Donald G. McNeil Jr. is a science reporter covering epidemics and diseases of the world’s poor. He joined The Times in 1976, and has reported from 60 countries. 


September 26, 2018

Britain's Outperforms and is Cheaper than US on HIV Drugs-- Why Is That?

Britain’s National Health Service far outperforms America’s health care system — for far less money — at keeping H.I.V. patients healthy.

By Tina Rosenberg
Ms. Rosenberg is a co-founder of the Solutions Journalism Network, which supports rigorous reporting about responses to social problems.  

Justin Sullivan/Getty Images  Last week, the High Court of England and Wales announced a momentous decision: It invalidated the pharmaceutical company Gilead’s patent on Truvada, opening the way to generic competition.

Truvada, a combination of two drugs, is one of the world’s most-used H.I.V. medicines. For treating H.I.V., it’s used along with a third drug. But many H.I.V.-negative people also take Truvada daily as a preventive. That’s called pre-exposure prophylaxis, or PrEP.
In the United States, Truvada is available only as a brand-name drug. It costs $20,000 a year.

Here’s how it will work in Britain’s National Health Service, according to Dr. Andrew Hill, a senior research fellow at Liverpool University who studies the cost of medicines. “The N.H.S. will say to a group of generic companies: ‘We need PrEP for 20,000 people. Give us your best price.’” The cost of making PrEP is $55 per year, Dr. Hill said. He believes that the generic will sell for between $100 and $200.

All over the world, more and more people are taking H.I.V. drugs. These medicines are very good at their job — keeping people healthy and noncontagious — so most patients will take them until they die of something that isn’t H.I.V. Patients are also starting earlier on antiretroviral therapy; the new recommendation is to start immediately upon diagnosis. And now with PrEP, a potentially enormous new group of patients has arisen: H.I.V.-negative people who are at risk for catching the virus. 

ion for the same amount or less money each year. England’s region of the health service spends about half a billion dollars per year on H.I.V. drugs. There are no increases for inflation, and lots of pressures for further cuts.

It’s lucky, then, that Truvada will have generic competition. It should allow the health service to greatly lower costs and offer PrEP to anyone who needs it.
The health service does an admirable job with H.I.V. Around the world, countries measure the percentage of people living with H.I.V. who have no virus detectable in their blood. In the United States, only 49 percent have achieved this. In Britain, the number is 78 percent.

While the National Health Service has a lot of problems, it has some huge advantages over the American system that allow it to provide high-quality H.I.V. care in a cost-efficient manner.

So it’s worth looking at what the British health service does right, because some of those strategies could work in America, even though the two systems are structured very differently.  

About the American health care system’s indifference to cost. There’s virtually no one in the system with the incentive, responsibility or power to lower the astronomical cost of H.I.V. drugs. Panels that establish guidelines recommend, and doctors tend to use, the newest drugs, even if they offer little benefit over existing ones. Patients are content because manufacturers help them with co-pays for expensive drugs. Generics are almost never used.

This year, the generic company Mylan introduced some lower-cost medicines. They are still not cheap; Mylan’s equivalent of Truvada costs $12,000 a year. Still, the creation of these new drugs has inspired a few experimental attempts to substitute them for equivalents that are even more expensive.

Even when brand-name drugs have no generic equivalents, the medicines in the British system cost a small fraction of what they cost in America. Most brand-name triple therapies cost about $6,500, said Dr. Laura Waters, an H.I.V. physician who is a member of the health service’s H.I.V. Clinical Reference Group, which sets policy. She said that a combination pill that includes some generics would cost between $2,600 and $4,000. Full generics usually cost 70 to 80 percent less than comparable brand names. One completely generic H.I.V. regimen costs $400 per year.

The National Health Service has long relied on generics to treat most diseases. But that wasn’t the case with H.I.V. Once effective drugs were developed, the field moved so fast that by the time a drug went off patent, it was no longer commonly prescribed.

But that’s not true anymore.
The first H.I.V. therapies, in 1995, were lifesaving — and toxic, with horrible side effects. Some of them required patients to take 20 pills a day.

Now patients around the world take one or two pills a day. All the regimens do well at controlling the virus. They all have some side effects for some people, but patients can switch to find a regimen they can tolerate well. What used to be a big leap forward with each new drug is now a tiny step — or an advance for only a subset of patients. So older drugs are still in use. Truvada is one example.

Three years ago, the National Health Service’s push for generics started to cover H.I.V. drugs. Dr. Waters estimated that at the time, fewer than 5 percent of H.I.V. patients were taking a generic. Now, she said, the number is more like 30 percent. 

August 29, 2018

HIV+ Man Charged with Not Taking HIV Meds

                                                   Image result for hiv meds               

Authorities have taken the unprecedented step of charging a Vancouver man under the province's Public Health Act for allegedly refusing to comply with a medical health officer's orders for HIV treatment.
Vancouver's medical director of communicable disease control told CBC News the issuing of an order is rare enough in itself. But the case is the first time her office has resorted to the courts for enforcement. 
"I cannot impress upon you to what extent this is an unusual step for us to take. This is not the norm," said Dr. Reka Gustafson.
"One of the worst outcomes of taking this step is that the public mistakenly gets the impression that something like this can happen to them either easily or that there isn't due process or fairness or ethics."

'Criminal prosecution is not appropriate'

CBC News has decided not to publish the 34-year-old man's name.
His lawyer sought a publication ban Wednesday on details of a hearing held last month resulting in the man's release on $500 bail and four conditions that include complying with Gustafson's orders.
According to a court document sworn in June, the four Public Health Act charges concern a nine-month period from August 2017 until this April. Vancouver Coastal Health medical officer Dr. Reka Gustafson said the case is the first time her office has ever gone to the courts under the Public Health Act to force someone to comply with an order. (CBC)
The man is accused of failing to collect medication and failing to attend clinic appointments, the document says.
The court document says the order was tied to the level of human immunodeficiency genetic material in his blood: once it exceeded a level that would make him infectious he was supposed to attend daily appointments.
Gustafson would not comment on the specifics of the case itself, but stressed that the charges were sworn under legislation designed to protect public health as opposed to the Criminal Code.
"Criminal prosecution is not appropriate for HIV," she said. "It's not appropriate for communicable diseases — period. It's not appropriate; it's not effective."

Intervening when HIV/AIDS a risk to others

The B.C. Centre for Disease Control published guidelines last summer for medical health officers considering intervention when people with HIV/AIDS pose a risk of harm to others.
The document was designed primarily for situations where people diagnosed with HIV engage in high risk sexual behaviour or share needles or drug paraphernalia without informing others about their infection and the related risk.
Tests and treatment for HIV have drastically improved the lives of people with the virus and helped to combat the stigma once associated with HIV and AIDS. (Ron Boileau/CBC)
It says people with a "viral load" less than the level cited in the charging document have "a negligible risk of transmitting HIV to their sexual partners."
​Gustafson said she has directly managed the public health management of 2,000 cases of HIV in the past decade, working with clinicians and agencies to develop plans for treatment and support.
Her office has only issued a handful of orders. But they have never before sought the help of the courts to force someone to comply.
"You don't take a step like this lightly or without consultation with colleagues, with individuals who would have concerns about taking this step," she said.
"The order wouldn't be very meaningful if you weren't able to enforce that order with potential support of the courts."
According to the centre for disease control's guidelines, the issuing of an order can be considered if a medical health officer "reasonably believes that the person continues to pose a risk of harm to others, and voluntary and other measures have been exhausted."
The document says medical health officers should discuss the use of such measures with the provincial health officer and legal counsel. Gustafson said she also consulted ethicists and other clinicians.

'Testing works … treatment works'

Potential penalties for conviction under the relevant section of the Public Health Act include fines of up to $25,000 and imprisonment for up to six months.
Gustafson said her office's aim would be that "the person would be required by the courts to take whatever prevention measures would be needed to reduce the probability of transmission." 
​She said the past decade has seen great success in tackling both the stigma around HIV and the rate of new infections.
She also pointed to the province's decision as of last January to cover prophylactic medication, which effectively acts as a vaccine for people who fear they may be at risk of exposure to HIV.
"There has been a steady decline in new HIV infections because testing works, because treatment works, because of supporting people to live with their infection which is now a chronic manageable condition," she said.
Gustafson said the public should know that any decision to go to court would not be taken lightly.
"The last thing we want is for people to get the impression that this happens often or that it can happen easily and that it makes them feel unsafe to be diagnosed and treated," she said.
"So what's at stake is the potential undermining of the measures that we know are very, very effective at a population level based on a very, very uncommon occurrence."
  Jason Proctor · CBC News 

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