Tag Archives: Truvada

(Scotland): Decision due on ‘game-changer’ Prep HIV drug

Medical chiefs in Scotland are due to announce whether a “game-changing” drug which can prevent HIV infection will be made available on the NHS.

(Story via BBC)

Research suggests a daily dose of a drug known as Prep can protect people at risk of contracting the virus.

HIV Scotland said it was “very hopeful” the Scottish Medicines Consortium (SMC) would approve the medication.

It means Scotland would become the first place in the UK to make it available on the NHS.

Campaigners estimate that up to 1,900 people north of the border could benefit from the drug, which has the brand name Truvada.

The anti-retroviral drug is currently licensed for use in Scotland, where it is used by people already diagnosed with HIV.

However, the SMC’s decision relates to its use on a preventative basis by people who do not have the virus.

What does Prep do?

Pre-exposure prophylaxis (or Prep for short) is a small, blue pill.

The pill works by protecting cells in the body and disabling the virus to stop it multiplying – should it enter the body.

Taking it once a day has been found to reduce the risk of HIV infection by 86%.

It is currently used in the US, Canada, Australia and France to help protect gay men at the highest risk of contracting HIV.


There is a growing demand for the treatment in Scotland, according to HIV Scotland’s chief executive George Valiotis.

He estimates that “a couple of dozen” Scots are using variants of the drug after buying generic versions online.

The Scottish government wrote to Gilead, the manufacturer of Truvada, to urge them to make an application to the SMC last year.

It followed a series of legal battles in England over whether the NHS or local authorities should pay for the medication.

The Court of Appeal eventually ruled that NHS England had the power to fund the drug,

The decision did not mean that NHS England had to fund Prep but in December it announced plans for a large scale clinical trial of the drug, expected to involve 10,000 participants over three years.


‘Why I buy Prep online’

Gordon Garioch is one of around “a couple of dozen” people in Scotland thought to be taking Prep regularly.

He told BBC Radio Scotland’s Good Morning Scotland that he was initially prescribed the drug by a private clinic but it was too expensive.

He now spends around £50 a month on a generic form of the drug he purchases from an online pharmacy.

“It gives me reassurance,” he said. “I’ve always been careful.

“My friends have always been careful but for some reason they became positive. So I take this extra reassurance for me to prevent myself becoming positive.”

Asked what the benefits of the decision would be, he replied: “To me personally, obviously it would be the cost.

“But it’s a generation thing as well, to prevent HIV for future generations for people who are not as lucky as myself who can pay for it.”


Speaking on BBC Radio 4’s Today programme, Mr Valiotis, of HIV Scotland, said: “Prep makes good sense. We know that it works. We know that it stops people from getting HIV, and we know that it’s cost-effective.

“And because it’s cost-effective, what that means is that it makes more money available in the long-term on the NHS to treat lots of other things as well.”

Asked if he thought the SMC would approve the drug, he said: “I’m feeling pretty hopeful because the cost-effectiveness is clear, as is the clinical-effectiveness.

“We know this works. I would be surprised if it’s a no but it’s too hard to guess.”

HIV Scotland believes the use of Prep has played a part in reducing the number of HIV infections in Scotland.

The latest figures from Health Protection Scotland show 285 new cases of HIV were reported in 2016, down from an annual average of 359 over the last five years.

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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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PrEP acceptable to UK gay men, studies find

Pre-exposure prophylaxis (PrEP) would be an acceptable HIV prevention strategy for large numbers of gay, bisexual and other men who have sex with men in major UK cities, according to two studies presented to the British HIV Association (BHIVA) conference in Birmingham this week.

The conference also heard details of a small pilot PrEP study, likely to start recruiting later this year.

A cross-sectional survey of 842 HIV-negative gay and bisexual men, recruited at bars, clubs and saunas in London, suggested that half the respondents would be interested in taking PrEP.

Respondents were given information about pre-exposure prophylaxis and asked: “If PrEP were available, how likely is it that you would take a pill (oral dose) on a daily basis to prevent HIV infection?”.

Half said yes, with 16% saying they were likely to take PrEP and 34% saying they were very likely to. Men interested in PrEP were slightly more likely to be under the age of 35 (AOR adjusted odds ratio 1.58), have attended a sexual health clinic in the past year (AOR 1.59) and to have previously taken post-exposure prophylaxis (PEP) (AOR 1.96). After statistical adjustment, various measures of risky sex were no longer associated with interest in PrEP.

In this survey, 17 men (2.1% of those answering the question) said that they had previously taken antiretroviral drugs to reduce their risk of HIV infection.

Secondly, clinicians at the Manchester Centre for Sexual Health surveyed HIV-negative men attending their service who reported unprotected receptive anal intercourse. Of the 121 men who responded, 36% said they would be “very willing” to take PrEP while only 14% said they would not take the treatment. Daily dosing was perceived as a better option by four fifths of respondents – just one fifth would prefer taking a dose before sexual activity.

These data confirm and reinforce findings from a study reported in November 2011, which found that half the gay men surveyed would consider taking PrEP. Once again, daily dosing was preferred to taking a dose before sex. In the qualitative data, men commented that sex is often spontaneous and that they felt daily dosing would facilitate adherence.

However these data are all based on giving men a few key facts about PrEP and presenting it as a hypothetical option. In real-life circumstances, where men think more seriously about PrEP as an option and hear friends’ experience of taking it, actual uptake and sustainability may be very different.

While the Manchester respondents largely assured the researchers that they would take all their doses of PrEP and wouldn’t have more risky sex, real-life experience needs to be tested in research.

To this end, the Medical Research Council are seeking funding for a 5000-participant, two-year study which would randomise HIV-negative gay men who report unprotected anal intercourse to either take PrEP (Truvada) and attend motivational interviewing (intervention group) or to be put on a one-year waiting list for PrEP and to have motivational interviewing in the meantime (control group).

For the researchers, it is crucial that this is an open label but randomised study, in which participants know whether they are receiving the actual drug. This unusual research design would, they argue, tell us more about the real-world effectiveness of PrEP than a blinded study as it would take into account the possible impact of participants taking more sexual risks because they felt that PrEP afforded some protection. (Researchers call this ‘risk compensation’ or ‘behavioural disinhibition’).

Rather than test efficacy in artificial conditions, the study would therefore test effectiveness in more realistic UK conditions.

So far, however, the potential funders of this costly study have not been persuaded by this argument and it is unclear whether the study will be able to go ahead.

What will, however, start recruiting later this year is a pilot version of the same study, aiming to include 500 men who attend one of around twelve sexual health clinics.

As well as allowing the researchers to have a dry run of the main trial and identify teething problems with its strategy, it should also provide valuable information on the number of men who actually follow through on a clinician’s offer of PrEP. Data on the characteristics of men who seek PrEP, drop-out rates and risk compensation will also be collected.

The researchers intend to take some of these data back to the main study’s potential funders, in order to support a revised application.

Acceptability of taking HIV treatment for prevention purposes

As well as asking people hypothetical questions about PrEP, researchers have also been asking people waiting for an HIV test result hypothetical questions about treatment as prevention.

Individuals from high-risk groups attending the Jefferiss Wing at St Mary’s Hospital for HIV testing were given an explanatory paragraph about treatment, infectiousness and safer sex. They were then asked: “If you were diagnosed with HIV would you consider taking treatment to reduce the risk of passing on infection (even if you did not need to take treatment for your own health)?”.

Four out of five respondents said ‘yes’. Encouragingly, gay men who reported unprotected anal intercourse in the past three months were more likely than others to be interested in the idea. Less encouragingly, people who had had a sexually transmitted infection or who had previously taken PEP were slightly less likely to say that they would take treatment for prevention.

The researchers suggested that the latter factor may be associated with PEP users’ experience of side-effects. It contrasts with the findings of the London PrEP attitudes study described above which found people who had previously taken PEP more likely to be interested in PrEP.

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A Tale of Two Trials: How Adherence is Everything in PrEP

Adherence makes all the difference to the efficacy of pre-exposure prophylaxis (PrEP), the 19th Conference on Retroviruses and Opportunistic Infections (CROI) heard on Tuesday.

Further data were presented from two trials of PrEP (giving anti-HIV drugs to HIV-negative people to prevent infection), which announced dramatically different results last year.

In April 2011, the FEM-PrEP study found that giving HIV-negative women tenofovir/FTC (Truvada) pills to prevent their acquiring HIV was totally ineffective: there was no difference in HIV incidence between women taking Truvada and women taking placebo.

In July 2011, however, the Partners PrEP study found that Truvada was 73% effective in preventing HIV transmission between heterosexual partners of different HIV status.

How do we explain why giving HIV-negative women antiretroviral pills made no difference to the HIV infection rate in one trial, but prevented at least two in every three infections in the other? The difference, it appears, is that in the Partners PrEP trial, adherence to the study medication was very high, whereas in FEM-PrEP, despite counselling and support, less than half the women took their PrEP pills regularly.

The Partners PrEP study

The Partners PrEP study enrolled 4758 serodiscordant couples in Kenya and Uganda; the HIV-negative partner was female in 38% of couples. This study had three arms: a daily tenofovir pill, a daily Truvada pill, or placebo.

There were 17 infections in participants on tenofovir, 13 on Truvada and 52 on placebo. Efficacy overall was 75% in those assigned Truvada and 67% in those assigned tenofovir, though confidence intervals (44% to 81% in tenofovir and 55% to 87% for Truvada) overlapped, so the efficacy of the two regimens was the same statistically. The same was true of efficacy observed in women (65%) and men (70.5%).

Adherence according to pill counts of unused medication was 97%. A substudy (Donnell) compared tenofovir levels in the blood of 29 out of the 30 people who became infected in the two PrEP arms with levels in a random selection of 198 people who did not become infected.

Tenofovir was undetectable in the blood of 70% of the people who became infected but only 18% of the people who did not, indicating a ‘true’ adherence level of about 80% – and having a detectable level of tenofovir in the blood was associated with an 86% reduction in HIV risk in those taking tenofovir and a 90% reduction in those on Truvada.

The FEM-PrEP study

In the FEM-PrEP study, 2056 HIV-negative women in South Africa, Kenya and Tanzania were randomised to take a daily Truvada pill or a placebo. The trial was stopped when an interim analysis found near-identical HIV infection rates in both trial arms. There were 33 HIV infections in women taking Truvada and 35 in women taking placebo; this translates into annual incidence rates of 4.7% and 5.0% respectively. This 0.3% difference is no difference at all, statistically speaking (hazard ratio 0.94, 95% confidence interval 0.59 to 1.52, p = 0.81).

Participants in the study said they took their pills 95% of the time and adherence as measured by pill count was 85%. However when drug levels of tenofovir and FTC were measured in the blood of women assigned to Truvada, the investigators found that less than 50% of the women who should have been taking the drug had actually done so in the last 12 days, and less than 40% within the last 48 hours.

In infected participants, 26% had detectable levels of tenofovir in their blood in the last visit before they tested HIV positive, 21% at the visit they tested positive, and 15% at both visits; in non-infected participants whose samples were taken at the same visits they were 35%, 38% and 26% respectively.

Resistance

In FEM-PrEP, there were five cases of drug-resistant virus (all with the single M184V FTC resistance mutation), four in the Truvada arm and one on placebo. Two of the four cases in women assigned Truvada were clearly cases of transmission of virus that was already drug-resistant and not caused by women partially adherent to PrEP becoming infected, while the other two are still under investigation.

There were two cases of drug-resistant virus in Partners PrEP but in both cases these turned out to be people who were enrolled while suffering from acute HIV infection: there were no cases of drug-resistant virus amongst 74 infections post-randomisation.

One observation common to both studies was that the only side-effect that was measurably different between drug and placebo was nausea and vomiting. In Partners PrEP Truvada was associated with a modest increase in gastro-intestinal symptoms in the first month and in FEM-PrEP the rates were also significantly higher. Whether this is enough to deter participants from continuing their pills who are not strongly motivated needs further research.

Why were there differences in adherence?

Jared Baeten and Lut van Damme, principal investigators respectively of Partners PrEP and FEM-PrEP, were asked why they thought adherence was so much lower in FEM-PrEP than in Partners PrEP.

Baeten commented that they were very different populations. The men and women in Partners PrEP had to define themselves as being in a stable relationship – stable enough to last for at least the two-year length of the trial. Partners would have encouraged their spouse to take their pills, and a qualitative study has already confirmed that many participants saw PrEP as an opportunity to preserve their relationship despite the strain imposed by different HIV status.

He was asked why PrEP would be used in a couple where it would be more logical for the HIV-positive partner to be on treatment. He said one use of PrEP within couples might be to bridge the gap in time between the positive partner’s diagnosis and their starting treatment and becoming virally undetectable.

Van Damme said that the women in FEM-PrEP were much younger and had high levels of sexually transmitted infections (STIs). Initial qualitative surveys had shown that many did not believe themselves to be at high risk of HIV, despite high incidence in their community. There was also a high pregnancy rate in the study despite reported high levels of oral contraceptive use, showing that low adherence to medications was not restricted to Truvada. There was no evidence that participants were sharing their pills with others and, contrary to what the data initially suggested, the pregnancy rate was no higher in women taking PrEP, ruling out theories that interactions between the PrEP drugs and the menstrual cycle may have made women more vulnerable to HIV.

“What we have learned from this trial is that risk perception and understanding one’s own risk are important motivators for people to use biomedical prevention methods,” she concluded.

Dr Sharon Hillier of the Microbicides Trial Network, commenting on the PrEP trials at the conference, commented: “PrEP is very, very effective if you use it very, very well.”

References

Baeten J et al. ARV PrEP for HIV-1 prevention among heterosexual men and women. 19th Conference on Retroviruses and Opportunistic Infections, Seattle, abstract 29, 2012. The abstract is available on the official conference website.

Van Damme L et al. The FEM-PrEP Trial of Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) among African Women. 19th Conference on Retroviruses and Opportunistic Infections, Seattle, abstract 32LB, 2012. The abstract is available on the official conference website.

Donnell D et al. Tenofovir disoproxil fumarate drug levels indicate PrEP use is strongly correlated with HIV-1 protective effects: Kenya and Uganda. 19th Conference on Retroviruses and Opportunistic Infections, Seattle, abstract 30, 2012. The abstract is available on the official conference website.

A webcast of the session HIV prevention: PrEP, microbicides and circumcision, is available through the official conference website.

Original Article via NAM

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