NHS England has lost a major judicial review over the power to commission a preventative HIV drug.
The decision, taken at the Royal Courts of Justice, ensures that the healthcare body will be forced to include pre-exposure prophylaxis (PREP) in its “prioritisation process”.
Mr Justice Green asserted that NHS England had “erred in deciding that it has no power or duty to commission” PREP, and in his judgment the organisation has a “broad preventative role”.
In his summing up statements, Green commented that NHS England had “mischaracterised the PREP treatment as preventative when in law it is capable of amounting to a treatment for a person with infection”, and it any event the body had the power to commission preventative treatments because it supported “the discharge of its broader statutory functions”.
The judge said at its core the judicial review was about “the allocation of budgetary responsibility in the health field”, and explained that NHS England had erred in its responsibilities by blacklisting PREP.
“NHS England says it has no power to provide the service and the local authorities say that they have no money. The claimant is caught between the two and the potential victims of this disagreement are those who will contract HIV/AIDS but who would not were the preventative policy to be fully implemented.”
NHS England has indicated that it intends to appeal against the decision, and has also warned that other medicines could be sidelined if the body is forced to fund PREP.
Nine treatments are apparently under threat as a result of the court verdict.
NHS England have indicated previously that it was impossible for the organisation to fund PREP, as the body did not have the legal power to commission the medicine.
The healthcare organisation instead asserted that the responsibility lied with local authorities.
In response to this assertion, the National AIDS Trust launched the judicial review which has ultimately tesulted in the assertions of NHS England being reversed, pending appeal.
However, despite the court verdict, it is not inevitable that NHS England will commission PREP.
NHS England will instead put PREP through its prioritisation process, which it intends to re-run in October.
Deborah Gold, NAT’s chief executive, commented that the judge’s decision was a “vindication for the many people who were let down when NHS England absolved itself of responsibility for PREP”.
Izzi Seccombe, the LGA’s community wellbeing portfolio holder, was also positive about the prospects for HIV sufferers as a result of the verdict.
“By successfully challenging NHS England’s interpretation of the law, we believe this will provide much-needed clarity around the future roles of councils and the NHS on prevention services.”
There was great optimism regarding the future of the treatment of HIV and AIDS when Truvada, an anti-viral drug which helps prevent uninfected, people who are at risk from contracting HIV, passed clinical trials recently.
But it now seems that a financial squabble could put a spanner in the works, with the UK health service and local councils currently in a disagreement over who should ultimately pay for the treatment.
It previously appeared after a lengthy spell of negotiation that NHS England would ultimately foot the bill for the drug being introduced across England.
However, on 21st March NHS England announced it would mount a two-year, £2 million pilot study of 500 men at high risk of infection to assess the efficacy and cost of the drug.
And NHS England has since backed away from funding the drug, indicating that the bill should instead be met by local authorities, which provide other HIV services.
Sarah Radcliffe at the National AIDS Trust charity has been extremely critical of this decision, pointing to the laborious 18-month process that led to the approval of Truvada in the first place.
Radcliffe believes that there is extremely decisive evidence which indicates that the drug is defective, and will in fact ultimately reduce healthcare cost in the NHS.
Teresa O’Neill of London Councils points out that it costs £380,000 to treat an HIV-positive person for life, versus £4,700 to supply Truvada for a year, so a patient would need to consume the drug for 80 years before it became more expensive.
This is particularly disappointing considering the effectiveness of the drug in treating HIV.
While it is known that no treatment can be completely perfect in preventing the killer illness, the record of Truvada is clearly outstanding.
Since 2012, Truvada has been prescribed to HIV-negative individuals in high-risk populations in the United States who wish to prevent infection.
Just last September, an analysis by researchers at Kaiser San Francisco found no new HIV infections in over a two-and-a-half-year period among patients who took the drug.
There has recently been an example of a 43 year-old male who has apparently contracted HIV while taking Truvada, but the overall record of the medicine in clinical conditions is clearly outstanding.
Seminal AIDS researcher Dr. Paul Volberding is extremely enthusiastic about Truvada’s effectiveness in preventing HIV transmission, describing its efficacy as “the kind of effect we might expect from a very good vaccine.”
However, it seems that patients in the UK will not be able to benefit from this drug and medicine in the foreseeable future, at least until the financial quarrel is settled.
The HIV-preventing drug PrEP could soon be available on the NHS, under the trade name of Truvada.
PrEP can significantly reduces the chances of people being infected with the deadly HIV virus when taken on a daily basis.
In an attempt to address the spread of AIDS in the United Kingdom, a £50 million scheme will see the new PrEP drug available to men via the NHS.
The initiative comes in the context of new research which indicates that consuming the drug could reduce the chance of new HIV infections by as much as 50 per cent.
Already the scheme has been praised by proponents of the PrEP drug, who suggest that it will be a game changer for the treatment of HIV.
New research indicates that PrEP will prevent thousands of men from contracting HIV over the next few years.
Initially, PrEP was considered somewhat controversial, but has recently become more widely accepted, and is now available in numerous jurisdictions overseas.
Although there were initial fears that PrEP could lead to homosexuals in particular taking more sexual risks, trials have indicated a superb success rate for the new medicine.
It has been demonstrated that PrEP can cut the risk of contracting HIV by around 90 per cent.
Research outlining a model of the usage of the drug has already been published in the Lancet.
And it has been calculated by the authoritative journal that infection rates of HIV could plummet by as much as 59 per cent in gay and bisexual men as a result of the PrEP NHS availability.
This was based on a projection of all gay men in the UK being offered the drug. In theory, this could lead to preventing 10,000 new diagnoses by 2020.
Narat Punyacharoensin, of the London School of Hygiene & Tropical Medicine, and the lead author of the study, commented on the issue.
“Current prevention efforts in the UK that focus on correct and consistent condom use and regular HIV testing have been falling short. Our results show that pre-exposure prophylaxis offers a major opportunity to curb new infections and could help reverse the HIV epidemic among men who have sex with men in the UK.”
The health authorities have been similarly positive about the potential of this new treatment.
A spokesman for NHS England commented: “NHS England is working with local authorities and others across the NHS to consider the clinical and cost effectiveness of providing pre-exposure prophylaxis to at-risk groups.”
A new study attempts to address concerns about the side-effects of HIV-preventing PrEP drugs – finding the drugs are as safe as Aspirin.
More people than ever are living with HIV in the UK and each year new infections occur.
Over 103,000 people are living with HIV in the UK, with 17 per cent of sufferers currently undiagnosed.
Alarming figures from UNICEF indicate that the number of children and teenagers who died from AIDS increased by more than 300 per cent in little over a decade.
According to the charity, the majority of adolescents who required the immune system condition contracted it when they were infants.
Although breakthroughs have been made in treating AIDS in poorer areas of the planet, the virus remains of of the biggest killer of people aged between 10 and 19 in Africa.
And it also remains the second largest killer of adolescents globally.
UNICEF is the children’s agency of the United Nations, and its latest report indicates that the number of adolescents dying from AIDS worldwide has more than tripled in the last 15 years.
Among other critical information, the latest statistical report from UNICEF indicates that “among HIV-affected populations, adolescents are the only group for which the mortality figures are not decreasing. Most adolescents who die of AIDS-related illnesses acquired HIV when they were infants, 10 to 15 years ago, when fewer pregnant women and mothers living with HIV received antiretroviral medicines to prevent HIV transmission from mother to child.”
According to the charity, many young people who ultimately lose their lives to AIDS survive throughout their teenage years without ever gaining the knowledge that they have contracted the HIV virus.
And about half of the two million people living with HIV in this group live in just six countries: South Africa, Nigeria, Kenya, India, Mozambique and Tanzania.
UNICEF notes that sub-Saharan Africa remains a hotbed for the virus, and that the African continent faces massive challenges with regard to dealing with the condition.
“In sub-Saharan Africa, the region with the highest prevalence, girls are vastly more affected, accounting for seven in 10 new infections among 15 to 19 year olds. But for the sake of the children and adolescents still affected, and for all future generations, we cannot mistake advancement for attainment,” UNICEF observes.
Commenting on at the data, Craig McClure, head of UNICEF’s global HIV / AIDS programmes, outlined the critical nature of this issue.
“It is critical that young people who are HIV-positive have access to treatment, care and support. Only one in three of the 2.6 million children under the age of 15 living with HIV are on treatment. Since 2000, nearly 1.3 million new infections among children have been averted, largely due to advances in the prevention of mother-to-child transmission of HIV By 2014, three in five pregnant women living with HIV received antiretroviral treatment to prevent transmission of the virus to their babies. This has translated into a 60 per cent reduction in AIDS-related deaths among children under four years of age since 2000,” the McClure stated.
Since 2000, 38.1 million people have become infected with HIV and 25.3 million people have died of AIDS-related illnesses.
In 2014, an estimated 36.9 million people were living with HIV (including 2.6 million children) – a global HIV prevalence of 0.8 per cent.
A new tablet intended to prevent HIV infections in individuals at particularly high risk appears to provide a large success rate.
Two new studies that assess the efficacy of Truvada, manufactured by Gilead, conclude that the medicine is positively impacting on the development of HIV.
The first of the two studies was conducted in the San Francisco area, and researchers found that 657 people who consumed Truvada on a daily basis did not contract HIV.
Truvada’s efficacy was also tested in another study in the UK, in which it was found that people taking the drug had a significantly lower risk of HIV diagnosis.
The pill in question has already been approved in the U.S. for “pre-exposure prophylaxis” (PrEP) of HIV.
And the U.S. Centers for Disease Control and Prevention has suggested that Truvada can reduce the risk of HIV infection by up to 92%.
It is notable, though, that the drug provides no protection against other forms of sexually transmitted diseases.
Truvada has typically worked extremely well in laboratory conditions compared to a placebo, but prior to real-world surveys, there were concerns about the ability of the drug to operate outside of clinical trials.
However, the San Francisco study, which was published in Clinical Infectious Diseases, seems to provide the strongest evidence yet that Truvada is indeed effective in overcoming HIV.
In mitigation, it should be noted that the relatively small incidence of HIV cannot be entirely confidently attributed to the usage of Truvada.
Other factors such as regular GP visits, enabling more opportunities for doctors to locate infections, could also have played a significant part in the results.
The UK study of Truvada was published in the renowned Lancet, and found that gay men who consumed the drug experienced significantly fewer new HIV infections than those who went without.
There was quite a significant gulf between the two control groups as well, with those not taking the drug apparently nine times more likely to contract the deadly HIV virus.
Founder and co-chair and medical research director of the Fenway Institute, Dr. Kenneth Mayer, commented on the findings, suggesting that the research represented serious vindication for the effectiveness of the drug.
“I don’t think PrEP is the magic bullet, but we know that it does work really well,” Mayer said. “It’s great to know we have options.”
Based on estimates from clinical trial data, as many as 35 new HIV infections may have been prevented among the PrEP users.
The number of people living with HIV in the UK has doubled in the last 10 years, with around 100,000 people currently thought to be living with the illness.
A new drug that has a significant influence on the likelihood of being infected with HIV is being strongly promoted by experts.
Pre-exposure prophylaxis (PrEP) is being heralded as a massive breakthrough in treating HIV and AIDS, after researchers in a UK-based study found that it decreased infections by 86 per cent among gay men at high risk.
Scientists involved in the study opined that the NHS simply “cannot afford to ignore” this HIV treatment.
Having carried out a trial at 13 sexual health clinics last year, researchers involved in the test have now published results in The Lancet.
The initial tests were accelerated as it became clear that the drug was extremely effective.
Results indicate that one case of HIV could be prevented for every 13 men taking PrEP, which is considered to be an outstanding result.
The pill in question is referred to as Truvada, and it is already widely available in the United States. The NHS is now examining whether offering this drug free to high risk groups is feasible.
Although the early results regarding this pill are extremely positive, that decision on its availability is not expected until early in 2016.
However, it seems that prescriptions of PrEP may offer not only medical benefits but financial savings to the NHS as well.
The potential decline in HIV infections caused by the drug suggest that PrEP could save the NHS a considerable amount of money in the medium to long-term.
Researchers for the Lancet-published review were led by Professor Sheena McCormack of the Medical Research Council clinical trials unit at University College London (UCL).
The group concluded that “National health services are under financial constraints, but they cannot afford to ignore the results of PROUD and [separate PrEP trial] IPERGAY, which strongly support the addition of PrEP to the current standard of prevention for men who have sex with men at risk of HIV infection.”
This latest pill arrives in the context of the battle against HIV having read something of a logjam.
The number of new HIV infections in UK has remained static for 10 years, with around 3,250 new cases in 2013.
However, despite the current efficacy of this treatment, decisions about cost-effectiveness will have to encompass the significant cost of treating HIV infections.
This figure can rise as high as £11,000 per year, while clarification on the criteria for qualifying for a free PrEP prescription also needs to be agreed.
Dr Ian Williams, Chair of the HIV clinical reference group for NHS England, commented positively on the Lancet study “We want to see reductions in new transmissions of HIV infection and are already investing in programmes to achieve this. These findings add to existing international evidence on preventing infection, and consideration is already being given to how best to make further progress.”
As PrEP is a specialist HIV drug, a final decision on the pill will be made by NHS England, as opposed to the National Institute of Health and Care Excellence.