People with HIV infection that is well controlled through combination drug therapy face the same risk of premature death as people without HIV.

A new UK study has shown that antiretroviral therapy (ART) can maintain undetectable viral loads and near-normal levels of immune cells.

Short of a fully effective vaccine against HIV infection, these patient outcomes represent the greatest possible success in treatment of the virus.

The study, published in the journal AIDS, was conducted by Dr Alison Rodger and other research scientists at University College London.

It covered 3,300 patients drawn from two major clinical trials of HIV drugs: the ESPRIT and SMART trials. All of these patients received continuous ART, 80% were male, and their average age was 43 years.

At time of trial, all of the patients had undetectable HIV levels and normal or near normal levels of CD4+ immune cells (at least 350 cells/mm³ where 500–1,000 is normal).

During a three-year follow-up period, 62 patients died – and only two of these deaths were considered AIDS-related.

Those patients whose CD4+ cell counts were between 350 and 499 cells/mm³ had a 77% higher risk of premature death than the general population.

However, those patients with a CD4+ cell count of 500 cells/mm³ or higher had the same mortality rate as the general population.

The researchers concluded: “Our data support the importance of early diagnosis and treatment to improve clinical outcomes, and it is likely that much of the excess mortality associated with HIV would be preventable with timely diagnosis of HIV and initiation of ART.”

Further studies will aim to determine the optimum time to start ART based on the patient’s CD4+ cell count.

An experimental cancer drug can act as a ‘searchlight’ for HIV that is latent in the body, exposing it to antiretroviral therapy.

The experimental drug JQ1 was developed at Harvard Medical School as a treatment for cancer, but may have further applications.

JQ1 may be able to reactivate latent HIV, which is otherwise highly resistant to drug therapy.

While antiretrovirals have succeeded in prolonging the lives of many people infected with HIV by reducing their bloodstream ‘viral load’, eradicating the virus is rarely possible.

Researchers at Boston University added JQ1 to latently HIV-infected cells and observed strong reactivation of the virus.

“This drug may be useful as adjunctive therapy in efforts to purge latent HIV reservoirs to eradicate infection,” said Monty A. Montano, principal investigator at the Section of Infectious Diseases, Boston University Medical Campus.

John Wherry, Deputy Editor of the Journal of Leukocyte Biology, noted that HIV drug research has been “a series of incremental steps” with drugs developed separately working in combination.

“The hope is that the ability of JQ1 to make latent HIV ‘visible’ to other HIV drugs will be another cog in the gearwheel of an HIV cure,” he concluded.

Johnson & Johnson has said it will not enforce patents on its HIV drug Prezista (darunavir) in Africa and other poor regions of the world.

The decision will ensure that many patients have access to cheaper generic versions of the drug.

However, J&J insists that generic darunavir must be of high quality, and reserves the right to enforce its patents if this is not the case.

The company has declined to join the new Medicines Patent Pool, which aims to accelerate generic drug production.

J&J came second in the Access to Medicine Index 2012, which scores major pharmaceutical companies on the access to their drugs in poorer countries – seven places higher than its 2010 placing.

Multiple generic manufacturers will now be able to produce generic darunavir for sale in sub-Saharan Africa and other ‘least developed countries’.

The drug is a second-line therapy for patients who have developed resistance to the standard antiretroviral drugs. Demand for it in Africa is increasing rapidly.

Paul Stoffels, J&J’s Head of Pharmaceuticals, said that competition between generic manufacturers would drive down the price of darunavir.

Indian pharmaceutical companies would be particularly quick to bring out generic versions of the drug, he predicted.

Stoffels defended the decision to stay out of the Medicines Patent Pool: “We want to reserve the right to reinforce patents if people are not providing the right quality of product, for example by bringing products to market that under-dose.”

Most of the leading pharmaceutical companies are improving access to their medicines in the developing world, a new report shows.

The Access to Medicine Index identifies GSK, J&J and Sanofi as the companies doing most to make their drugs available and affordable in poorer countries.

Better pricing deals and development of drugs for neglected diseases are among the areas of company activity praised by the report, but the management of drug trials in developing companies is criticised.

GSK, which topped the Index in 2010, remains in front though its overall rating is only slightly higher. J&J and Sanofi have significantly improved their ratings.

The major Japanese firms are bottom of the league, as well as being absent from such initiatives as the WHO campaign to fight neglected tropical diseases.

In its third year, the Netherlands-based Index notes that companies are showing better internal organisation in relation to drug access issues.

Of the 20 largest pharma companies, 17 have improved access to their drugs in the developing world since 2010: they are developing more relevant drugs and doing more to facilitate patient access to them.

In particular, more companies are using tiered pricing schemes to make products more affordable for certain countries or population groups – most notably Gilead, whose HIV drugs are used worldwide.

However, the Index states that companies could do more to support generic versions of their drugs and adapt drug packaging to local needs.

It also notes that the outsourcing of clinical trials to Contract Research Organisations lacks transparency and control, with only four companies (GSK, Sanofi, Eisai and Merck & Co.) saying they enforce ethical codes.

Wim Leereveld, CEO of the Index, said: “Access to medicine is a multi-faceted challenge and the pharmaceutical industry has a critical role. While it has made strides in many areas, companies that have sector-leading practices also show us there is more the industry can contribute.”

In the first of a new series Pf editor John Pinching prescribes a double dose of feature films in which pharmaceuticals have made memorable cameos. This month the line up includes a daft hospital caper and everyone’s favourite heroin addiction yarn.

Trainspotting (1996)

The goodwill, joy and relentless optimism of Danny Boyle’s momentous Olympic opening ceremony made Trainspotting seem like a distant memory – a brilliant germ festering in the darker echelons of the director’s CV. This heroin laced, quintessentially Scottish gem from the mid-nighties remains Boyle’s masterpiece. It managed brilliantly to combine bold cinematic shots, with the raw intensity of independent films, while juxtaposing pure fantasy with sobering realism. The film’s primary focus is a group of heroin addicts, imprisoned by their all-encompassing addiction.

Its central protagonist, Renton, and his hopeless companions, ‘Sick Boy’ and ‘Spud’, will do anything to get a fix. If this means striking a deal with AIDS and cancer patients for their pharmaceutical drugs, then so be it. This insatiable appetite for weird drug cocktails prompted the following memorable piece of narration, “We took morphine, diamorphine, cyclozine, codeine, temazepam, nitrezepam, phenobarbitone, sodium amytal dextropropoxyphene, methadone, nalbuphine, pethidine, pentazocine, buprenorphine, dextromoramide chlormethiazole. The streets are awash with drugs that you can have for unhappiness and pain, and we took them all. Fuck it, we would have injected Vitamin C if only they’d made it illegal.”

Renton then insists that middle class consumers of pharmaceutical drugs, like his mother are, in their own “socially acceptable way, also drug addicts.”

As his habit reaches a nadir, Renton takes a massive overdose and ends up being revived in a destitute hospital corridor by exasperated and world-weary staff – a far cry from Boyle’s somewhat misty eyed NHS view this summer.

Carry on Matron (1972)

Granted, there haven’t been many hilarious comedies about the contraceptive pill, but this, is a notable exception. The ‘Carry On’ team’s usual highly sophisticated tapestry of innuendo, surfaces in the familiar surroundings of an NHS hospital and, naturally enough, medicinal madness ensues.

The man with ‘a face like an unmade bed’, Sid James, plays the ringleader of a hapless gang, intent on stealing medication and selling it on the black market (like the pre-internet equivalent of those nuisance ‘Viagra’ emails).

In order to infiltrate the hospital, and find out where supplies of ‘the pill’ are kept, Sid convinces his son, Cyril (Kenneth Cope) to masquerade as a female nurse. There are awkward consequences, such as being repeatedly molested by Terry Scott (Dr Prodd) and having to get changed in front of another woman. Eventually the scam is exposed by alert patients in the maternity ward. When threats are made to call the police, however, the gang finally reveal that Cyril is a man, and the feuding sides reach an agreement to keep their dirty secrets!

The film’s other notable performances come from Kenneth Williams – whose pomposity is matched only by the weirdness of Charles Hawtrey – and Hattie Jacques, who never tires of her role as ‘matron’. Meanwhile, Barbara Windsor, Jackie Piper and Valerie Leon provide the ‘skirt’.

Global HIV company ViiV Healthcare has committed £4m to support community projects aimed at reducing the impact of HIV on mothers and children.

The company, an alliance started by GSK and Pfizer, is using its Positive Action for Children Fund (PACF) to support grassroots projects in 26 countries.

The projects emphasise education, prevention and community engagement, and focus in particular on the prevention of mother to child HIV transmission.

An example is the Happy Children initiative in Zambia, which ensures that children born to mothers with HIV receive antiretroviral prophylactic therapy within 72 hours of birth.

The number of children aged below 15 who are living with HIV has reached 3.4 million worldwide.

“Part of ViiV Healthcare’s unique approach is providing valuable support to local community organisations that are making a difference on the ground for the communities in which they live,” said Dr Dominique Limet, CEO of ViiV Healthcare.

Professor Catherine Peckham, Chair of the PACF Board, noted: “PACF recognises a uniquely broad mix of organisations committed to improving the standard of access to care for key populations.”

ViiV Healthcare aims to commit close to £30m by 2015 in community-based programmes to protect mothers and children from HIV and AIDS.

The company, which has support from Shionogi as well as Pfizer and GSK, aims to deliver new anti-HIV medicines and support communities affected by the virus.

A new intravaginal ring for delivery of tenofovir (TFV) could offer a breakthrough in drug-based prevention of HIV infection in women.

The new reservoir device enables 90-day delivery of the only topical microbicide drug known to be effective in protection against HIV.

Researchers describe the ring as adaptable to almost any drug, providing consistent drug delivery at an adaptable rate.

The use of the ring for long-term delivery of TFV has been shown to be clinically as effective as repeated short-term application of TFV gel.

The research, presented to the American Association of Pharmaceutical Scientists (AAPS), could have wide-ranging implications in sexual health.

A version of the ring that delivers TFV and the hormonal contraceptive levonorgestrel at the same time has also been developed.

Lead researcher Patrick Kiser said: “We anticipate that this next-generation ring will be able to release a spectrum of drugs that currently cannot be delivered due to limitations of standard technology.

“This ring is a breakthrough design because it is highly adaptable to almost any drug; the amount of drug delivered each day is the same and the release rate can be modified easily if needed.”

The risk of HIV infection is growing in the UK due to lack of awareness among young adults, experts have said.

The issue presents a challenge for the new public health strategy, in which local authorities will have responsibility for sexual health.

The Department of Health has allocated £8m to the voluntary sector to raise awareness of HIV in England.

According to the Health Protection Agency, nearly 3,500 young adults (aged 16 to 24) have been diagnosed with HIV in the last five years.

London-based sexual health expert Paul Steinberg commented that younger people were not exposed to past HIV awareness campaigns and took for granted its treatability through combination therapy.

The disease has “dropped off the radar” for many people, he said, but it remains incurable and life-limiting.

After April 2013, responsibility for sexual health will shift from NHS to local authority control. However, HIV treatment will be handled by the NHS Commissioning Board.

The Department of Health recently allocated £8m to the Terrence Higgins Trust, the leading AIDS charity, to raise awareness of HIV over the next three years.

The charity has been asked to target those groups most at risk of HIV infection through sexual activity: gay men and black and African people.

The issue reflects the global nature of public health issues relating to infectious diseases, as well as the complexity of the new public health system in England.

A new HIV drug from GlaxoSmithKline and Shionogi has been shown in a phase III trial to be as effective as Merck’s Isentress.

Dolutegravir is potentially a challenge to Isentress (raltegravir) in the aromatase inhibitor class of drugs, which block the HIV virus from entering cells.

Isentress, which brought in $1.4bn for Merck last year, is currently the only aromatase inhibitor to gain regulatory approval.

A new phase III clinical trial showed that dolutegravir was non-inferior to Isentress when given for 48 weeks alongside two older HIV drugs – and its once-daily dosage regime gave it the edge over its twice-daily rival.

Dolutegravir suppressed the HIV virus in 88% of patients, while Isentress did so in 85% of patients. Both drugs showed similar tolerability.

The new drug belongs to ViiV Healthcare, a joint venture of GSK and Pfizer, but was co-developed by ViiV and Shionogi.

As a result, GSK (which has an 85% stake in ViiV) will have to share some of the revenue from dolutegravir with Pfizer and Shionogi.

However, the new drug – predicted by analysts to bring in as much as $1bn per year – will certainly strengthen GSK’s portfolio for HIV treatment.

Pending the results of further phase III trials, dolutegravir could be filed for regulatory approval before the end of this year.

The effect of antiretroviral drugs in reducing the spread of HIV infection has been confirmed in a community setting.

A study from rural South Africa has shown that people living in areas where more than 30% of people with HIV are taking antiretrovirals have a 34% lower risk of acquiring the virus than those living in areas of less than 10% uptake.

The study reinforces recent clinical findings that found antiretroviral drugs reduced the risk of HIV transmission to an uninfected partner by 96%.

Carried out by the Africa Centre for Health and Population Studies, the study used HIV surveillance data collected since 2003 in KwaZulu-Natal.

In a region where 20,000 people with HIV have accessed antiretroviral treatment since 2004, the study followed 16,500 people from 2004 to 2011.

The researchers found that every percentage point increase in antiretroviral coverage was associated with a 1.7% fall in the risk of HIV infection.

South Africa has recently expanded the eligibility criteria for treatment with antiretrovirals, giving people with HIV access to the drugs if their CD4 cell count is below 350.

Paul De Lay, Deputy Executive Director of the UN programme UNAIDS, said: “These findings are extremely important. UNAIDS encourages all countries and communities to achieve high coverage of antiretroviral therapy, both for the benefit of people living with HIV and for the communities in which they live.”