News (Updated May 3, 2010)

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Model gives insight into HIV vaccines

Apr 30, 2010

HIV-1 budding from a 
lymphocyte

Researchers in China have created what they claim is the most "detailed and realistic" model of HIV to date, and say that it could help in the creation of a vaccine for the deadly virus. However, immunologists warn that the model is yet to catch up with modern clinical trials.

According to the World Health Organization, HIV is one of the world's biggest health challenges, infecting almost three million people and killing some two million people every year. When a person is infected, HIV enters into the immune system's crucial T lymphocytes – or T cells – and replicates itself by integrating with the DNA. As a result the cells die and the immune system slowly weakens until it can no longer fight off opportunistic infections, a status classified as AIDS.

The scale of the AIDS epidemic has prompted many scientists to search for an HIV vaccine, but this has proved difficult. HIV is different from other viruses in that it can mutate very quickly, thereby evading the normal immune-system defences. Some scientists think that a vaccine will only become available once there is a leap in the theoretical understanding of the virus.

'Detailed and realistic'

Physicist Jianwei Shuai and chemical biologist Hai Lin of Xiamen University now think they have a model that will help with that understanding. "We propose a more detailed and realistic HIV model than previous models, by incorporating many important features of HIV dynamics," says Shuai.

In the model, single HIV particles, known as virions, sit on lattice sites alongside two types of T cell: CD4+ T cells, which direct other immune-system cells, and CD8+ T cells, which kill infected cells. The virions and cells take a "random walk" around the lattice sites until two meet each other, at which point they interact in one of several ways. At the same time, the model takes into account the virions' mutations and the responses of the T cells.

One of the results of the researchers' model concerns the so-called asymptomatic phase in HIV-positive patients – the period from which they are infected with HIV to when they begin to develop AIDS. Although for the majority of people this phase is 5–10 years, it can be 15 years or longer. Physicians had thought the discrepancy was due to the abilities of different patients' immune systems, but Shuai and Lin think the reason could simply be a product of the immune system's random response.

Decisive role

A potentially more important result, however, comes in the way that the two types of T cell react to HIV. In their model, Shuai and Lin found that it is the CD8+ T cells that play a decisive role in suppressing the virus. "This observation implies that CD8+ T-cell response might be an important goal in the development of an effective vaccine against AIDS," explains Shuai.

Yet some researchers claim that this result is nothing new. "The model makes a large number of assumptions, none of which are examined by comparison to [clinical] data," says Alan Perelson, a theoretical immunologist at Los Alamos National Laboratory , US . "That CD8+ T cells might be important in suppressing viral load is not novel, and in fact was the basis of the large trial that failed to provide protection."

Mathematical exercise?

David Ho, an AIDS scientist at the Aaron Diamond Research Center in New York , is also critical of the results. "Playing with math to fit clinical data is just an exercise," he says.

Still, Shuai and Lin are planning to take their model further. By modelling the effects of different drugs, they hope to find an optimal therapy to fight HIV.

The research is available to read free in the New Journal of Physics.

About the author

Jon Cartwright is a freelance journalist based in Bristol , UK

 

FDA probes risks of HIV, prostate, other drugs

WASHINGTON

May 3, 2010

WASHINGTON (Reuters) - Regulators are investigating potential risks from Abbott Laboratories Inc's HIV drug Kaletra, GlaxoSmithKline Plc's prostate drug Avodart and other medicines.

The Food and Drug Administration said on Monday it was probing reports of liver toxicity with patients who used Kaletra to prevent HIV infection after exposure to the AIDS virus.

The agency also said it was investigating cases of male breast cancer in patients treated with Avodart as well as Merck & Co's prostate drug Proscar and baldness treatment Propecia.

The FDA releases a quarterly list of safety probes to inform the public about early investigations of potential side effects that have been reported. The list released on Monday covered issues identified between October and December 2009.

Being on the list does not mean the FDA has concluded the drug causes the specific risk, the agency said.

 

AIDS-related deaths continue to fall, diseases of ageing and lifestyle on the rise in people with HIV

Michael Carter, Wednesday, April 28, 2010

Lifestyle and social factors need to be addressed if the full potential of HIV treatment to lower mortality is to be realised, according to results from a large cohort study published in the May 15th edition of Clinical Infectious Diseases.

Diseases associated with ageing but nevertheless influenced by HIV infection, and risk behaviours associated with HIV infection, such as cardiovascular disease, non-AIDS-defining cancers, kidney disease and liver disease, are the causes of death in a growing proportion of people with HIV, while deaths from AIDS-defining causes such as opportunistic infections and AIDS-defining cancers have fallen over the past ten years.

Investigators from the international Antiretroviral Therapy Cohort Collaboration examined recorded causes of death amongst patients taking HIV treatment in Europe and North America between 1996 and 2006. Mortality due to AIDS fell, but mortality due to non-AIDS-related diseases, such as lung cancer, increased.

Their retrospective analysis included 13 studies, which included a total of 39,272 patients.

These individuals contributed a total of 154,667 person-years of follow-up, the median duration of follow-up for each patients being a little under four years.

At the time HIV treatment was started, the patients had a median age of 37 years. The median calendar month when antiretroviral therapy was initiated was December 2000. The majority of patients (62%) took a combination that included a protease inhibitor.

There were a total of 1876 deaths (5%). The overall mortality rate was 12 deaths per 1000 person-years. Those who died had a lower median CD4 cell count at baseline (110 cells/mm3) than those who survived (217 cells/mm3).

A cause of death was recorded for 1597 patients. Almost half (49.6%) were due to AIDS. When the investigators looked at the AIDS-related mortality in further detail, they noted that 23% of all deaths were due to AIDS-defining infections and 15% to AIDS-defining cancers.

Non-AIDS-defining cancers were the next most common cause of death (12%). Over a third (37%) of non-AIDS-defining cancer deaths were caused by lung cancer.

Infections not considered AIDS-defining caused 8% of all deaths, and 8% of deaths were also attributed to cardiovascular death. Violence accounted for 8% of deaths, liver disease for 7%, respiratory diseases for 2% and renal failure for 2% of mortality.

The cause of death changed over time. The proportion of AIDS-related deaths fell from 58% in 1996-99 to 44% in the period 2003 to 2006. The percentage of deaths due to AIDS-defining cancers fell from 21% in the earlier period to 13% after 2003.

However, at the same time non-AIDS-defining cancers became an increasingly important cause of death. The proportion of deaths attributed to such malignancies more than doubled from 7% before 1999 to 15% in the period between 2003 and 2006.

A low CD4 cell count was associated with an increased risk of death from non-AIDS-related cancers (HR per 100 cell/mm3 fall = 1.43; 95% CI, 1.34 to 1.53)and renal cancers (HR per 100 cell/mm3 fall = 1.73; 95% CI, 1.18 to 2.55).

“The strong inverse association of rates of death due to AIDS with CD4 cell counts at the time of starting antiretroviral therapy supports arguments for earlier initiation of antiretroviral therapy,” comment the investigators.

A baseline viral load above 5 log10/copies/ml was significantly associated with an increased risk of death due to AIDS (HR = 1.31; 95% CI, 1.12 to 1.53), infections (HR = 1.85; 95% CI, 1.25 to 2.73), cardiovascular disease (HR = 1.54; 95% CI, 1.05 to 2.27), and respiratory disorders (HR = 3.63; 95% CI, 1.30 to 10.09).

“Systematic immune activation secondary to high viral replication, rather than additional or additional to immunodeficiency, may promote death from infections and cardiovascular disease,” write the study’s authors.

Mortality rates for all causes with the exception of renal disease were higher for injecting drug users than other risk groups. Especially strong associations between injecting drug use and death due to liver disease, respiratory illnesses, violence and infections were observed.

Older age was strongly associated with an increased risk of death from non-AIDS-related cancers (HR per 10 years = 2.32; 95% CI, 2.04 to 2.63), and cardiovascular disease (HR per 10 years = 2.05; 95% CI, 1.76 to 2.39). The rate of kidney-related death was especially high amongst patients aged over 60.

The investigators believe that these results “imply that the process of aging will become a dominant factor in HIV mortality in the next decade.”

Overall, mortality rates were 16% were lower in women in men. In addition, women were 50% less likely than men to die of non-AIDS-related cancers.

As the duration of antiretroviral therapy increased, the risk of death from AIDS, non-AIDS-related infections, and kidney disease decreased (p < 0.001).

Starting HIV therapy after 2000 was associated with a significant reduction in the risk of death due to AIDS (p < 0.001).

“Antiretroviral therapy continues to dramatically reduce rates of mortality attributable to HIV infection in high-income countries,” conclude the investigators.

However, they express concern about the high mortality rates due to conditions “associated with social and lifestyle factors…the importance of lifestyle is reinforced by the observation that the most common non-AIDS malignancy was lung cancer, likely caused by smoking.”

The investigators believe that these findings have implications for the care of patients with HIV. They suggest: “interventions to address risk factors for lifestyle-related causes of death, as well as monitoring for and care of diseases associated with old age, will be necessary if the full benefit of antiretroviral therapy in decreasing mortality is to continue n the second decade of antiretroviral treatment.”

Reference
The Antiretroviral Therapy Cohort Collaboration. Causes of death in HIV-1-infected patients treated with antiretroviral therapy, 1996-2006: collaborative analysis of 13 HIV cohort studies. Clin Infect Dis 50: 1387-96, 2010.

 

Many new HIV diagnoses in people aged over 50, including recent infections

Roger Pebody, Friday, April 30, 2010

In the United Kingdom , one in twelve HIV diagnoses are of a person over the age of 50. Whilst rates of late diagnosis are high in older adults, just under half of these diagnoses are thought to be of an infection that was acquired when the person was over the age of 50.

Ruth Smith of the Health Protection Agency announced these findings at the joint conference of the British HIV Association (BHIVA) and the British Association for Sexual Health and HIV (BASHH) last week. Also at the conference, other studies highlighted issues involved in the treatment and care of older people with HIV.

During the period 2000 to 2008, one in twelve (8.5%) new adult HIV diagnoses were in a person over the age of 50. The numbers increased year on year, from 304 in 2000 to 787 in 2008.

The profile of people diagnosed over 50 is somewhat different to those diagnosed at a younger age. They are more likely to be male, homosexual and white than other groups. The HPA have noted a number of diagnoses in older heterosexual men who acquired their infection in southeast Asia.

By looking at the CD4 count at the time of diagnosis, the researchers were able to estimate how long each person had had HIV when diagnosed. Just under half (48%) of infections were thought to have been acquired when the person was over 50, suggesting that prevention work cannot ignore older adults.

Nonetheless, late diagnosis is more of a problem in older adults than in younger groups. A total of 48% are diagnosed with a CD4 count below 200 cells/mm3, compared to 33% of people under 50. In gay and bisexual men, double the number of over-50s are diagnosed late compared to younger men (40% and 21% respectively).

Moreover, these late diagnoses make a substantial contribution to short-term mortality. Amongst people diagnosed over the age of 50, 14% of those diagnosed late died within a year, compared to 1% of people not diagnosed late.

Whereas people over the age of 50 represented 11% of the individuals accessing HIV care in 2000, they now make up 17% of those doing so.

Other studies at the conference looked at the treatment and care needs of these older adults. A poster profiled 257 patients aged 50 or over attending HIV services in Brighton . The vast majority were white gay men, their mean age was 58 and they had lived with HIV for an average of 12 years.

85% of patients had at least one co-morbidity, with 43% having three or more. As a result, in addition to anti-HIV drugs, two-thirds of patients were taking medication for other conditions (12% reported five or more other drugs) and 79% of patients were under the care of other medical specialists (dermatology, ENT, cardiology, gastroenterology, etc,). The authors recommended that HIV clinicians should work in close co-operation with these other specialists.

Another poster highlighted the importance of carrying out additional tests and assessments, for example for prostate cancer and other malignancies. Moreover regular review of all medication is required to monitor possible drug-drug interactions.

Finally, the Brighton researchers also presented findings from 20 in-depth qualitative interviews with people with HIV aged between 52 and 78 (mean age 64). Almost all were white gay men.

Some of the key themes were:

Health: concerns about the unknown effects of HIV and antiretroviral treatment over time; the number of co-morbidities; a desire to have continuity of medical care and more psychosocial support. “Obviously the antiretrovirals are keeping me alive but there must be some long-term damage,” said one interviewee.

 

Survival: stories of outliving peers and of not having prepared for the future because none was expected. “They’re all dead and I’m the only one left alive and I’ve got no pension.”

 

Self-esteem and rejection, linked to a youth-orientated gay scene, changes in physical appearance and sexual dysfunction. “Who wants an old faggot like me?” was one comment from the interviews.



References

Smith R et al. Refocusing our efforts – transmission and late diagnosis of HIV among adults aged 50 and over. HIV Medicine 11 (supplement 1), O3, 2010.

Patel R et al. Greying with HIV: an observational study of healthcare needs of HIV-infected patients aged 50 years or over. HIV Medicine 11 (supplement 1), P68, 2010.

Ward B et al. Ageing and HIV/AIDS: evaluation of a dedicated clinical service for HIV-infected individuals over 50 years of age. HIV Medicine 11 (supplement 1), P66, 2010.

Perry N et al. i>Growing older and living longer with HIV-1 – a qualitative study. HIV Medicine 11 (supplement 1), P79, 2010.

 

GSK relies more on emerging markets

By Andrew Jack

Published: April 29 2010 03:00 |

Strong sales in emerging markets and from pandemic flu vaccines helped GlaxoSmithKline cut its traditional reliance on pills sold in western markets to a quarter of turnover, as it reported results for the first three months of 2010.

The UK-based pharmaceutical group reported earnings per share up 18 per cent to 26.4p on the first quarter last year on sales up 9 per cent to £7.4bn - an increase of 13 per cent at constant exchange rates.

Andrew Witty, chief executive, said: "These results reinforce the fact that GSK is delivering a sustained performance . . . [showing] that our strategy is delivering." He played down the impact of US healthcare reform, saying the company had recovered from a sales fall last year on the back of patent expiries to report a 1 per cent first-quarter fall in turnover in the region.

Flu vaccine sales accoun-ted for much of the rise in overall sales, without which turnover rose 4 per cent to £6.6bn, with the company indicating that it expected full-year sales to be in line with last year in spite of a slump in demand as the swine flu outbreak proved more mild than feared.

GSK also revealed more detailed financial performance for each business unit for the first time, highlighting operating margins of 68 per cent for its US pharmaceuticals business, 60 per cent in Europe and 36 per cent in emerging markets.

In the quarter, GSK's vaccines arm generated margins of 54 per cent, consumer healthcare 16 per cent and dermatology 48 per cent, while GSK's ViiV Healthcare joint venture for HIV drugs with Pfizer had margins of 57 per cent.

While US pharmaceutical companies normally give less information, Nov-artis, the Swiss pharma group, reports some activities by operating division without providing a geographical split. Investors are braced for more wide-ranging information today when AstraZeneca reveals its performance product-by-product in emerging markets.

Gbola Amusa, a pharmaceuticals analyst with UBS, said: "GSK is heading in the right direction, but we model products by geographies, so what AstraZeneca does will be pivotal. I hope it won't be too long before GSK follows."


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