Obama: US aims to provide HIV drugs for extra 2 million by end of 2013

The United States will aim to provide antiretroviral treatment for 6 million people around the world by 2013, President Barack Obama announced today, increasing the original US target by 2 million.

The United States will also aim to provide antiretroviral drugs to prevent mother to child HIV transmission to 1.5 million women over the next two years, the President said. The US government also aims to support 4.7 million male circumcisions in eastern and southern Africa, and will fund the distribution of at least 1 billion male condoms.

The US government’s decision to increase its investment in antiretroviral treatment follows the results of the HPTN 052 trial, which showed that HIV treatment reduces the risk of transmission to a regular partner by around 96%.

Last month US Secretary of State Hillary Clinton said that the United States was now committed to a policy of creating an AIDS-free generation, and set the use of antiretroviral drugs at the heart of this strategy.

The new treatment target effectively doubles the pace of treatment scale-up through the US government’s President’s Emergency Plan for AIDS Relief (PEPFAR), and the commitment marks a significant turnaround from the Obama administration’s lukewarm attitude towards PEPFAR.

However, the Obama administration says that the expansion of treatment numbers will be achieved without requesting extra funds from Congress.

Instead, the scale-up in specific activities will be achieved through continuing cuts in drug prices and a reorganisation of resources to concentrate on high priority activities.

UNAIDS welcomed the renewed US commitment but highlighted the continuing shortfall in donor commitments to the Global Fund to Fight AIDS, Tuberculosis and Malaria.

The Global Fund announced last week that it has cancelled Round 11 of grant-making to national programmes, scheduled to support new applications from 2012 to 2014, due to lack of payments from donors who had promised money and the failure to make new pledges by other donors.

The Fund will now give money only to programmes already funded in order to allow them to continue providing treatment to people already enrolled.

While welcoming the new US commitment, activists called for swift action to deal with the cash crisis at the Global Fund.

 “We call on the U.S. and all donor countries to hold an emergency donor conference to ensure the Global Fund is open for new business—the business of ending AIDS—this year,” said Asia Russell, Director of International Policy for Health GAP.

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Earlier deaths in people with HIV due to drugs, alcohol, co-infections, poorly controlled HIV - not rapid ageing

Patients taking antiretroviral therapy have the same mortality risk as individuals in the general population, according to Danish research published in the open-access journal PLoS One. However, this was only the case when the patients responded to treatment and did not have other factors that increased the risk of serious illness and death, such as co-infections or co-morbidities, or drug and alcohol misuse.

“Mortality was associated mainly with well-known HIV and non-HIV-associated risk factors which are identifiable prior to or in the initial phase of HAART [highly active antiretroviral therapy] treatment,” comment the investigators. “Mortality in HIV-infected patients with no identifiable risk factors was almost identical to that of the general population with no risk factors.”

Effective antiretroviral therapy means that many HIV-positive patients have an excellent prognosis. Nevertheless, numerous studies have shown that the overall mortality risk of patients treated with anti-HIV drugs is still higher relative to that observed in the general population.

A number of reasons for this have been proposed including HIV-related illness, co-infections, lifestyle issues, treatment side-effects and accelerated ageing.

Danish investigators wanted to establish a better understanding of this important question.

They therefore designed a study with two aims. The first was to establish the impact on mortality of risk factors that could be identified at the time HIV treatment was started. The second was to estimate the relative risk of death for patients with and without such factors when compared to age- and sex-matched controls from the general population.

The study population comprised 2267 people aged between 25 and 65 who started HIV therapy between 1998 and 2010. The medical records of each patient were checked to see if they had risk factors that could increase the risk of death. These were divided into three broad categories:

Inadequate control of HIV. This was defined as a detectable viral load or a CD4 cell count below 200 cells/mm3.

Co-morbidities and co-infections.

Drug or alcohol abuse.

Each patients was matched with four HIV-negative controls from the general population.

Patients aged between 45 and 65 who had a good response to antiretroviral treatment and who did not have any co-morbidities/co-infections or drug/alcohol problems had a mortality risk ratio (MRR) of 1.14, comparable to that observed in the control population. The risk was somewhat higher for younger patients (25 to 45) who were doing well on therapy, but who had no additional risk factors (MRR = 2.02).

However, the risk of death was increased between four-fold and 20-fold for patients with either co-morbidities/co-infections or problems with drug/alcohol use.

“Increased risk of death was observed only in patients registered with one or more risk factors in the initial phase of HAART treatment,” emphasise the authors.

Individuals in the control group had an 88% probability of surviving until they were 65. The overall chance of survival to this age for patients with HIV was much lower at only 48%.

However, the probability of survival was massively affected by the presence of identifiable risk factors.

Patients with poor response to HIV therapy had a 58% chance of surviving until 65 years of age. This fell to 30% for patients with co-morbidities or co-infections, and to just 3% in those with high levels of drug or alcohol use.

In contrast, patients with none of these risk factors had a chance of survival to age 65 that was comparable to that seen in the general population (86 vs 88%).

“As we did not observe substantially increased mortality among HIV patients without risk factors, our data does not support the theory of premature ageing,” write the authors. “Rather, the data establish that the increased risk of death in the HIV population mainly stems from classic risk factors.”

They conclude: “Future management of the HIV-infected population should focus on early diagnosis, timely and effective HAART, and treatment of co-morbidity and alcohol/drug abuse.”

The authors also believe that it is important to give patients optimistic and accurate information about their potential prognosis, commenting: “Stressing the impact of HIV on mortality after HAART initiation may severely hamper the patients’ quality of life and be at odds with present data.”

View the original article here

Earlier deaths in people with HIV due to drugs, alcohol, co-infections, poorly controlled HIV - not rapid ageing

Patients taking antiretroviral therapy have the same mortality risk as individuals in the general population, according to Danish research published in the open-access journal PLoS One. However, this was only the case when the patients responded to treatment and did not have other factors that increased the risk of serious illness and death, such as co-infections or co-morbidities, or drug and alcohol misuse.

“Mortality was associated mainly with well-known HIV and non-HIV-associated risk factors which are identifiable prior to or in the initial phase of HAART [highly active antiretroviral therapy] treatment,” comment the investigators. “Mortality in HIV-infected patients with no identifiable risk factors was almost identical to that of the general population with no risk factors.”

Effective antiretroviral therapy means that many HIV-positive patients have an excellent prognosis. Nevertheless, numerous studies have shown that the overall mortality risk of patients treated with anti-HIV drugs is still higher relative to that observed in the general population.

A number of reasons for this have been proposed including HIV-related illness, co-infections, lifestyle issues, treatment side-effects and accelerated ageing.

Danish investigators wanted to establish a better understanding of this important question.

They therefore designed a study with two aims. The first was to establish the impact on mortality of risk factors that could be identified at the time HIV treatment was started. The second was to estimate the relative risk of death for patients with and without such factors when compared to age- and sex-matched controls from the general population.

The study population comprised 2267 people aged between 25 and 65 who started HIV therapy between 1998 and 2010. The medical records of each patient were checked to see if they had risk factors that could increase the risk of death. These were divided into three broad categories:

Inadequate control of HIV. This was defined as a detectable viral load or a CD4 cell count below 200 cells/mm3.

Co-morbidities and co-infections.

Drug or alcohol abuse.

Each patients was matched with four HIV-negative controls from the general population.

Patients aged between 45 and 65 who had a good response to antiretroviral treatment and who did not have any co-morbidities/co-infections or drug/alcohol problems had a mortality risk ratio (MRR) of 1.14, comparable to that observed in the control population. The risk was somewhat higher for younger patients (25 to 45) who were doing well on therapy, but who had no additional risk factors (MRR = 2.02).

However, the risk of death was increased between four-fold and 20-fold for patients with either co-morbidities/co-infections or problems with drug/alcohol use.

“Increased risk of death was observed only in patients registered with one or more risk factors in the initial phase of HAART treatment,” emphasise the authors.

Individuals in the control group had an 88% probability of surviving until they were 65. The overall chance of survival to this age for patients with HIV was much lower at only 48%.

However, the probability of survival was massively affected by the presence of identifiable risk factors.

Patients with poor response to HIV therapy had a 58% chance of surviving until 65 years of age. This fell to 30% for patients with co-morbidities or co-infections, and to just 3% in those with high levels of drug or alcohol use.

In contrast, patients with none of these risk factors had a chance of survival to age 65 that was comparable to that seen in the general population (86 vs 88%).

“As we did not observe substantially increased mortality among HIV patients without risk factors, our data does not support the theory of premature ageing,” write the authors. “Rather, the data establish that the increased risk of death in the HIV population mainly stems from classic risk factors.”

They conclude: “Future management of the HIV-infected population should focus on early diagnosis, timely and effective HAART, and treatment of co-morbidity and alcohol/drug abuse.”

The authors also believe that it is important to give patients optimistic and accurate information about their potential prognosis, commenting: “Stressing the impact of HIV on mortality after HAART initiation may severely hamper the patients’ quality of life and be at odds with present data.”

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Long-term use of HIV drugs is safe, does not raise risk of death, study shows

A large international study has provided persuasive evidence of the long-term safety of antiretroviral therapy. Writing in the online edition of AIDS, investigators from the EuroSIDA study report that prolonged use of antiretroviral therapy did not increase the risk of death from non-AIDS-related illnesses.

“The main finding of our study was that there was no evidence of an increase in the risk of any non-AIDS-related death with prolonged exposure to cART [combination antiretroviral therapy],” comment the authors. “The results are reassuring that so far prolonged use of cART does not appear to be leading to increased risk of death due to some previously identified cumulative effect, or a drug effect whereby there is a long induction period before disease appears.”

It is now well recognised that effective antiretroviral therapy has significantly improved the life expectancy of many patients with HIV.

However, all anti-HIV drugs can cause side-effects, and treatment with some has been linked to an increased risk of cardiovascular disease or kidney dysfunction. Whether prolonged treatment with antiretroviral therapy carries an increased risk of death from these and other diseases is currently unclear.

Therefore investigators from the EuroSIDA cohort study looked at the outcomes of approximately 12,000 patients who received potent combination antiretroviral therapy after 1996.

These patients were categorised according to the duration of treatment (under two years; two to three years; four to six years; six to eight years; and over eight years).

Overall mortality incidence was then calculated according to treatment exposure, as was the incidence of AIDS-related and non-AIDS-related deaths. The investigators adjusted their results to take into consideration factors known to independently affect prognosis including demographics, HIV risk group, co-infection status, CD4 cell count and viral load, and previous history of AIDS-related illnesses.

During 70,000 person years of follow-up, a total of 1297 patients died. A little over two-thirds of deaths (68%) were attributed to non-AIDS-related causes.

AIDS-related mortality accounted for 32% of all deaths. The investigators attributed 9% of deaths to non-AIDS-related infections, 14% to liver-related causes, 10% to non-AIDS-related cancers, 9% to cardiovascular causes, 7% to violence (including suicide) and 7% to other causes. In addition, 12% of non-AIDS-related mortality had an unknown cause.

Incidence of all-cause mortality was 18.3 per 1000 person years; AIDS-related mortality had an incidence of 5.85 deaths per 1000 person years; and the incidence of non-AIDS-related mortality was 12.5 per 1000 person years.

Further analysis showed that the incidence of all-cause mortality and AIDS-related mortality fell significantly as exposure to HIV therapy increased. However, the incidence of non-AIDS-related deaths remained broadly stable.

Each additional year of HIV therapy (after year two) was associated with a 5% reduction in the risk of all-cause mortality (p < 0.0001) and a 14% fall in the risk of AIDS-related deaths (p < 0.0001). The risk of non-AIDS-related deaths fell by 3% each year, a reduction that fell just short of significance (p = 0.06).

“Our analyses confirm the prolonged benefit of cART, with a 5% reduction in the overall risk of death per additional year on treatment, which was mostly attributed to a decrease in the risk of AIDS-related deaths.”

Prolonged use of antiretroviral therapy was also accompanied by a reduction in “the risk of liver-related death, violent, and unknown death.” The investigators speculate that the lower risk of violent death “could relate to stabilised health conditions, life-style changes or improvements in socio-economic status.”

However, longer duration of HIV therapy was accompanied by an increase in mortality attributed to non-AIDS-related cancers. The authors suggest this “may reflect aging of the HIV population…or improvement in cancer screening.”

They conclude: “It is clear that death due to accumulating treatment toxicities is a very uncommon event.”

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