Translating clinical efficacy into public health effectiveness

via Citizen News Service, by Bobby Ramakant

At the recently concluded XIX International AIDS Conference (AIDS 2012), not only the decibels went up on ending AIDS but also sane voices were heard demanding a well-costed and thought-through strategy on how to end AIDS. One of the strategies that will complement a comprehensive HIV prevention, treatment, care and support plan to end AIDS is preventing HIV transmission. In this context, we need to look beyond the Phase III trials in HIV prevention research so that if the product being tested is proved to be effective, we have the means and well-thought plan to make it available for those people in need, without delay.

The HIV prevention research is certainly going ahead with rectal microbicides phase II efficacy clinical trials (MTN017) about to begin in four countries (US, Thailand, South Africa and Peru), US FDA's approval to use 'Truvada' as pre-exposure prophylaxis (PrEP) for HIV prevention, vaginal microbicides research and HIV vaccine science progressing ahead, treatment as prevention (TasP) getting a buy-in as never before, among other positive developments that give us hope.

Read the rest.


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HIV and the Law

via the Commission on HIV and the Law

The end of the global AIDS epidemic is within our reach. This will only be possible if science and action are accompanied by a tangible commitment to respecting human dignity and ending injustice.

Law prohibits or permits specific behaviours, and in so doing, it shapes politics, economics and society. The law can be a human good that makes a material diff erence in people’s lives. It is therefore not surprising that law has the power to bridge the gap between vulnerability and resilience to HIV.

We came together as a group of individuals from diverse backgrounds, experiences and continents to examine the role of the law in effective HIV responses. What we share is our abiding commitment to public health and social justice. We have listened with humility to hundreds of accounts describing the eff ects of law on HIV. In many instances, we have been overwhelmed by how archaic, insensitive laws are violating human rights, challenging rational public health responses and eroding social fabric. At other times, we have been moved by those who demonstrate courage and conviction to protect those most vulnerable in
our societies.

Many would say that the law can be complex and challenging and is best left alone. Our experience during this Commission has shown us a very diff erent perspective. We have been encouraged by how frank and constructive dialogue on controversial issues can sometimes quickly lead to progressive law reform, the eff ective defence of legislation or better enforcement of existing laws. Even in environments where formal legal change is a slow and arduous process, we have witnessed countries taking action to strengthen access to justice and challenge stigma and discrimination.

Click here for the full report.


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South Africa: Aids Response Must Be Guided By Human Rights and Justice

via allAfrica, by Festus Mogae and Stephen Lewis

In South Africa and across Africa, HIV continues to prey on women, sex workers and men who have sex with men. It is clear that to end the HIV epidemic, we must protect and support these groups.

Archaic laws and customs make women and girls more vulnerable to HIV. Legally condoned violence and oppression-including genital mutilation, sexual violence, denial of property rights and early marriage- undermine the ability of women to protect themselves. Laws urgently need to protect women, who are often the ones left to care for the sick, tend to the family and till the fields.

Laws across the continent also criminalize homosexuality. Yet, punishing men who have sex with men force them into secrecy. They are unable to access counseling and testing, making it almost impossible for HIV prevention and treatment interventions to reach them. In 2008, when the Senegalese government jailed nine gay HIV outreach workers under a law prohibiting "acts against nature," health workers went into hiding, advocacy groups disbanded and HIV treatment sites were shut down.

The time has come for African leaders to take action against bad laws that stifle our HIV response. We must challenge societal values rooted in fear and prejudice and implement laws based on human rights and sound public health.

Read the rest.



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Clinical Trials Have Gone Global: Is This a Good Thing?

via plosmedicine.org, by Trudie Lang and Sisira Siribaddana

Why Do We Need Trials and What Makes a Trial a Trial?

Clinical trials are needed globally to reduce disease burdens by helping developing safe and effective new therapies and vaccines. These solutions may be for non-communicable diseases like cancer and diabetes, or, as is especially needed in the poorest regions of the world, infectious disease. Developing countries are under-represented in research due to lack of commercial viability and trained researchers, yet it is in these poorest regions where research-led solutions could bring the greatest impact to high rates of early mortality.

As a research tool clinical trials are fundamental in the effort to develop new products by gaining the data required by regulators, whether for product license extensions for existing therapies for common ailments or to bring cutting edge new therapies and vaccines into approved use. However, there is also a need for clinical trials to bring evidence to determine how to improve the management of health issues; these studies often do not involve a medicinal product but instead compare different options, such as different types of management of an illness in hospital with community-based care. Or, for example, a clinical trial might be used to assess different mechanisms to improve patient adherence to therapy. These pragmatic disease management trials can bring about significant improvements in public health and often require large yet simple trial designs.

The World Health Organization and journal editors define clinical trials as “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes” [1]. Patients may be randomised to an intervention involving either an investigational new product or the standard-of-care treatment, or the patient might be randomised to be cared for by nurses who have been trained in one of two or more comparative ways.

Read the rest.


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Antiretroviral Prophylaxis for HIV Prevention Reaches a Key Milestone

via Lancet.com, by Salim S Abdool Karim  and Quarraisha Abdool Karim

On May 10, 2012, a US Food and Drug Administration (FDA) advisory committee voted in support of the use of tenofovir-emtricitabine for HIV prevention.1 If the FDA, which is scheduled to make its decision by June 15, adopts the committee's recommendations, tenofovir-emtricitabine will become the first antiretroviral drug to be approved as pre-exposure prophylaxis (PrEP) for the prevention of HIV, paving the way for implementation.

PrEP has a unique advantage in young women in southern Africa, who bear a disproportionate burden of the HIV epidemic. In much of this region, young women are often unable to convince their male partners to use condoms, remain faithful, or have an HIV test. To rely on her HIV- positive discordant male partner to come forward to test, to agree to take antiretroviral therapy (ART), and to take his ART with high adherence, all for her protection, puts a woman's risk of acquiring HIV back in the hands of men, thereby disempowering women and undermining their efforts to control their risk of HIV.

However, there are several criticisms and concerns about PrEP. First, that data on the effectiveness of PrEP, especially in women, are inconsistent. This concern is based on the results of two PrEP studies—the FEM-PrEP2 and VOICE3, 4 trials—which were stopped, at least partly, earlier than planned when they did not show efficacy. To some extent, this concern has been allayed by recent data from the FEM-PrEP trial5 which show that adherence to daily tenofovir-emtricitabine in the trial was too low allow assessment of efficacy. Data to explain the VOICE trial, which still has an ongoing tenofovir-emtricitabine group, are not expected until 2013.

Second, some suggest that antiretroviral drugs should be provided to HIV-negative people only when all eligible HIV-positive patients are receiving ART. Although it is a legitimate concern that eligible HIV-positive patients should be prioritised for ART for their own health and to save their lives, it is spurious to trade off treatment and prevention as if these drugs are being taken away from sick and dying patients to be given to healthy people. Treatment and prevention strategies are a continuum in their use of antiretroviral drugs—both are needed in conjunction with each other to ensure ART provision is sustainable in the long term and to realise the quest to end the HIV epidemic.

Read the Rest.


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aidsmap: HIV treatment may be stabilising HIV epidemic in Danish gay men

via aidsmap, by Michael Carter

Excerpt:

Danish safe-sex poster from '89

“While unsafe sex among MSM [men who have sex with men] has increased substantially and the number of HIV-positive MSM living in Denmark has enlarged, the incidence of HIV diagnoses in this population has remained stable for more than a decade,” write the authors. “Our findings indicate that this paradox is due to effective antiretroviral therapy and not increased awareness of safe sex.”

Read the rest.



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The Challenges that Arise When Using ARV's as HIV Prevention

via AIDSmeds, by Tim Horn


Excerpt:

A key question from HPTN 052 is whether the results can be generalized to other contexts, Cohen and his colleagues explain. Examples include heterosexual couples with CD4 counts lower and higher than those studied in HPTN 052; high-risk heterosexual individuals, notably sex workers and their clients; men who have sex with men (MSM); and injection drug users (IDUs).

With regards to MSM and IDUs, the authors note, a World Health Organization expert committee concluded that there is no reason to presume that treated, HIV-positive MSM will not be rendered less contagious as a result of ARV therapy. “However,” Cohen and his colleagues write, “the biology of HIV transmission is sufficiently different in IDU and MSM as compared to heterosexual transmission, warranting further consideration and study.

“For example, the number of HIV variants acquired and the efficiency of transmission are higher in MSM and IDU than in heterosexual transmission,” they note in recalling one study. “Additionally, whether [ARV therapy] reduces infectivity through anal sex by the same order of magnitude as for vaginal sex remains uncertain. Although such an effect is widely assumed, this is a key missing piece of evidence.”

Read the rest.

 
[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

HIV/AIDS Treatments Compromised by Budget Cuts

via Nature News, by Erika Check Hayden

Preventing the spread of HIV used to mean testing people for infection and encouraging them to practise safe sex. Increasingly, it also means prescribing drugs, as studies show that giving infected people or their uninfected partners antiretroviral drugs as soon as an infection is diagnosed can help to check the spread of AIDS.

Yet at this week’s annual Conference on Retro­viruses and Opportunistic Infections in Seattle, Washington, there was growing concern that financial austerity in the United States and elsewhere is eating away at the funding needed for a worldwide prevention effort.

Many scientists and advocates agree that there is now an “awesome possibility to prevent the spread of HIV”, says Sharonann Lynch, HIV policy adviser for Médecins Sans Frontières (MSF, also known as Doctors Without Borders) in New York. “If we decrease the money invested in treatment now, we are squandering the best opportunity we’re going to have to get ahead of the wave of new infections.”

Last month, US President Barack Obama’s 2013 budget request proposed a 10.8% cut to direct international aid for HIV programmes under the President’s Emergency Plan for AIDS Relief (PEPFAR) which, together with previous cuts, would slice more than US$1 billion from the fund’s 2010 level (see ‘Sliding support’). And last November, the Global Fund to Fight AIDS, Tuberculosis and Malaria said that it would not hand out any more funds for scaling up AIDS treatments until 2014 because of tightening budgets in donor countries (see Nature 480,159–160; 2011).

The shortfalls come as a slew of results presented this week reinforce a growing consensus about the power of early treatment for HIV infections. The latest data are part of a trend that accelerated last May, when HPTN 052, a clinical trial run by the multinational HIV Prevention Trials Network, showed that giving antiretroviral drugs to people who are HIV-positive can stop them from passing the virus to their uninfected partners (M. S. Cohen et al. N. Engl. J. Med. 365, 493-505; 2011). In light of such results, the World Health Organization is expected to issue new guidelines for managing HIV in couples soon.

Read the Rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

CROI 2012: iPrEx Researchers Test Dosage of PrEP

via AidsMap.com, by Gus Cairns

Further testing of drug levels in the blood and immune cells of gay men participating in the iPrEx trial of tenofovir/FTC (Truvada) pre-exposure prophylaxis (PrEP) has found that HIV infection in men assigned to Truvada was associated with a lapse in taking the drug after initially adhering reasonably well, rather than never having taken it at all, which was what the researchers originally thought. The research was presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI), in Seattle.

The testing also found that only a minority of participants appeared to be taking their drugs as prescribed, seven days a week, but that protection levels were very high – in the order of 96% of infections prevented – as long as participants took four or more doses a week.

Drug levels plummet three months before infection

The results of iPrEx, a large multi-country study of PrEP in gay men, were announced in 2010 and showed an overall efficacy of 42% – in the trial subjects as a whole, four out of ten HIV infections that would otherwise have happened were prevented if subjects were given Truvada pills to take daily rather than placebo pills. When drug levels were tested in the 48 participants who became HIV-infected on Truvada, and a random sample of uninfected participants, it was found, perhaps not surprisingly, that drug was detectable in only 10% of the infected participants but also, perhaps more surprisingly, in only 50% of the uninfected ones.

New measurements have now looked back at drug levels in stored samples in the months prior to infection and compared with drug levels in the same time period in uninfected participants. In the uninfected participants, consistently 45% or so had detectable drug in their samples across the whole length of the study – confirming that at least half of the participants simply never took their pills. In the infected participants average adherence rates started off the same as in the uninfected. They showed a slight decline in the first year of the trial but then declined to 10% in the three months preceding infection. This suggests a role for quarterly adherence reinforcement.

What levels of tenofovir are protective?

The researchers also wished to find out what levels of tenofovir in the blood were associated with protection against HIV. They did this by comparing drug levels in iPrEx participants with drug levels in a small study called STRAND, presented at last year’s conference (Liu),which gave participants directly-observed doses of tenofovir twice, four time or seven times a week and then measured drug levels in their hair. By then comparing the levels of protection seen in participants with specific drug levels in iPrEx, the researchers were able to compute what drug level was protective.

In iPrEx the average drug levels seen in infected people were consistent with less than one dose of tenofovir a week, but drug levels in those who were not infected were consistent with only about three doses a week. Only 18% of iPrEx participants had drug levels consistent with taking seven doses a week. The investigators used very sensitive tests to look at levels of metabolised tenofovir inside cells and found that a reduction of 90% in the risk of HIV infection correlated with a drug level of 16 femtomols per mol (fm/M – 16 in every million billion molecules by weight). The average level associated with seven doses a week in STRAND was about 38 fm/M and with four doses a week about 32 fm/M.

This enabled them to calculate that the protection offered by taking four doses of tenofovir a week was high, and more or less the same as taking seven doses – that is, in the order of 96%, with a minimum likely protectiveness of 90%. They also calculated that absolutely perfect adherence would offer 99% protection. Taking two doses a week (consistently) would still offer 72% protection, though within wide confidence intervals (56% to 96%) while the 42% level of protection actually seen in iPrEx was consistent with participants taking, on average, one dose a week.

This study has important limitations. STRAND did not measure FTC levels so the iPrEx researchers could not calculate what extra protection was offered by that drug. They also could not measure drug levels at the actual moment of exposure – they were measured at anything between 15 and 90 days after infection. And of course the ‘number of doses a week’ measure is purely an average – most participants probably had much more irregular patterns of taking their pills, with (amongst the 50% who took it at all) periods of good adherence interspersed by periods off drug, maybe correlated with times on and off sex. But it does give a guide to the likely minimum levels of tenofovir that people need to maintain in order to be protected from HIV.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Condoms Still a Fundamental Prevention Method

viaCSIRO Publishing, by Richard Crosby and Willard Cates Jr.

The global pandemics of HIV, sexually transmitted infections (STIs) and unintentional pregnancy clearly necessitate innovative prevention strategies. Although recent biomedical approaches such as antiretroviral (ARV) treatment for persons living with HIV,3 ARV pre-exposure prophylaxis (PrEP) for HIV-negative people at risk of acquisition4–6 and adult male circumcision7,8 programs are valuable assets against the spread of HIV, these biomedical strategies are not a panacea. Moreover, their associated costs are sizeable.9

Condoms are the oldest and most affordable method of HIV prevention. Recent advances in knowledge about the nuances of this method have been spawned by the AIDS pandemic. These condom innovations are not always product-oriented; indeed, most involve harnessing the behavioural and social sciences to promote improved frequency and quality of condom use, especially among those at greatest risk.

This special issue of Sexual Health provides state-of-the-art reviews of recent research on both male and female condoms. More importantly, it builds upon the foundation of ‘what we know’ to offer concrete future directions for optimal public health impact. Even today, condom use remains a fundamental prevention practice for both the HIV and STI pandemics, as well as the ongoing global problem of unintentional pregnancy.

The issue opens with Warner and colleagues11 making an eloquent case that condom use is a complex behaviour, embedded in the fabric of gender inequalities. They highlight the need for creative programs to rectify issues that users experience with condoms. They offer a scenario – however utopian – where condom use could be perceived as pleasurable. Indeed, a population-level, sex-positive approach to promoting condom use is an aspirational aspect of this opening commentary. It also touches upon the empirical question of condom effectiveness, an issue dealt with at length in the subsequent article.

Rather than being an exhaustive review of the extant literature, the condom effectiveness review captures the immensely complicated challenges inherent in studies of human sexual behaviour. Prospective observational studies offer a relatively strong body of evidence supporting condom effectiveness even in the presence of the multiple forms of bias towards the null. This suggests that our current condom effectiveness estimates are usually understated. The review concludes that consistent and correct use of condoms is highly effective in protecting against STIs, HIV and unintended pregnancy.

Read the Rest.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

PrEP: Attitudes and Acceptance Among Potential User Groups

via PLoS One, by Andreas B. Eisingerich, Ana Wheelock, Gabriela B. Gomez, Geoffrey P. Garnett, Mark R. Dybul, Peter K. Piot

Background

The use of antiviral medications by HIV negative people to prevent acquisition of HIV or pre-exposure prophylaxis (PrEP) has shown promising results in recent trials. To understand the potential impact of PrEP for HIV prevention, in addition to efficacy data, we need to understand both the acceptability of PrEP among members of potential user groups and the factors likely to determine uptake.

Methods and findings

 Surveys of willingness to use PrEP products were conducted with 1,790 members of potential user groups (FSWs, MSM, IDUs, SDCs and young women) in seven countries: Peru, Ukraine, India, Kenya, Botswana, Uganda and South Africa. Analyses of variance were used to assess levels of acceptance across different user groups and countries. Conjoint analysis was used to examine the attitudes and preferences towards hypothetical and known attributes of PrEP programs and medications. Overall, members of potential user groups were willing to consider taking PrEP (61% reported that they would definitely use PrEP). Current results demonstrate that key user groups in different countries perceived PrEP as giving them new possibilities in their lives and would consider using it as soon as it becomes available. These results were maintained when subjects were reminded of potential side effects, the need to combine condom use with PrEP, and for regular HIV testing. Across populations, route of administration was considered the most important attribute of the presented alternatives.

Conclusions

Despite multiple conceivable barriers, there was a general willingness to adopt PrEP in key populations, which suggests that if efficacious and affordable, it could be a useful tool in HIV prevention. There would be a willingness to experience inconvenience and expense at the levels included in the survey. The results suggest that delivery in a long lasting injection would be a good target in drug development

Read the full study here.



[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Treatment outcomes among different ethnic groups similar for UK gay men

via Aidsmap, by Michael Carter

HIV treatment outcomes among gay men in the UK are similar across ethnic groups, investigators report in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The study showed that gay men from black and minority ethnic (BME) populations were approximately 17% less likely to initiate antiretroviral therapy than white gay men. However, after starting treatment there were no differences by ethnicity in treatment outcomes.

“The provision through the NHS [National Health Service] of publicly funded HIV care with universal access has resulted in equitable utilisation and outcomes of HIV care across different ethnic MSM [men who have sex with men] groups,” comment the investigators. “Nevertheless we have shown that there are disparities in the uptake of cART [combination antiretroviral therapy] and the reasons for this warrant further study.”

Gay men remain one of the groups most affected by HIV in the UK. Prevalence of the infection differs significantly according to ethnicity and is higher among BME gay men compared to white gay men.

US research showed that differences in health insurance status meant that MSM from minority racial populations were less likely to access healthcare compared to white MSM.

In the UK, however, the NHS provides universal and equitable access to healthcare. Despite this, there is some evidence suggesting that BME patients are more likely to report dissatisfaction with their care and longer waiting times for appointments.

Investigators from the UK Collaborative HIV Cohort (UK CHIC) therefore analysed differences in retention in HIV care, uptake of antiretroviral therapy and HIV treatment outcomes between MSM according to ethnicity.

The study involved 16406 gay male patients who received care between 1996 and 2008. The analysis of HIV treatment utilisation was restricted to individuals who were seen after 2000. Examination of treatment outcomes was restricted to the subgroups of individuals who received care after 2007.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Beliefs associated with unprotected sex are changing among gay men in Australia

via Aidsmap, by Roger Pebody

A study of Australian gay men examining unprotected sex and the beliefs that are associated with it has found that the concept of ‘treatments optimism’ needs to be unpacked. While some men do think that having HIV is less serious than it used to be, there is more of an association between unprotected sex and men believing that treatments have made HIV-positive people less infectious.

But writing in the journal Sexually Transmitted Diseases, the researchers warn that the relationships between information, beliefs and behaviour are not straightforward, with individuals managing risk, desire and pleasure in complex ways.

Soon after the advent of combination therapy, commentators began to explain unprotected sex in gay and bisexual men in terms of ‘treatments optimism’ – the theory that reductions in illness and death had caused men to be less concerned about HIV infection, and so more willing to have unprotected sex. While a number of studies have confirmed an association between beliefs characteristic of treatments optimism and risk behaviour, it is unlikely that such beliefs – held by a minority of men – are sufficient to explain rising infection rates in gay men.

Moreover, there has always been controversy over whether treatment optimism leads to unprotected anal sex, or whether it is a way in which men rationalise their sexual behaviour, after the event.

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Non-communicable diseases (NCDs) and HIV fight for resources in Kenya

via PlusNews Global

"NCDs are sexy now, last year it was maternal health; there doesn't seem to be a genuine commitment by government to fully address any of these issues... where are the results? The government must not forget about people living with HIV," said James Kamau, coordinator of the Kenya Treatment Access Movement. "Where is the 15 percent they promised - that way, we could improve treatment of all illnesses."

The crowd of health issues jostling for a share of Kenya's inadequate health budget is expanding, with activists calling for an increase in resources for the management of non-communicable diseases (NCDs), which account for more than 50 percent of hospital deaths and admissions.

"We need to see more commitment in terms of resources; we have policies and guidelines for the management of non-communicable illnesses, but we need strategic focus on operational implementation," said Andrew Suleh, medical superintendent of Mbagathi District Hospital in the Kenyan capital, Nairobi.

According to the NGO, NCD Alliance, NCDs are responsible for more than half of all hospital admissions and deaths; 13 percent of deaths are due to cardiovascular disease, while cancers account for 7 percent and diabetes for 4 percent of deaths, respectively.

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[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Plasma and rectal viral load correlated in HIV-positive gay men: supports use of treatment as prevention

via European AIDS Treatment Group, by Michael Carter

Viral load in the blood and rectal secretions of HIV-positive gay men are highly correlated, according to US research published in the September 1st edition of the Journal of Infectious Diseases. The study also showed that the presence of sexually transmitted infections did not increase rectal viral load.

Individuals with a plasma viral load above 1000 copies/ml were significantly more likely to have detectable virus in the rectum.

“Our data add substantially to the few published studies of HIV shedding in rectal secretions of MSM [men who have sex with men],” comment the investigators, “we were able to quantify HIV RNA in rectal secretions, demonstrate the linear correlation between increasing plasma load and rectal viral load and determine a threshold plasma viral load that distinguished detectable from undetectable rectal viral load.”

They also believe that their findings have important implications for current debates about the use of HIV treatment as prevention, commenting: “Combination antiretroviral therapy will have a similar effect on reducing HIV transmission in MSM, as seen in studies of heterosexual discordant couples.”

Read the rest.


[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Legal Case in India Threatens HIV Drug Access for Poorest

via The Bureau of Investigative Journalism, by Melanie Newman

"India is literally the lifeline of patients in the developing world, especially in the poorest parts of Africa…If Sec. 3(d) is overturned, it means any meaningful effort to make these vital medicines available will be put in jeopardy."

A technical case going through the Supreme Court in India is being carefully watched by aid agencies and other human rights organisations, who claim it could have severe consequences for the supply of lifesaving drugs to the developing world.

More than 90% of drugs used to treat children with AIDS in Africa come from Indian generic manufacturers, according to the medical NGO Medicins Sans Frontieres. And if the Swiss pharmaceutical giant Novartis wins a case it has brought against the Indian government, MSF fears that supply could dry up.

Novartis is seeking patent protection for its leukaemia drug Glivec, whose patent has expired in India. It is challenging India’s interpretation of a section of the nation’s patent law — Section 3(d) — which prevents ‘evergreening’.

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

How Much Would it Cost to End AIDS?

via Bloomberg, by Simeon Bennet

Michel Kazatchkine and Eric Goosby may be able to halt the spread of HIV. They just need the money.

The two men control the funds that buy drugs for most of the world’s AIDS patients. Studies in July provided the strongest evidence yet that medicines used since 1994 to treat HIV can almost eliminate the chance an infected person will pass the virus to a sex partner. Given to healthy people, the treatments can also protect against infection, offering the potential to end a pandemic that has killed 30 million people in 30 years.

Governments are now planning projects to assess whether those findings can be replicated in the real world, and what that might cost. Getting the drugs just to those patients who should be treated under existing guidelines would cost another $6 billion a year, according to the United Nations. Treating all those infected, in some of the world’s poorest countries, would cost tens of billions more.

Finding more money will be difficult with economic growth stalling and nations including the U.S., the biggest donor to the AIDS fight worldwide, trying to curtail overall spending to rein in debt. Funding for AIDS in poorer nations fell 10 percent to $6.9 billion in 2010 from 2009 levels, according to the UN.

“We may well be able to overcome AIDS,” Kazatchkine, the director of the Geneva-based Global Fund to Fight AIDS, Tuberculosis and Malaria, said in an interview. Still, “the gap between what the science is telling us we can achieve and what we would be able to achieve is at risk of increasing.”

Read the rest.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

Early ARV Treatment Will Save Lives in South Africa

Via All Africa.

Government's decision to offer free ARV treatment to people with CD4 counts of 350 or less has been welcomed as a life-saver.

The South African government's announcement that it will give antiretroviral medication to people with HIV who have CD4 counts of below 350 will save lives and prevent infection.

This is according to Medecins Sans Frontieres (MSF), which welcomed the announcement made by Deputy President Kgalema Motlanthe on Friday (12 August).

Until Friday, people were only able to get ARVs if their CD4 count was below 200 unless they were pregnant or had tuberculosis.

"The decision to start people on HIV treatment earlier, before they become sick with diseases like tuberculosis, marks a critical moment for this country that is so hard hit by the epidemic," said Dr Gilles van Cutsem, Medical Coordinator for MSF in South Africa.

"When people are started earlier on ARV treatment, they are less likely to die, less likely to become ill, less likely to need hospitalisation and more likely to stick to their treatment in the long run."

A study conducted by MSF last year in Lesotho found that patients who started treatment above CD4 200 were 68% more likely to survive than patients those who started ARVs when their CD4 count was below 200.

Van Cutsem added that starting people on ARVs earlier was likely to prevent new infections as "ARV treatment dramatically reduces the spread of the virus to others, by making people living with HIV less infectious by up to 96 percent".

Meanwhile, a study published in PloS journal in July predicts that making ARVs available to people from CD4 of 350 would have a dramatic effect on the community of Hlabisa in northern KwaZulu-Natal.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

The crazy things they say: politicians and HIV

Via PlusNews.

Political commitment is key to the success of HIV programmes and African leaders have been at the forefront of the fight against HIV on the continent, but politicians also have the power to harm HIV/AIDS campaigns.

Uganda's recently appointed health minister, Christine Ondoa, has been berated by AIDS activists for comments she allegedly made in an interview with a local newspaper on 1 August. According to The Observer, Ondoa claimed to know three people who had been cured of HIV through prayer.

"I am sure and I have evidence that someone who was [HIV] positive turned negative after prayers," she said.

Activists described her comments as "careless and misleading". Ondoa joins a long list of African leaders who have been criticized for comments deemed detrimental to the fight against HIV; here are some of the more controversial statements made by politicians:

Thabo Mbeki - In 1999, the then South African president said the ARV zidovudine - also known as AZT - had toxic side-effects and was dangerous to health, and as such, the government would not provide it free of charge to HIV-positive pregnant women.

Mbeki stirred controversy when he questioned the causal link between HIV and AIDS; in 2000 he set up a Presidential AIDS Advisory Panel, largely comprising AIDS denialists, to discuss how South Africa should deal with the crisis.

Mbeki also evoked conspiracy theories by alleging that the US Central Intelligence Agency, working with large pharmaceutical companies, was part of a conspiracy to promote the view that HIV caused AIDS.

In 2001, the NGO Treatment Action Campaign (TAC) filed a lawsuit against the government aimed at giving HIV-positive pregnant women access to the ARV, nevirapine, used to reduce the risk of HIV transmission from mother to child. TAC won the case, and the government was forced to provide the drug through the public health system.

According to the authors of a 2008 Harvard study, more than 330,000 lives were lost as a result of the delays in implementing a feasible and timely ARV treatment programme in South Africa.

Manto Tshabalala-Msimang - South Africa's health minister from 1999 to 2008 under Mbeki, her years in office were characterized by controversy, largely due to her reluctance to develop public sector policies involving the use of ARVs to fight AIDS.

Even after ARVs became available, Tshabalala-Msimang continued to cast doubt on their safety and efficacy, actively endorsing alternative therapists who promoted scientifically untested alternatives to ARVs.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]

More in Uganda: Minister Comments Carelessly on HIV/AIDS

Via In2EA.

The Health Minister Christine Ondoa’s remarks that HIV/Aids can be cured through prayer have not been received well by both health practitioners and born-again preachers who called it careless and misleading remarks.

Yesterday, Ms Ondoa was quoted by the Observer newspaper to have had a firsthand experience with people she claimed were infected by the HIV/Aids virus but after a series of prayer, tested negative.

She, however, observed that medical workers and the general public should be cautious about people who claim they were healed of HIV, adding that as a scientist she is often careful not to automatically believe a person who comes to her presenting negative results after being prayed for. Such a person’s sero status must be checked and their medical records that show they tested positive must be scrutinised, Ms Ondoa added.

The Head of The Aids Support Organisation (TASO), Mr Richard Ochai, who refused to believe that a minister could say such a thing, said such statements, most especially from born-again churches, are continuously curtailing TASO efforts to fight against HIV/Aids whose prevalence in recent years is said to have increased in the country.

He said science has proved that if one takes ARVs the viral load will become low such that they may not be detected but once they stop taking the drug, the virus will definitely be seen again. “We know God can do miracles if he so wishes but these many possibilities still need scientific prove,” Dr Ochai said.

Read the rest here.

[If an item is not written by an IRMA member, it should not be construed that IRMA has taken a position on the article's content, whether in support or in opposition.]