Medicines Control Council Delays HIV Drug Trials in South Africa

via allAfrica.com, by Marian Shinn of the Democratic Alliance

For the past year two applications for field trials have been awaiting approval by the MCC. One is from the Centre for the Aids Programme of Research in South Africa (CAPRISA) for the second field trial of its world-acclaimed antiretroviral vaginal gel.

The second is from the University of the Western Cape-based International Centre for Innovation Partnerships for a field trial of a drug that could delay the onset of AIDS in HIV positive people. This drug is a breakthrough in the use of active extracts from the Sutherlandia indigenous plant.

Both these drug developments are funded, in part, by the Department of Science and Technology (DST).

A year ago CAPRISA's Tenofovir gel received world-wide scientific recognition based on the results of the successful pioneering field trial held in KwaZulu-Natal. In November 2010 the developers of this microbicide gel applied to the MCC for permission to launch a second field trial that would include women attending family planning clinics in KwaZulu-Natal.

Many of these women took part in the first trial and, since that first ended in March 2010, have been prevented from continuing to use the preventative gel because CAPRISA cannot obtain permission to start its new trial, for which about R28 million in funding from UNAids and the DST has been secured.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

The Latest Treatment Action Campaign (TAC) Briefing - Antiretrovirals and Prevention

via Treatment Action Campaign, by Catherine Tomlinson and Nathan Geffen

Exciting new evidence has demonstrated the potential of antiretroviral medicines (ARVs) to prevent HIV from being sexually transmitted. This TAC briefing explains the evidence and then discusses policy implications. 

 

Our recommendations

1. The WHO must release its guidelines on serodiscordant couples.
2. People living with HIV should be offered highly active antiretroviral treatment (ART) when their CD4 counts fall below 350 cell/mm3, or if they have an AIDS illness or TB.
3. HIV-positive people in serodiscordant couples should be offered ART irrespective of their CD4 count.
4. For serodiscordant couples trying to conceive, both partners should be offered ARVs until conception is confirmed, after which the HIV-positive partner should continue on ART.
5. Pre-exposure prophylaxis (PrEP) should be made available to sex workers.
6. In other cases, pre-exposure prophylaxis should be made available to HIV-negative people who request it or who will --in the opinion of their nurse or doctor-- likely benefit from it.
7. The rollout of ARVs for prevention must not divert funding away from treatment programmes. Achieving universal access for people with HIV must remain the priority for governments, policy makers and funders.
8. Effective prevention interventions such as voluntary medical male circumcision and ensuring availability of male and female condoms continue to be critically important.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Analysis: Legal case in India threatens HIV drug access for poorest

via The Bureau of Investigative Journalism, by Melanie Newman

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’.

Evergreening is a common method used by drug companies to extend the life of their patents. They make slight alterations to the basis molecule every few years and apply for fresh patents for the amended versions, which then prevents generic copies of the drugs being made.

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

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.”

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[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]

Cost-effectiveness of PrEP

via Nature Medicine, by Roxanne Khamsi

Clinical trial data are starting to pour in demonstrating that the HIV prevention strategy known as 'pre-exposure prophylaxis' is an effective way of keeping people at high risk of infection disease free. In July, researchers reported at the International AIDS Society Conference in Rome that taking an antiretroviral drug called Truvada offered a 73% protection rate for heterosexual couples in East Africa in which only one person had HIV. At the same meeting, the US Centers for Disease Control and Prevention also announced trial results demonstrating a 63% reduction in transmission among young adults in Botswana taking the pill.

Buoyed by these and similar findings reported last year among men who have sex with men, health policy experts and economists are now debating how best to roll out the strategy to those who might benefit most. Preliminary analyses, experts say, indicate that PrEP should be a cost-effective tool to address the HIV epidemic until more testing and treatment for the disease becomes available.

Last year, even before PrEP was known to be effective for heterosexuals, a team led by Carel Pretorius of the Futures Institute, a global health think tank based in Glastonbury, Connecticut, published a mathematical model assessing the resources needed to apply it. The analysis concluded that administering PrEP to young South African women could—in an optimistic scenario—prevent up to a quarter of all new cases of HIV in the targeted high-risk age group at a cost of as little as $12,500 per each averted infection. The model asserts that this constitutes a worthwhile investment, as long as the reach of antiretroviral treatment for HIV-positive individuals remains low in the country (PLoS ONE 5, e13646, 2010).

In a similar vein but using a different cost metric, Rochelle Walensky, from Harvard Medical School in Boston has unpublished evidence showing that each year of life saved due to PrEP among a comparable South African cohort should cost just $3,600 when taking into account all downstream survival benefits and costs. That price would be considered by the World Health Organization to be “very cost-effective” since it falls well below the country's average annual per capita gross domestic product.

“There were so many people who expected us to say, 'Prove it's cost saving,'” says Walensky. “I thought that was a tall order, but I thought it would likely be cost effective.”

In certain settings, PrEP can cost around $250 per year for a full dose of daily pills and the associated HIV testing and laboratory monitoring. That may sound cheap, but, given shrinking global health budgets around the world, researchers worry about whether the pills will find their way to those who need them most. “Things can be cost effective and even cost saving, but you've still got to find a big lump of cash,” says Timothy Hallett, who studies resource allocation for HIV at Imperial College London.

Even with adequate funding, however, experts emphasize the moral imperative to assure access to medications for people known to carry the virus before giving limited drug supplies to those not yet infected. “I don't see how we could treat uninfected people without first treating infected people,” says Arleen Leibowitz, a health economist at the University of California–Los Angeles.

But, outside the developing world, Leibowitz thinks that those willing to pay out of pocket for the drugs should have that option. “I would not deny PrEP to anyone who would be able to pay for it,” she says. “If you want to do this with your money, that's perfectly legitimate.”

[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]