Mapping Pathways is a multi-national project to develop and nurture a research-driven, community-led global understanding of the emerging evidence base around the adoption of antiretroviral-based prevention strategies to end the HIV/AIDS epidemic. The evidence base is more than results from clinical trials - it must include stakeholder and community perspectives as well.

Showing posts with label WHO. Show all posts
Showing posts with label WHO. Show all posts

20 July 2012

HIV/AIDS: WHO issues guidelines on PrEP

via PlusNews

NAIROBI/KAMPALA, 20 July 2012 (PlusNews) - Days after US officials gave unprecedented approval for the use of an antiretroviral drug by HIV-negative people to reduce the risk of their acquiring the HI virus, the World Health Organization (WHO) has issued guidance to governments on so-called pre-exposure prophylaxis (PrEP).


WHO's guidelines, which call for a cautious and gradual roll-out, will likely see many countries begin to add PrEP to the growing arsenal of tools in the fight against HIV.

The guidance is based on evidence from clinical trials on the daily use of ARVs for HIV prevention among high-risk HIV-negative people. A 2010 study - Iniciativa Profilaxis Preexposicion, or Prexposure Prophylaxis Initiative (iPrEX) - among men who have sex with men (MSM) and transgender people, found that a daily dose of the ARV, Truvada - a combination of emtricitabine and tenofovir disoproxil fumarate - reduced HIV infection risk by about 42 percent.

The 2011 Partners PrEP study in Kenya and Uganda concluded that a daily dose of Truvada, taken by the HIV-negative partner in a heterosexual HIV-discordant relationship - where one sexual partner is infected and the other is not - could reduce the risk of HIV transmission by up to 75 percent.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

WHO issues first guidance on use of antiretrovirals by HIV-negative people at high risk to prevent infection


World Health Organization20 JULY 2012 | GENEVA / WASHINGTON DC - WHO has issued its first guidance to countries that are considering offering HIV medications, known as antiretrovirals (ARVs), to protect people who do not have the virus but who are at high risk of HIV infection.



Pre-exposure prophylaxis (PrEP):

The guidance is based on clinical trials indicating that a daily dose of oral antiretroviral medication, known as pre-exposure prophylaxis (PrEP), taken by HIV-negative people to reduce the risk of infection, is both safe for people to use and effective in preventing HIV. The iPrEX study shows that use of PrEP can reduce HIV infection by around 40% among men who have sex with men – and up to 73% among those who took the medicine regularly. The Partners PrEP study found 75% protection among serodiscordant couples (couples in which one person is HIV positive) in Kenya and Uganda.

The range of results in these studies highlight the potential benefits of PrEP, but also the importance of combining it with consistent use of condoms, as well as frequent HIV testing, counselling, and treatment of sexually transmitted infections.

They also emphasize the importance of taking medicines every day. Many people who are at high risk for HIV may not easily be able to incorporate the diligent treatment regimen required, so the next challenge is to ascertain how best to deliver PrEP to those who would benefit from it in ‘real life’ settings in order to achieve the necessary adherence and maximum public health gains.


PrEP projects in countries:

To better understand how PrEP can best contribute to a combination HIV prevention programme, WHO is encouraging countries wishing to introduce PrEP to first establish small projects to help public health workers to better understand and realize its potential benefits. In these projects, ARVs would be given to people at high risk of HIV infection. These could include uninfected men or transgender women who have sex with men who have a high risk of being HIV-positive. The aim is to identify which groups will benefit most from PrEP, and ascertain the best ways to deliver the services to them.

WHO will evaluate the outcome of these projects, together with the evolving scientific evidence. The results will help determine the best way to integrate PrEP guidance in future consolidated WHO guidelines on the use of antiretrovirals for preventing and treating HIV infection, which are expected in the summer of 2013.


Read the rest.



[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

11 July 2012

Investigating the Impact of Treatment on New HIV Infections

via PLoS Collections


Issue ImageThe HIV Modelling Consortium aims to strengthen the support that mathematical modelling and related quantitative disciplines can provide to global decision-making in HIV. In November 2011 the HIV Modelling Consortium held a meeting in South Africa to focus on the cross-cutting issues of the impact of new scientific findings about HIV treatment preventing new infections. The group considered the feasibility of interventions, potential epidemiological impact, affordability, and new scientific observational studies and community trials. The nine reviews and one research article which comprise this collection arose from that meeting and provide insights into the factors which will support evidence-based decision-making in HIV prevention, with a focus on the use of antiretroviral treatment to prevent HIV transmission.


Read the rest here.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

20 June 2012

WHO Updates Treatment-As-Prevention Plan for HIV and TB


“It is certain that TasP [Treatment as Prevention] needs to be considered as a key element of combination HIV prevention and as a major part of the solution to ending the HIV epidemic.”

With that statement, the World Health Organization (WHO) issued its June 2012 Programmatic Update on Antiretroviral Treatment as Prevention (TasP) of HIV and TB, available at the link below.

As countries continue to expand antiretroviral therapy (ART) programs for HIV-positive children and adults, WHO says, “it is expected that they will concurrently identify opportunities to maximize the use of ART for prevention purposes.”

TasP should focus on specific populations—such as HIV-discordant couples and pregnant women—in whom prevention should have the greatest impact. UNAIDS issued updates and guidance for these populations “and is working with countries to address programmatic and operational challenges to inform the consolidated guidelines to be released in mid-2013.”

The Programmatic Update includes guiding principles, the evidence base for TasP, a review of the current status of national HIV treatment guidelines and implementation experience with TasP, programmatic and operational considerations, and WHO’s three priority areas:

• Develop norms and standards for treatment as prevention
• Inform programmatic and operational decisions
• Define metrics for monitoring and evaluating the impact of TasP

WHO’s Gottfried Hirnschall told attendees at a London meeting that the new TasP recommendations will almost double the number of people judged to need antiretroviral therapy, aidsmap.com reports.

Read the rest.


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

18 June 2012

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.

Why Go Global?

Clinical trial data are often collected from varied populations to support a license application because geographically different trial sites are needed to ensure the product is safe and works in the same way in varying ethnic groups. This requirement is true whether it is a pharmaceutical company working on the next blockbuster drug or a non-for-profit partnership (which typically have a pharmaceutical partner involved in a non-for-profit capacity) developing a new drug or vaccine for a neglected disease. Here scientific and regulatory factors combine to encourage the globalisation of clinical trials.

Read the rest. 


[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position. Please look for us on Facebook here www.facebook.com/MappingPathways and you can follow us on Twitter @mappingpathways as well.]

08 May 2012

PEPFAR Program Outlines End of Year Progress to the Congress

via Science Speaks, by Meredith Mazzotta

PEPFAR releases 8th annual report to Congress: The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program delivered its 8th annual report to Congress recently. The five-page document outlines the program’s progress as of the end of fiscal year 2011 in various areas including:  supporting 3.9 million people on antiretroviral treatment; testing 9.8 million pregnant women for HIV in the course of the year; providing prevention of mother-to-child transmission services to more than 660,000 HIV-infected pregnant women allowing 200,000 babies to be born HIV-free; and providing care and support for nearly 13 million people, including more than 4.1 million orphans and vulnerable children. The report also stressed the importance of “leading with science” as we respond to the pandemic, smart investments including spurring private-sector engagement, country ownership, and shared responsibility.

TB institute confirms 8 patients resistant to all known TB drugs:  According to this article in the Hindustan Times, eight of the 12 patients originally reported as having what was coined “totally” or “extremely” drug resistant TB (neither term is recognized by the World Health Organization) have received confirmatory sputum sample testing that show resistance to all first- and second-line TB drugs. Since the original diagnoses of the dozen patients, three have died and, according to a city TB officer, of the six patients that remain in Mumbai, five are undergoing treatment for extensively drug-resistant TB, and one is being treated at Hinduja hospital.

Nonprofit TB Vaccine Developers Sign MOU to Accelerate Progress: Aeras announced it will be joining with the Tuberculosis Vaccine Initiative (TBVI) to “enhance and strengthen collaborative efforts to advance the world’s most promising TB vaccine candidates.” The memorandum of understanding between the two organizations will work to address opportunities and challenges in TB vaccine development that were outlined in the strategic blueprint released by advocates in late March, and published in the journal Tuberculosis, just before World TB Day. According to the Aeras press release, the two organizations will advise each other on vaccines in development, work to streamline the process of candidate selection and review, as they work together to achieve the goals outlined in the blueprint.

Read the Rest.


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

17 February 2012

World Health Organization Latest Statement on the Link Between Hormonal Contraceptives and HIV

via Plus News

Four months after a study suggested women on hormonal contraception may be at an increased HIV risk, the World Health Organization (WHO) has reaffirmed the birth control method's safety, but strongly recommends that women on progesterone-only injections, like Depo-Provera, also use condoms to prevent HIV infection.

In October 2011 the British medical journal, The Lancet, published the findings of a study showing that women who relied on hormonal shots to prevent pregnancy doubled their HIV risk. They also found that women on this type of birth control and living with HIV doubled the chances that they could transmit HIV to their partners.

Although the women in the study did not identify their birth control methods, most were probably using the progesterone-only, depot medroxprogeterone acetate shot. More commonly known by the brand name, Depo-Provera, this drug is the backbone of most African family-planning programmes.

The study prompted WHO meetings in late January and February 2012, during which experts and civil society representatives reviewed research on hormonal contraception and HIV risk. However, because no clinical trial has ever looked specifically at this potential link, including the October 2011 study, evidence remains largely inconclusive.

In the absence of a proven link between hormonal contraception and HIV infection, the WHO issued a statement on 16 February standing by current guidelines that allow women living with or at high risk of HIV to use hormonal contraception. However, the body has recommended that current guidelines be amended to advise women using progesterone-only injections be strongly advised to use condoms concurrently to prevent HIV infection. 

The need for future research into the matter was discussed at side meetings, said Dr Jared Baeten of the US University of Washington, one of the authors of the 2011 study. Although no decision was taken, he added that conducting such a trial would pose serious challenges. About 12 million women in sub-Saharan Africa are estimated to be on injectable contraception.

Read the Rest.


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

13 February 2012

WHO experts fail to agree on recommendations surrounding injectable contraceptives

via AllAfrica.com, by John Muchangi

Health experts have failed to agree on the use of injectable contraceptives, which were linked to increased HIV infections in Kenya. World Health Organisation said the decision will now be made when another team meets on February 15.

WHO had initially formed a team of 53 experts from 20 countries to review the research which revealed that injectable contraceptives like Depo Provera double the risk of contracting HIV.

Recommendations made by that team will now be assessed by the WHO Guidelines Review Committee - the body that oversees the production of WHO public health guidelines for countries. "The Committee will meet on 15 February and announce its recommendations the following day," said the organisation's spokeswoman Fadéla Chaib.

She insisted hormonal contraceptives and intrauterine devices known as IUDs do not offer any protection against HIV or other sexually transmitted infections. "Condoms are the mainstay of dual protection against both unwanted pregnancy and STIs including HIV," she said in a statement.

WHO's last guidance in 2009, based on the best evidence available at that time, said women at high risk of HIV infection and those living with HIV could safely use hormonal methods.

However, last year's study by the University of Washington, Kenyatta National Hospital, University of Nairobi and Moi University offered a different opinion. The study, published in The Lancet medical journal, revealed that injectables double the risk of women contracting HIV and also increase the risk of HIV-positive users infecting their male partners. It involved 3,800 couples from Kenya,Uganda, Tanzania, Botswana, Rwanda, South Africa and Zambia.

Read the rest.


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

11 January 2012

What it really takes to prevent mother-to-child HIV transmission


Background

The World Health Organization (WHO) has called for the “virtual elimination” of pediatric HIV: a mother-to-child HIV transmission (MTCT) risk of less than 5%. We investigated uptake of prevention of MTCT (PMTCT) services, infant feeding recommendations, and specific drug regimens necessary to achieve this goal in Zimbabwe.

Methods and Findings

We used a computer model to simulate a cohort of HIV-infected, pregnant/breastfeeding women (mean age, 24 y; mean CD4, 451/µl; breastfeeding duration, 12 mo). Three PMTCT regimens were evaluated: (1) single-dose nevirapine (sdNVP), (2) WHO 2010 guidelines' “Option A” (zidovudine in pregnancy, infant nevirapine throughout breastfeeding for women without advanced disease, lifelong combination antiretroviral therapy for women with advanced disease), and (3) WHO “Option B” (pregnancy/breastfeeding-limited combination antiretroviral drug regimens without advanced disease; lifelong antiretroviral therapy with advanced disease). We examined four levels of PMTCT uptake (proportion of pregnant women accessing and adhering to PMTCT services): reported rates in 2008 and 2009 (36% and 56%, respectively) and target goals in 2008 and 2009 (80% and 95%, respectively). The primary model outcome was MTCT risk at weaning.

The 2008 sdNVP-based National PMTCT Program led to a projected 12-mo MTCT risk of 20.3%. Improved uptake in 2009 reduced projected risk to 18.0%. If sdNVP were replaced by more effective regimens, with 2009 (56%) uptake, estimated MTCT risk would be 14.4% (Option A) or 13.4% (Option B). Even with 95% uptake of Option A or B, projected transmission risks (6.1%–7.7%) would exceed the WHO goal of less than 5%. Only if the lowest published transmission risks were used for each drug regimen, or breastfeeding duration were shortened, would MTCT risks at 95% uptake fall below 5%.

Conclusions

Implementation of the WHO PMTCT guidelines must be accompanied by efforts to improve access to PMTCT services, retain women in care, and support medication adherence throughout pregnancy and breastfeeding, to approach the “virtual elimination” of pediatric HIV in Zimbabwe.

Read the rest of the study here.


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

30 December 2011

Mapping Pathways 2011: The year in voices

Original content from the Mapping Pathways blog team

“We are on the verge of a significant breakthrough in the AIDS response. The vision of a world with zero new HIV infections, zero discrimination, and zero AIDS-related deaths has captured the imagination of diverse partners, stakeholders and people living with and affected by HIV. New HIV infections continue to fall and more people than ever are starting treatment. With research giving us solid evidence that antiretroviral therapy can prevent new HIV infections, it is encouraging that 6.6 million people are now receiving treatment in low- and middle-income countries: nearly half those eligible.” - Michel Sidibe, UNAIDS Executive Director, World AIDS Day report


Earlier this month, WHO and UNAIDS released a World AIDS Day report providing a snapshot of goals and progress made in 2011 toward HIV/AIDS prevention. We thought we’d provide a snapshot of the Mapping Pathways project as well – but through the voices of some of the most memorable and inspiring people we spoke with this year.

APRIL:
“It’s been like Christmas every day since July at the International AIDS Conference in Vienna when the CAPRISA study results came out… We’ve gotten over this first hurdle; we’ve proven that we can create new ways to prevent HIV through the use of ARVs taken orally or applied topically but now we have to figure out how to get that pill, or gel, or whatever into the right hands in the right place at the right time. We’re grappling with all the problems that come with success.” - Jim Pickett: ‘Success! Now what?’
   
MAY:
“There is a threat – still distant but definitely visible – that we will lose this astonishing success through complacency… We can make AIDS rare – and eliminate it entirely from rich countries – using technologies that we already have. The question is whether we have the will to do it.”  - Mark Chataway: Using antiretrovirals to prevent new infections

“There’s still so much we don’t know, and these are open questions rather than being settled questions… we can’t prove that the intervention worked, and we can’t prove that the intervention didn’t work … There are still things to be learned.”  - Julie Davids: FEM-PrEP closure update – What does ‘futility’ mean exactly?

“I think whenever the field starts to go on emotion, we get into trouble… Human behavior keeps messing up the plot.”  - Dr. Linda-Gail Bekker: Of Mice, men, and microbicide trials   

JUNE:
 “I put the word MSM on the board, and do you know what one woman participant said? She said, ‘By MSM do you mean men who have sex with men? Yes, they must die; and if not, they must be killed!’ I was so taken aback. I thought, ‘Oh my God, this is where the advocacy has to start from.’” - Brian Kanyemba: A snapshot of advocacy in Africa

“The level of efficacy seen in the HPTN052 study is stunning, and is extremely important on several fronts. First, in terms of the potential of this strategy to reduce transmission, it is clearly an effective option… Of course, there are some issues associated with this strategy as well.”  - Dr. Joe Romano: Thoughts on the microbicide pipeline and the recent HPTN 052 results

“I believe that it is a political, economic and human tragedy that the first time our country has had a national HIV/AIDS strategy is exactly at the same time that we’re being told there are no resources to put it fully into place... We are, in significant ways, being restrained from putting our best minds and hearts at the forefront of this effort. When we get to the end of the day, there are good ideas, and then there are good ideas that are fully funded.”  - Julie Davids: The economic effect of HIV/AIDS in the US

JULY:
“Sex sells. People in the commercial world use sex to sell things like cars, toothpaste, pens…almost anything! Why not use sex to sell safer sex?”  - Anne Philpott: How sexy sex can help prevent HIV transmission

“Working with vulnerable populations like transgender individuals and men who have sex with men (MSM) was really an eye opener. These are people who often have nothing to their name (often not even a roof over their head), are disowned by society and their families and are completely discriminated and stigmatized against. Yet a number of them were keen to help spread awareness about HIV/AIDS, prevention options and vaccines so that others may benefit from the information and not get infected with HIV. This degree of humanity is truly remarkable.”  - Dr. Sonali Kochhar: PrEP in India

AUGUST:
“My sense is that many people are still very uncomfortable and not quite able to figure out why we’re talking about PrEP in the Indian context. Many senior people in the field feel the focus needs to be on TLC+.”  - Anjali Gopalan: Notes from India – concerns and challenges around PrEP

“The matchmaking started because people living with HIV don’t disclose their status to their parents. In India, when the boy is 30 or the girl is 24-25, the parents want them to get married. They start looking for partners and the person who is infected is unable to talk freely to them and say, ‘Look, I have HIV and I can’t get married.’ That’s when they come to me and ask, ‘My parents are planning to get me married to an HIV-negative person – now what do I do?’ So we say okay, we’ll look for someone for you."  - Dr. Suniti Solomon: A modern-day HIV love story

“Clearly if people abstained from sex, or had sex with partners they knew to be uninfected, or used condoms 100% of the time, we wouldn’t have the HIV epidemic. But obviously, spreading billboards all over the world has not cut it.” - Dr. Linda-Gail Bekker: Safe-sex education – too little, too much?

“Placebo controlled trials are essential for the evaluation of the safety and efficacy of new products.  The placebo control group in a clinical trial provides the means of establishing any specific safety issues with a product, as well as the effectiveness of the product at preventing HIV transmission… Once a microbicide product has been adequately shown to prevent HIV transmission, it will no longer be possible to run placebo controlled trials, and the “window” will be closed."  - Dr. Joe Romano: What happens when the ‘placebo window’ closes?

SEPTEMBER:
“It boggles me that I still have to make the case for understanding the relational and contextual nature of HIV transmission and the need to recognize that people and technologies are interactive and interdependent."  - Judith Auerbach: Addressing social drivers of HIV/AIDS

“Even among groups of experts, I have noticed people getting confused – misapplying data, conclusions, or assumptions...”  -  Lori Heise: Tricky Terminology in HIV Prevention – Microbicides and Oral PrEP

“Giving gay men more information about their health only empowers them to make informed decisions. The fear that gay men will take PrEP, forego condoms and become out of control disease spreaders, harkens to the days when men feared women would become crazed nymphomaniacs thanks to the new birth control pill.” -Alex Garner: Open letter Urges that PrEP debate should be based on ‘facts not misinformation’

OCTOBER:
“Firstly, we need to work out whether this result is true or not. But even if it is true, it’s quite possible that we need to balance the benefits of avoiding an unwanted pregnancy against the small increased risk of acquiring HIV infection.”  - Dr. Tim Farley: Hormonal contraceptives and HIV – the grey area

“It’s really critical we know what research is and is not being done, what evidence does and does not exist, so that we have a solid understanding of the implications of these technologies in various social, economic, cultural, and political contexts that exist in different countries. It’s only then that we can begin to think about investing in them and the best ways to implement them."  - Molly Morgan Jones: Mapping Pathways so far – the ‘literature review’

NOVEMBER:
“If you’re talking about early treatment, you’ll have one person saying, ‘This is a quantum leap from where we are now, and it’s operationally impossible.’ And then you’ll have another person saying, ‘Well, if you have cancer, the doctor doesn’t wait till you’re half dead to give you the treatment, and so we should have been doing this years ago.’ And both are very valid points; it’s just how do you get those two people, who are equally important in making this happen, make it happen?” - Daniella Mark: It’s a question of ‘how’ in South Africa Part 1 & Part 2

DECEMBER:
“PrEP … is hard as hell to figure out. Hard as hell. But that’s what we have to do – we have to be right there, at the hardest place possible, trying to get the answers.” - Jim Pickett: Triumphs and Trials in 2011


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

09 December 2011

Successes of Second Line Treatment in Sub-Saharan Africa

via aidsmap, by Carole Leach-Lemens

Study Shows Malawi AIDS Deaths Drop 10 Percent"The authors conclude, “in ART programmes [in sub-Saharan Africa] switching patients to second-line regimens based on WHO immunological failure criteria appears to reduce mortality, with the greatest benefit in patients switching immediately after failure is diagnosed.”"

Mortality was reduced by about 75% among adults experiencing immunological failure according to the World Health Organization (WHO) criteria who switched to a second-line regimen compared to those who remained on a failing regimen in two public sector ART programmes without access to routine viral load monitoring in Zambia and Malawi, researchers report in the advance online edition of AIDS.

Additionally in this collaborative analysis Thomas Gsponer and colleagues on behalf of the Southern African region of the International epidemiological databases to evaluate AIDS (IeDEA-SA) showed the less time spent on a failing regimen the lower the risk of death, HR:0.70 (95%  credible intervals (CI): 0.44-1.09), p=0.11 for each six months of shorter exposure.

An estimated 6.6 million people are now getting ART in resource-poor settings. As access to treatment increases so does the number of people experiencing treatment failure with a corresponding increase in the use of second-line treatment regimens.

Cost and the absence of the necessary laboratory infrastructure preclude the regular use of viral load monitoring in resource-poor settings, especially in rural areas.

Without viral load monitoring immunological (CD4 cell counts) and clinical criteria are used to determine treatment failure. However, the accuracy of such criteria to detect virological failure is poor. This may lead to unnecessary switching with many health care providers reluctant to switch using these criteria. So people are switched later and at lower CD4 cell counts compared to programmes where viral load monitoring is available, note the authors.

The authors chose to examine further the effect of switching to second-line ART on mortality in settings without viral load monitoring.

All adult patients experiencing treatment failure according to WHO immunological criteria from two public sector ART programmes in Lusaka, Zambia and Lilongwe, Malawi were included in the analysis. Clinical and immunological monitoring was done every three to six months. In both sites viral load testing is limited because of cost and operational difficulties.

Criteria for inclusion: all patients 16 years of age and over with immunological failure after January 1, 2004 based on any of the three WHO criteria: 1) CD4 cell counts staying persistently under 100 cells/mm3 2) a fall of CD4 cell counts below the baseline count and 3) a fall greater than 50% from the peak value.

Read the rest.


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

27 October 2011

Hormonal Contraceptives and HIV Prevention: The grey area

 * Original content from our Mapping Pathways blog team

“The policy implications are very complicated, and we certainly don’t want to undermine the family planning programs merely because of results like this.”

Big news in the HIV prevention world is the possibility that women using injectible hormonal contraceptives might double their chances of acquiring and transmitting HIV infection. Read more about this preliminary finding, which was first presented at an HIV conference held in Rome this July, in a recent article published in the Lancet. While this issue is a current hot topic, it’s not a new one in the prevention community. In fact, Dr. Tim Farley remembers this issue being raised back in the 1980’s when AIDS had just been identified. Dr. Farley, a former scientist with WHO's Department of Reproductive Health and Research in Geneva, who has been specializing in the area of HIV prevention and the interaction between HIV and sexual and reproductive health for the past 20 years, helped us better understand what this finding could mean in the context of HIV prevention and health policy.

MP: How did you become involved in this area? Was there a particular project you worked on that lead you to this field?

TF: Well, soon after the HIV epidemic was identified, all the different departments at WHO were tasked by Jonathan Mann, who headed up the global program on AIDS, to consider what impact this newly identified viral infection would have on our work. And so we scratched our heads and thought about all the issues that could potentially impact our work, not only our work on maternal health and sexual health but also, more technically, our work on prevention. At that time, all we knew about prevention was that condoms worked, and so the idea of promoting condoms not only for pregnancy prevention but also for the prevention of this new sexually transmitted infection was a new one. So we convened in the late 1980’s to discuss all these issues and map out what was going to be important for our work over the next 10 to 20 years, and in fact, some of those issues that we listed then are still very hot and remain unanswered. For example, the interaction between hormonal contraception and HIV infection -- does it increase women’s susceptibility to infection, does it increase women’s infectiousness, does it modify the course of HIV disease in a beneficial or adverse way? These were questions that were listed in that first consultation, and just recently we had some new data presented in Rome related very much to this issue of increased susceptibility to HIV infection and increased risk of transmission from women to men.

MP: What was this data exactly?

TF: This was data presented by Renee Heffron from the University of Washington. It was actually a secondary re-analysis of data from an earlier HIV prevention randomized control trial that was published a few years ago called the Partners in Prevention. That trial, conducted in seven Sub-Saharan African countries, had been looking at acyclovir to see whether the drug reduces the risk of transmitting or acquiring HIV infection associated with herpes simplex infection. The new data presented by Heffron was a reanalysis of this data, but concentrating on the issue of whether users of hormonal contraception were more likely to acquire infection than women using other contraceptive methods, and also whether women using hormonal contraception who were HIV positive were more likely to transmit to their HIV negative partner.

MP: Why is this an important issue to explore?

TF: Well, hormonal contraception is one of the most widely used reversible methods of contraception worldwide. And in the African region, injectible contraceptives and/or combined oral contraceptives are the backbone of the modern family planning programs. The data from this study, though very limited, do suggest a doubling of the risk of acquiring HIV infection for women users of an injectible hormonal contraceptive. Now whether this is a disaster or not, that needs to be considered very carefully in context. There are huge benefits, particularly in the African region, of avoiding an unwanted pregnancy, not only for the morbidity issues but also for mortality reasons. So one has to weigh very carefully any excess risk. Firstly, we need to work out whether this result is true or not. But even if it is true, it’s quite possible that we need to balance the benefits of avoiding an unwanted pregnancy against the small increased risk of acquiring HIV infection. A doubling of risk sounds quite dramatic, but in fact it’s the attributable risk, that is the difference in risk, which is really critical. And any women living in these generalized epidemic areas in Southern and Eastern Africa has to be taking very good care to reduce her risk of HIV infection—for example, by using condoms or by making sure her partner is regularly tested for HIV. So in the context of a good HIV prevention strategy for an individual woman, a small increased risk of HIV infection with DMPA (a popular hormonal contraceptive) may well be a risk worth taking when you consider the benefits of using a reliable hormonal contraceptive method. We desperately need more data to confirm whether this finding is true. But as I mentioned, even if it is true, the balancing of the risks and benefits of different contraceptive methods in the presence of the HIV epidemic is extremely complex. So the policy implications are very complicated, and we certainly don’t want to undermine the family planning programs merely because of results like this.

Dr. Tim Farley is an independent consultant in HIV and sexual and reproductive health and a former scientist with WHO's Department of Reproductive Health and Research in Geneva. WHO is convening a consultation in early February 2012 to review all the data and to try and understand the policy implications. But for now, WHO and the U.S. Agency for International Development are making no new contraceptive recommendations and the two groups have emphasized the study's limitations. To read more about the reactions to this data, click on the links below:

Research Linking Contraceptives to HIV Raises Policy Questions

http://www.pbs.org/newshour/rundown/2011/10/research-linking-contraceptives-to-hiv-raises-policy-questions.html

Hormonal Contraceptives and HIV Risk—Emerging Evidence in Context
www.guttmacher.org/media/.../hormonal-contraceptives-HIV.pdf

Hormonal Contraceptives May Raise HIV Risk For Men And Women
http://www.npr.org/blogs/health/2011/10/04/141043578/hormonal-contraceptives-may-raise-hiv-risk-for-men-and-women

Use of hormonal contraceptives and risk of HIV-1 transmission: a prospective cohort study
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(11)70247-X/fulltext


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

24 October 2011

Kenyan government grapples with counterfeit ARVs

via PlusNews Global

Kenya's government is scrambling to remove thousands of batches of counterfeit antiretrovirals (ARVs) from circulation after patients and health workers reported irregularities in the appearance and texture of a widely used drug.

In September, nurses working with the medical NGO, Médecins Sans Frontières - which runs HIV and tuberculosis clinics in the capital, Nairobi, and western Kenya - reported irregularities in the appearance of the antiretroviral Zidolam-N, a combination treatment containing the ARVs zidovudine, lamivudine and nevirapine.

The ARVs were found to be falsified versions of a World Health Organization (WHO)-certified generic drug purchased through a distributor endorsed by the Kenya Pharmacy and Poisons Board (KPPB), the country's drug regulatory authority.

According to the KPPB, one batch of the fake Zidolam-N, with the number E100766, is marked as manufactured in 2009 and set to expire in May 2013, while a second carries the batch number A9366 with manufacture and expiry dates of June 2009 and May 2012 respectively. The main irregularities included discolouration, mould and crumbliness; the packaging is also of varying quality and the text differs in font and colour from the genuine drug.

Read the rest.


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

05 October 2011

Research Linking Contraceptives to HIV Raises Policy Questions

via PBS Newshour, by Talea Miller

Photo by World Health OranizationA study showing injected hormonal birth control could make women more vulnerable to HIV is raising big questions about medical guidance in regions with high HIV rates.

Research conducted by the University of Washington in seven African countries found use of injected hormonal contraceptives doubled women's risk of contracting HIV and the chances of passing HIV to a partner.

Policymakers are moving cautiously in response to the findings, which were first released this summer at an HIV conference and published again this week by the Lancet. The World Health Organization has scheduled a January 2012 review of the research, but for now the organization and the U.S. Agency for International Development are making no new contraceptive recommendations and the two groups have emphasized the study's limitations.

In a statement released in August when the study first surfaced, USAID noted flaws in the study's design and called for a randomized, controlled version to flesh out the results. The agency also noted that while a few previous studies show a connection between hormonal contraception and HIV transmission, the majority of previous research found no association.

"USAID does not believe that a change in contraceptive policy or programming is appropriate or necessary at this time," the statement said, and a USAID spokesperson said Tuesday that finding still stands.
The WHO also took issue with the study's reliance on data based off observations in a written response to the Lancet publication.

Read the rest.



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

27 September 2011

New data backs early HIV treatment cost-effectiveness

via PlusNews

Modelling has demonstrated the benefits and now data has provided the proof as researchers in Haiti have found that earlier HIV treatment is cost-effective, reducing the risk of death by 75 percent among HIV patients for just US$6.25 more a month.

In 2009, researchers released the results of a then unpublished Haitian clinical trial. Conducted among 800 HIV patients, the study showed that those who received antiretrovirals (ARVs) when their immune systems were stronger - at higher CD4 counts of 200 to 350 - were less likely to die than their peers who waited until their CD4 counts fell to 200.

About five months later, the World Health Organization (WHO) issued new HIV treatment guidelines that advised countries to start HIV patients on treatment at a new higher CD4 count of 350 instead of 200.

Now those researchers have released the world's first and possibly only cost-effectiveness study on earlier HIV treatment tied to a randomized clinical trial. Published in the September 2011 edition of the medical journal, PLoS Medicine, the study is based on data from the original Haitian study that allowed researchers to calculate costs associated with the first three years of earlier treatment - including everything from drug and family caregiver costs to subsidies for patient transport to and from the clinic.

Bruce Schackman, associate professor of public health at the US Weill Cornell Medical College and a co-author of the study, said this was probably the first and last research of its kind. Given the overwhelming evidence for early treatment, duplicating the study now would be unethical, he said.

Read the rest.


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

13 September 2011

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


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.

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

24 July 2011

Treatment As Prevention: We Urgently Need Policy Guidance

Via PLoS, by Nathan Ford.

The International AIDS Society conference on HIV Pathogenesis, Treatment and Prevention in Rome has been hailed as a landmark conference for HIV prevention. Just as the AIDS conference in Vancouver in 1996 marked the beginning of the international effort to roll out antiretroviral therapy globally, so Rome will likely be remembered as the beginning of a new era in biomedical prevention.

The results of the HTPN 052 discordant couples trial, which found the greatest incidence reduction of any prevention intervention evaluated to date, were met with a standing ovation. This trial found a 96% reduction in HIV transmission and a 40% reduction in serious complications, in particular tuberculosis (TB), among patients starting ART early, at CD4 350-550 cells/mm3.

Implementation of this strategy is, however, hampered by lack of guidance from the World Health Organization. Draft guidelines for the provision of ART in discordant couples have been in process for many months, and their release was first announced in May, and then again July. However, by the end of the conference it remained unclear when the guidelines would be released, or what they would say.
Rumours spread in the conference corridors that WHO had been pressured to delay the release. Some suggested the issue at stake was to find the right balance in investment between the results of HTPN 052 and those of the recently completed pre-exposure prophylaxis trials that also reported a substantial prevention benefit.

There are at least three reasons why such a trade off is wrong.

First, providing ART earlier is desirable for more reasons than reduced HIV transmission: the HIV-positive individual receives treatment at a stage in their disease that developed country guidelines already consider therapeutically beneficial; their risk of developing incident diseases, in particular TB, is substantially reduced; reducing TB incidences confers the additional public health benefit of reducing the risk of TB transmission.

Second, discussions about whether to give ART to HIV-positive or HIV-negative individuals are ethically problematic. Economics has long been described as the ‘dismal science’, but it is hard to think of a more dismal economic proposition than to delay giving ART to people already infected with the pathogenic HIV virus in order to give the drugs to HIV-negative individuals instead.

Third, there are fundamental practical differences to the two approaches. Implementing the results of HTPN 052 means further extending what is already happening (giving ART to HIV-infected individuals); in contrast, giving ART to HIV-negative, at-risk individuals requires extensive operational research to help define what is essentially an entirely new programmatic approach.

Read the rest here.

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