Three-quarters of clinicians in the US willing to prescribe early HIV treatment for the purpose of prevention

via aidsmap.com, by Michael Carter

There is an overwhelming consensus among clinicians who prescribe HIV treatment in the US that people who are taking antiretroviral therapy are less likely to transmit HIV to their sexual partners, according to results of a study published in the online edition of the Journal of Acquired Immune Deficiency Syndromes. Results also showed that over three-quarters of care providers would be willing to prescribe early therapy to people with an HIV-negative partner for the purposes of prevention.

The study involved 165 prescribing clinicians working at HIV clinics in the Bronx, New York, and Washington DC. It was conducted in 2010 and 2011, well before the publication of the results of the HPTN 052 study in the summer of 2012, which showed that virologically suppressive HIV treatment reduced the risk of transmission by 96%. US HIV treatment guidelines were updated in 2012 to endorse early treatment to reduce the risk of transmission.

“This survey of HIV clinicians in two US cities found most clinicians believe that ART [antiretroviral therapy] can reduce HIV transmission, even before the results of HPTN 052 demonstrated ART to be effective for this purpose, and before 2012 treatment guideline changes recommending ART for patients at risk for HIV transmission,” write the authors.

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.]

Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial

via The Lancet, by Lara Fairall et al.

Background

Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care.

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.]

An AIDS-Free Generation?

via Science, by Salim S. Abdool Karim

The HIV pandemic remains a great global health challenge.  With an estimated 3.3 million people living with HIV today, is there really hope of achieving the vision of an AIDS-free generation? Optimists argue that strong political will and generous funding are the essential elements. But skeptics point to the deep-seated structural inadequacies in many health care systems, especially in Africa, where the need is greatest.

However, both sides agree that a potential combination of therapeutic and prophylactic antiretroviral strategies brings the prospect of HIV control within reach. And this month, the International AIDS Conference in Washington, DC, “Turning the Tide Together,” will attempt to galvanize concerted global action to focus the world’s attention on this challenge.

Knowledge of HIV status is the common gateway to both treatment and prevention. But many people remain unaware of their HIV status. Denial, stigma, and a lack of understanding of vulnerability and risk lead to low rates of HIV testing, suboptimal condom use, and poor rates of circumcision. In addition to wider HIV testing, scale-up of ART therapy, both for the patient’s benefit and for the prevention benefi t to partners,will be key to reducing HIV transmission and to reaching zero new HIV infections.

Read the rest.

(This article requires you to sign up for a free registration to access to the full text)


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

via iasociety.org, by Mark Mascolini

“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.]

Patients in South Africa Increase the Use of Antiretroviral Treatment

via aidsmap.com, by Carole Leach-Lemens

South Africa exceeded national targets for new patients starting antiretroviral treatment (ART) by around 50% between 2007 and 2011 – achieving treatment coverage of close to 80% of eligible adults – according to new research carried out by Dr Leigh F Johnson, actuarial scientist at the University of Cape Town, published  in the March issue of The Southern African Journal of Medicine.

From mid-2004 to mid-2011, the total numbers of people receiving ART increased from 47,500 (95% CI: 42,900 to 51,800) to 1.79 million people (95% CI: 1.65 to 1.93 million). The latter figure represents close to 80% of adult treatment coverage, according to eligibility criteria in use during this period (CD4 cell counts under 200 cells/mm3). Using current South African CD4 cell count eligibility criteria (under 350 cells/mm3), coverage achieved decreases to 52% (95% CI: 46-57%).

While the targets were still exceeded, children and men started ART at considerably lower ratios than women.

Women accounted for 61%, men 31% and children 8% of the total.
Effective HIV treatment significantly reduces illness and death resulting from HIV, as well as onward transmission of HIV. Evaluating the effectiveness of HIV treatment and prevention programmes requires monitoring access to ART.

Previous monitoring assessments have shown a dramatic increase in access to ART in South Africa. While these assessments have suggested South Africa was on track to meet the targets of its HIV & AIDS & STI National Strategic Plan 2007-2011 (the NSP), no formal assessment has been made, Dr Johnson adds.


Read the Rest.


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

India's Involvement to the Change of HIV/AIDS

via the Hindustan Times, by Sanchita Sharma

A decade ago, New Delhi’s The Ashok turned away a dozen gay men who wanted to book a conference room at the hotel for a think-in on AIDS, which was still labelled a gay man’s disease. It took several phone calls from the senior bureaucracy at the Union Health Ministry’s National AIDS Control
Organisation (NACO) to get them a 12x12 conference room for one day.

“Five years ago, the same group of men who have sex with men (MSMs, the politically correct term for homosexuals) organised a huge convention at The Ashok, with 700 MSM and transgender participants overrunning the hotel for days. Laws may not have changed in the courts or in the books, but the law in the streets has changed, and this amazing turnaround in society’s attitude has happened because of AIDS,” says JVR Prasada Rao, former Union health secretary and National AIDS Control Organisation (NACO) chief, who was appointed the UN Special Envoy for AIDS in the Asia Pacific region this week.

Safe and sound, legally

 Change in social attitude is fantastic, no doubt, but it is not enough to keep new infection down. Legal environment around people most at risk — homosexuals, injecting drug users and sex workers — has to change to encourage them to seek HIV-prevention and treatment services that have been proven to cut down new infections dramatically, not just in India but everywhere around the world.

Last year, the HPTN052 study — HIV Prevention Trials Network’s study that was declared the Breakthrough of the Year 2011 by the journal Science — showed that if an HIV-positive person adheres to antiretroviral therapy (ART) used to treat AIDS, the risk of transmitting the virus to their uninfected sexual partner is reduced by 96%.

In March this year, the Africa Centre for Health and Population Studies reconfirmed the HPTN findings by presenting data showing that in areas where ART uptake is high (greater than 30%) people who do not have HIV are 38% less likely to get infected with the virus as compared to areas of low uptake (less than 10%).

With 7.4 million on HIV treatment globally, new HIV infections have fallen in 33 countries since 2001, though mostly in Africa and Asia. UNAIDS credits the halving of India HIV-infected people to 2.39 million to both improved data collection methods and an actual fall in new infections because NACO provides 4.48 lakh people free anti-retroviral therapy (ART), which lowers the HIV load in the body and lowers the risk of infecting partners while helping the infected live healthier and longer.

Read the Rest.


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

Evidence-Based Recommendations Presented on ART Adherence and Care

via Annals of Internal Medicine, by Melanie A. Thompson, MD

Description: After HIV diagnosis, timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy (ART). ART adherence is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance. The International Association of Physicians in AIDS Care convened a panel to develop evidence-based recommendations to optimize entry into and retention in care and ART adherence for people with HIV.

Methods: A systematic literature search was conducted to produce an evidence base restricted to randomized, controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point. A total of 325 studies met the criteria. Two reviewers independently extracted and coded data from each study using a standardized data extraction form. Panel members drafted recommendations based on the body of evidence for each method or intervention and then graded the overall quality of the body of evidence and the strength for each recommendation.

Recommendations: Recommendations are provided for monitoring of entry into and retention in care, interventions to improve entry and retention, and monitoring of and interventions to improve ART adherence. Recommendations cover ART strategies, adherence tools, education and counseling, and health system and service delivery interventions. In addition, they cover specific issues pertaining to pregnant women, incarcerated individuals, homeless and marginally housed individuals, and children and adolescents, as well as substance use and mental health disorders. Recommendations for future research in all areas are also provided.

The availability of potent antiretroviral therapy (ART) has resulted in remarkable decreases in HIV-related morbidity and mortality in the past 15 years (1, 2). Entry into and retention in HIV medical care is critical to the provision of ART, and adherence to ART is among the key determinants of HIV treatment success (3–6). More than 2 decades of targeted research in these areas has produced a varied and complex evidence base that, to date, has not been fully evaluated or distilled into concrete recommendations for how to best monitor or support HIV care and ART adherence.

Recent data from the U.S. Centers for Disease Control and Prevention reveal that only 28% of persons with HIV in the United States have achieved viral suppression while receiving ART (7). Of those who knew they had HIV, only 69% were linked to care, and only 59% were retained in care (8). These figures and comparable global data (9, 10) challenge us to explore best practices for improving entry into and retention in care on a global scale. Only with successful care linkage and retention can ART be accessed. Once patients are in care and are receiving treatment, high levels of adherence are required to prevent the selection of resistance mutations and subsequent virologic failure (11). In a global pooled sample of 33 199 adults taking ART in over 84 observational studies, only 62% of persons achieved adherence of at least 90% of doses (12). These data underscore the need for concise and clear evidence-based recommendations to help care providers monitor and support ART adherence.

Read the Rest.


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

The Impact 'Treatment as Prevention' has on HIV Incidence in Africa

via AidsMap.com, by gus Cairns

A longitudinal study from KwaZulu Natal province in South Africa is the first study from the global south to relate an increase in the proportion of adults on HIV treatment to a fall in HIV incidence, the 19th Conference on Retroviruses and Opportunistic Infections was told last week.

The study found evidence of a threshold effect; incidence started to fall once the proportion of all adults diagnosed with HIV in the area who were on treatment exceeded 30%.

Meanwhile, a study that took place in a week-long intensive health campaign in Uganda, as well as studies from areas as diverse as San Francisco and Swaziland, documented large increases in the proportion of people with HIV who are on treatment.

Falls in incidence in KwaZulu Natal

National surveys in South Africa have found evidence of significant falls in HIV incidence in recent years, but have related this to behavioural change rather than treatment. In the study presented at CROI, of a rural area of northern KwaZulu Natal centred on the mining town of Somkhele (Tanser), the researchers found a relationship between HIV treatment and a fall in infections.

They made use of a population-based HIV surveillance survey that has sampled 10,000 adults a year from 2004 onwards, by identifying 16,558 people who had taken at least two HIV tests during this period in order to gauge incidence rates. They then compared these data to individually linked data from the district-based HIV treatment and care programme.

Adult HIV prevalence in the area is high – 24%. The rate of new infections peaks at 8% a year in women in their early 20s and 5% a year in men in their late 20s. HIV testing rates are also high; researchers estimate that only 30% of the HIV-positive population is undiagnosed, a low proportion for Africa, and 75% of HIV-negative adults who have tested for HIV have done so more than once.

Since 2004, there has been a huge scale-up of HIV treatment, with 20,000 patients starting antiretroviral therapy since then, and by 2001 more than 40% of all adults diagnosed with HIV were on antiretroviral therapy (ART), and over 60% with a baseline CD4 count below 350 cells/mm3. HIV treatment at this CD4 threshold was only introduced in August 2011; previous to this it was 200 cells/mm3.

HIV incidence between 2004 and 2011 averaged 2.64% a year but was lower after 2009, when for the first time more than 30% of the diagnosed population was on ART. It was 3.0 to 3.5% 2007-09 but fell to 2.5% in 2010 and 2.0% in 2011.

After adjusting for HIV prevalence in the immediate area and demographic and behavioural variations, the researchers found that for every 10% increase in the proportion of adults on ART, the HIV incidence rate fell by 17%. Incidence was 40% lower when over 30% of the adult population was treated than when fewer than10% were. 

Read the Rest.


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

British HIV Association: Revised Guidelines for Antiretroviral Therapy

viaHivandHepatitis.com, by Liz Highleyman 

The British HIV Association (BHIVA) has issued revised guidelines for antiretroviral therapy (ART) for adults and for pregnant women and prevention of mother-to-child HIV prevention. Comments are currently being accepted.

ART for Adults

 

The draft for adults includes guidance on starting ART in treatment-naive patients, supporting people on treatment, and managing people who experience virological failure. The guidelines also cover special considerations for specific patient populations.

The guidelines are available on the BHIVA website, which features an online form for comments, and published in the January 2012 issue of HIV Medicine. The deadline for feedback is March 5, 2012.

As described in an overview by Aidsmap, the revised guidelines recommend that clinicians should discuss with all HIV positive patients the growing evidence that effective ART reduces the likelihood of HIV transmission to sexual partners. However, evidence to date -- for example, recent findings from study HPTN 052 showing a 96% risk reduction -- mainly concerns heterosexual couples having vaginal sex.

Patients should be informed of the prevention benefits of ART even if they do not yet need treatment for their own health because their CD4 T-cell count has not fallen below 350 cells/mm^3.

Unlike the latest U.S. guidelines -- which raised the treatment initiation level to 500 cells/mm^3 -- BHIVA kept the 350 cells/mm3 threshold for most patients, though people with certain coinfections and other risk factors (e.g., hepatitis B or C, HIV-related kidney disease or neurocognitive impairment) may benefit from starting sooner.

BHIVA came down in favor of tenofovir/emtricitabine (the drugs in the Truvada combination pill) as the favored dual nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) component of ART. U.S. guidelines also deem tenofovir/emtricitabine as the "preferred" NRTI combo, although the new European AIDS Clinical Society (EACS) guidelines rank tenofovir/emtricitabine and abacavir/lamivudine (the drugs in Epzicom) as equals.

BHIVA and the U.S. panel both demoted abacavir due to concerns about lower effectiveness for people with high viral load and elevated cardiovascular risk; tenofovir, however, has been linked to kidney impairment. All guidelines authorities agree that individual risk factors should be taken into account when selecting antiretroviral drugs.

BHIVA lists drugs in 3 classes as preferred third agents: the NNRTI efavirenz (Sustiva), the boosted protease inhibitors atazanavir (Reyataz) or darunavir (Prezista), and the integrase inhibitor raltegravir (Isentress).

Read the Rest.

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

Poor adherence usually cause of second-line treatment failure in resource-poor settings

via Aidsmap, by Carole Leach-Lemens

Poor adherence rather than drug resistance appears more likely to be the cause of virological failure among patients on second-line ART in resource-poor settings, according to a systematic review and meta-analysis published in the advance online edition of AIDS.

The cumulative pooled proportion of the 2035 adults comprising the 19 studies from eight countries in sub-Saharan Africa and Asia failing virologically was 21.8%, 23.1%, 26.7% and 38.0% at six, 12, 24 and 36 months, respectively.

The authors note caution should be taken when reviewing these estimates as there were considerable differences between the studies as well as substantial statistical differences.

While most of the studies did not provide enough information to be able to distinguish conclusively between poor adherence and drug resistance as reasons for virological failure, in those that did poor adherence was the primary cause.

Nonetheless these findings highlight the limited options available after second line in resource-poor settings, notably where drug resistance is the cause of virological failure.

The researchers also stress the importance of improved access to greater virological monitoring as well as more intensive adherence counselling before resistance mutations develop.

The scale-up of ART in resource-poor settings has had a considerable effect on reducing death and disease. Standardised regimens notably simple, affordable fixed-dose combination therapies have facilitated adherence with rates comparable to those in resource-rich settings.

Read the rest.


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

Cotrimoxazole cost-effective and lifesaving for people starting ART in Sub-Saharan Africa

via Aidsmap, by Carole Leach-Lemens

Achieving full coverage of cotrimoxazole prophylaxis during the first six months of antiretroviral therapy would be a highly cost-effective way of reducing early death among those with advanced HIV infection in sub-Saharan Africa, researchers report in the advance online edition of the Journal of Acquired Immune Deficiency Syndromes.

The researchers developed a decision-analytic model from a health care perspective to compare costs and outcomes. Full cotrimoxazole prophylaxis coverage at an estimated additional cost of $3.29 for each person on ART prevented an additional 22 deaths compared to the base-case scenario (from 94 to 72 deaths per 1000 patients) at a cost of $146.91 for each death prevented over the first six months.

Potential cost savings for specific opportunistic infections (OIs) prevented by cotrimoxazole prophylaxis were also calculated.

Prevention of 45 new malaria episodes per 1000 persons treated would save between $69.95 and $203.32 per case averted, while prevention of 22 severe bacterial infections per 1000 persons would save between $68.62 and $126.71 per case averted. Prevention of four new cases of pneumocystis pneumonia would save between $75.69 and $88.41per case averted.

An intervention is considered very cost-effective by the World Health Organization if the incremental cost per life-year saved is no greater than the GDP per capita; in the case of the poorest countries in Africa this was calculated at $1695 in 2005. This analysis is not strictly comparable because it calculates cost savings in deaths averted.

Over the past decade the increasing availability and access to ART in resource-poor settings has resulted in reductions in AIDS-related deaths.

Yet, in sub-Saharan Africa people continue to present for care at an advanced stage of illness resulting in high rates (8-20%) of early death after starting ART compared to North America and Europe. Common causes of death include tuberculosis, pneumonia and diarrhoeal illnesses.

In North America and Europe it is common practice to give cotrimoxazole prophylaxis to those who present for care with advanced HIV, primarily to prevent PCP. Its use in African settings, however, appears to protect against a wider range of infections and is not restricted to those with advanced HIV.

Recent studies in sub-Saharan Africa, while not randomised, have shown a consistent reduction in death where people on ART got cotrimoxazole compared to no cotrimoxazole, note the authors. In particular cotrimoxazole has been shown to reduce the risk of tuberculosis and of malaria in people taking antiretroviral therapy. A meta-analysis of seven studies shows that cotrimoxazole prophylaxis reduced the death rate in people taking antiretroviral therapy by almost 60%.

Read the rest.


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

Measuring condom usage and ART coverage in South Africa

via Journal of the Royal Society, by Leigh F. Johnson, Timothy B. Hallett, Thomas M. Rehle, and Rob E. Dorrington

This study aims to assess trends in human immunodeficiency virus (HIV) incidence in South Africa, and to assess the extent to which prevention and treatment programmes have reduced HIV incidence. Two models of the South African HIV epidemic, the STI (sexually transmitted infection)–HIV Interaction model and the ASSA2003 AIDS and Demographic model, were adapted. Both models were fitted to age-specific HIV prevalence data from antenatal clinic surveys and household surveys, using a Bayesian approach. Both models suggest that HIV incidence in 15–49 year olds declined significantly between the start of 2000 and the start of 2008: by 27 per cent (95% CI: 21–32%) in the STI–HIV model and by 31 per cent (95% CI: 23–39%) in the ASSA2003 model, when expressed as a percentage of incidence rates in 2000. By 2008, the percentage reduction in incidence owing to increased condom use was 37 per cent (95% CI: 34–41%) in the STI–HIV model and 23 per cent (95% CI: 14–34%) in the ASSA2003 model. Both models also estimated a small reduction in incidence owing to antiretroviral treatment by 2008. Increased condom use therefore appears to be the most significant factor explaining the recent South African HIV incidence decline.

Read the full article here.


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

Viral load's effect on ARV therapy

via aidsmap, by Michael Carter

Suppressing viral load to below 50 copies/ml may not be enough to ensure the long-term success of antiretroviral therapy, according to a UK study published in the March edition of Clinical Infectious Diseases.

Using ultra-sensitive viral load assays, investigators at the Royal Free Hospital, London, found that patients with a viral load between 40-49 copies/ml were significantly more likely to experience a rebound in viral load above 50 copies/ml and 400 copies/ml when compared to individuals with viral load between 39 and 3 to 10 copies/ml and patients with a truly undetectable viral load.

The investigators recommend “treatment efficacy should be reviewed” for patients whose viral load is above the very lowest levels.

However, the authors of an editorial accompanying the study are less convinced about the significance of its findings.

The goal of modern HIV therapy is a viral load below 50 copies/ml. Studies have shown that a sustained increase above this level is associated with the virological failure of therapy and the emergence of drug-resistant strains of HIV.

Assays capable of accurately measuring viral load to 40 copies/ml have been developed. In approximately two-thirds of cases, the assays can also detect viral load to a threshold of 10 copies/ml.
Viral load at an ultra-low level – between 3 to 10 copies/ml – is often labelled “residual viraemia” and cannot be eradicated with treatment intensification.

Read the rest.


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

Measuring quality of life concerns for people living with HIV

via Aidsmap, by Michael Carter

Fears about transmitting HIV to others, worries about the future, self-esteem problems, difficulty sleeping and treatment issues are now important quality of life concerns for people living with HIV that are not measured by existing resources, according to a report on a new quality of life measurement tool published in the online edition of the Journal of Acquired Immune Deficiency Syndromes.

The tool – called PROQOL-HIV (Patient Report Outcomes Quality of Life – HIV) - was developed with the participation of 152 HIV-positive patients in nine countries on five continents.

“PROQOL-HIV is a novel multidimensional HIV-specific HRQL [health-related quality of life] instrument that strives to be sensitive to socio-cultural context, disease stage and treatment in the HAART [highly active antiretroviral therapy] era,” write the authors. “Important new HRQL issues were uncovered from the culturally diverse experiences of PLWHA [people living with HIV/AIDS] in previously under-represented populations.”

Effective antiretroviral therapy has transformed the prognosis of many HIV-positive patients. However, people living with HIV still experience considerable changes in their health-related quality of life. Tools to measure such outcomes were developed in the era before potent HIV treatment became available. Moreover, they did not take account of the geographic, ethnic and cultural diversity of the epidemic.

Therefore an international team of investigators set out to develop a new instrument that was sensitive to the impact of HIV therapy, different diseases stages and applicable across settings. It derived from in-depth interviews conducted with patients living with HIV in 2007 and 2008. The patients were recruited in high-, middle- and low-income countries.
The interviews identified eleven broad areas of concern.

Read the rest.


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

PMTCT Requires Greater Male Participation in Ethiopia

via PlusNews Global

Ethiopia's new plan to eliminate mother-to-child HIV transmission by 2015 cannot be attained unless men are more meaningfully involved in reproductive health, experts say.

"Among the pregnant women who come to our hospital, less than 10 percent of them come with their partners," said Etalem Gebrehiwot, head nurse at the prevention of mother-to-child transmission (PMTCT) wing of Gandhi Memorial Hospital. "Those who find out that they are living with the virus usually face a problem while taking medicines, given that most prefer to take it without the knowledge of their partners."

Studies show that low male partner involvement is one of the challenges to the success of the country's PMTCT programme.

According to experts, men's involvement in PMTCT can have a positive impact on PMTCT by encouraging their partners to visit antenatal clinics and have skilled health workers attend the birth of their children. In a 2010 Kenyan study, male partner involvement in PMTCT reduced the risks of vertical transmission and infant mortality by more than 40 percent compared to no involvement.

"The biggest challenge we are currently facing is to convince mothers to get tested in order to determine that they are eligible for PMTCT services... the major reason for their resistance is lack of consent from their husbands or partners, who are more influential in family matters including this," said Aster Shewa, who supervises Zewditu Hospital antiretroviral service centre in Addis Ababa.

"Besides, after they know their status, most HIV-positive mothers refrain from disclosing it, which usually impacts the way they use PMTCT services and their effectiveness," she added.

Many men do not see the advantages of an HIV test; one father, whose wife gave birth to a daughter in November 2011, told IRIN/PlusNews: "We are married - what is there to test about?"

"At the moment, hospitals with PMTCT services are increasing, and we have to work hard in convincing pregnant women, along with their partners, to use health facilities with the service in order to reach zero new infections," said Aster.

Read the rest.


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

Successes of Second Line Treatment in Sub-Saharan Africa

via aidsmap, by Carole Leach-Lemens

"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.]

The Beginning of the End of AIDS

via The Huffington Post, by Sheila Nix

Everyone loves a good "they said it couldn't be done" story. From a man on the moon to a personal computer in every home, the nostalgic in each of us loves to reflect about how, throughout history, individuals have run up against the status quo, defied the odds, and achieved something inspirational for society at-large. Those of us in the AIDS advocacy community have experienced our fair share of doubters telling us "it can't be done."

30 years ago when HIV/AIDS cases were first documented, it was a mysterious infection that couldn't be treated. Positive diagnosis was a death sentence. With no treatment, stigma and fear grew, representing what Dr. Anthony Fauci calls "the dark years." But with scientific innovation came the discovery in 1987 of AZT, the first drug approved to treat HIV. Over the next few years, AZT was replaced with more sophisticated combination drug therapy, and by 1996 highly active antiretroviral therapy had been developed. The new drugs were hugely expensive, however, costing $10,000 per year or more. Many HIV-positive people feared that without Magic Johnson's checkbook, they wouldn't be able to get the drugs they needed to keep them alive. Today, AIDS treatment costs just a few hundred dollars per year in poor countries -- a victory for HIV-positive communities around the world.

In the early 2000s, as President Bush and bipartisan Congressional leaders were launching a program called PEPFAR and as the Global Fund to Fight AIDS, Tuberculosis, and Malaria was just getting started, the doubters loomed large. Many believed there was no way to get antiretroviral treatment to millions -- particularly in Africa where some infamously suggested "Africans don't have watches" and so couldn't be expected to take drugs in a consistent manner. Others argued that mobilizing the financing required to hit PEPFAR and Global Fund targets was impossible. Yet global funding for AIDS skyrocketed, growing six-fold between 2002 and 2008. African leaders also stepped up, committing to spend 15% of their budgets on health. Today, the results speak for themselves: 6.6 million HIV-positive people, including those in remote communities, are alive today because of treatment, and countless others have remained HIV-negative thanks to prevention efforts.

In spite of these achievements, economic recessions have a unique way of allowing the "it can't be done" mantra to reemerge. Indeed, as budgets constrict and leaders turn their attention inward, it's easy to see why a renewed push on global AIDS doesn't seem possible. Yet 2011 marks a critical inflection point in our fight against AIDS. Game-changing studies have offered exciting new tools in the fight to prevent HIV -- including new data that shows treatment works as prevention, reducing the likelihood of passing on HIV by as much as 96%. Collectively, these advances show that bending the curve on AIDS is possible in our generation.

Read the rest.

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

Integrating ART in Patients with TB

via The New England Journal of Medicine, by Salim S. Abdool Karim, M.B., Ch.B., Ph.D., Kogieleum Naidoo, M.B., Ch.B., Anneke Grobler, M.Sc., Nesri Padayatchi, M.B., Ch.B., Cheryl Baxter, M.Sc., Andrew L. Gray, M.Sc.(Pharm.), Tanuja Gengiah, M.Clin.Pharm., M.S.(Epi.), Santhanalakshmi Gengiah, M.A.(Res.Psych.), Anushka Naidoo, M.Med.Sci.(Pharm.), Niraksha Jithoo, M.B., Ch.B., Gonasagrie Nair, M.B., Ch.B., M.P.H., Wafaa M. El-Sadr, M.D., M.P.H., Gerald Friedland, M.D., and Quarraisha Abdool Karim, Ph.D.

Background

We previously reported that integrating antiretroviral therapy (ART) with tuberculosis treatment reduces mortality. However, the timing for the initiation of ART during tuberculosis treatment remains unresolved.

Methods

We conducted a three-group, open-label, randomized, controlled trial in South Africa involving 642 ambulatory patients, all with tuberculosis (confirmed by a positive sputum smear for acid-fast bacilli), human immunodeficiency virus infection, and a CD4+ T-cell count of less than 500 per cubic millimeter. Findings in the earlier-ART group (ART initiated within 4 weeks after the start of tuberculosis treatment, 214 patients) and later-ART group (ART initiated during the first 4 weeks of the continuation phase of tuberculosis treatment, 215 patients) are presented here.

Results

At baseline, the median CD4+ T-cell count was 150 per cubic millimeter, and the median viral load was 161,000 copies per milliliter, with no significant differences between the two groups. The incidence rate of the acquired immunodeficiency syndrome (AIDS) or death was 6.9 cases per 100 person-years in the earlier-ART group (18 cases) as compared with 7.8 per 100 person-years in the later-ART group (19 cases) (incidence-rate ratio, 0.89; 95% confidence interval [CI], 0.44 to 1.79; P=0.73). However, among patients with CD4+ T-cell counts of less than 50 per cubic millimeter, the incidence rates of AIDS or death were 8.5 and 26.3 cases per 100 person-years, respectively (incidence-rate ratio, 0.32; 95% CI, 0.07 to 1.13; P=0.06). The incidence rates of the immune reconstitution inflammatory syndrome (IRIS) were 20.1 and 7.7 cases per 100 person-years, respectively (incidence-rate ratio, 2.62; 95% CI, 1.48 to 4.82; P<0.001). Adverse events requiring a switching of antiretroviral drugs occurred in 10 patients in the earlier-ART group and 1 patient in the later-ART group (P=0.006).

Conclusions

Early initiation of ART in patients with CD4+ T-cell counts of less than 50 per cubic millimeter increased AIDS-free survival. Deferral of the initiation of ART to the first 4 weeks of the continuation phase of tuberculosis therapy in those with higher CD4+ T-cell counts reduced the risks of IRIS and other adverse events related to ART without increasing the risk of AIDS or death. (Funded by the U.S. President's Emergency Plan for AIDS Relief and others; SAPIT ClinicalTrials.gov number, NCT00398996.)

Read the rest.


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

From Tuskegee to Transparency: An Evolution in the Ethics and Accountability of Clinical Trials Involving Human Subjects

via RH Reality Check, by Anna Forbes and Kate Ryan

People who participate in clinical trials take the enormous step of volunteering to test a product that may be useful and, sometimes, life-saving if it turns out to be effective. They play an irreplaceable role in research to prevent, treat, and sometimes cure illness – as well as to find other ways to improve people’s health and lives.

Trial participants make a profoundly personal contribution and accept potential medical, social, and personal risks on behalf of others. An ethical trial is one that eliminates or minimizes participants’ risks as much as possible, invests in making sure that participants understand clearly what they are volunteering for, and protects their rights at every step.

For example, without clinical trials, we would not have seen recent advances in antiretroviral drugs to treat HIV, long-acting contraceptive choices that allow women greater control over their use, or microbicides that may be able to protect women from HIV.

The United States government has rules to protect people who participate in federally-funded biomedical and behavioral research. The rules vary depending on which agency is supporting the research, but they all share a starting point known as the Common Rule, a set of regulations for all federally-funded research involving human participants, whether it is conducted inside or outside the U.S.

But those rules have not always been in place, and there are some shameful chapters in the history of medical research supported by the United States that include violations of the most basic standards of ethical behavior.  This history has left some people deeply suspicious of clinical trials and the motives of those who conduct them. Many explain their suspicion with one word: “Tuskegee.”

Read the rest.


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

How Would a PrEP Rollout Impact the HIV Epidemic?

via AIDS: Official Journal of the International AIDS Society, by El-Sadr, Wafaa M.; Coburn, Brian J.; Blower, Sally M.

Background

The HPTN 052 study demonstrated a 96% reduction in HIV transmission in discordant couples using antiretroviral therapy (ART).

Objective

To predict the epidemic impact of treating HIV discordant couples to prevent transmission.

Design

Mathematical modeling to predict incidence reduction and the number of infections prevented.
Methods

Demographic and epidemiological data from Ghana, Lesotho, Malawi and Rwanda were used to parameterize the model. ART was assumed to be 96% effective in preventing transmission.

Results

Our results show there would be a fairly large reduction in incidence and a substantial number of infections prevented in Malawi. However, in Ghana a large number of infections would be prevented, but only a small reduction in incidence. Notably, the predicted number of infections prevented would be similar (and low) in Lesotho and Rwanda, but incidence reduction would be substantially greater in Lesotho than Rwanda. The higher the proportion of the population in stable partnerships (whether concordant or discordant), the greater the effect of a discordant couples intervention on HIV epidemics.

Conclusions

The effectiveness of a discordant couples intervention in reducing incidence will vary among countries due to differences in HIV prevalence and the percentage of couples that are discordant (i.e., degree of discordancy). The number of infections prevented within a country, as a result of an intervention, will depend upon a complex interaction among three factors: population size, HIV prevalence and degree of discordancy. Our model provides a quantitative framework for identifying countries most likely to benefit from treating discordant couples to prevent transmission.


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