PrEP Evaluated on Possible Cost Issues that May Rise

via Pharmalot.com, by Ed Silverman

Late last year, Gilead Sciences took a widely anticipated and controversial step by seeking FDA approval to market its Truvada HIV pill to prevent infection, which is also known as pre-exposure prophylaxis or PrEP. The move was both welcomed and criticized by AIDS activists, reflecting a spectrum of views on making a preventive pill available on a large-scale basis.

To some, FDA approval would offer needed assistance in containing HIV and possibly clarify the extent to which such preventive measures are useful. To others, FDA approval raises the specter of creating a form of resistance to HIV due to widespread use, which would undermine effectiveness for existing Truvada patients and, therefore, diminish prevention efforts. In particular, critics worry people without HIV who take a preventive pill may engage in risky behavior.

A related issue, of course, is cost. Truvada carries a price of $26 a day, or roughly $10,000 a year, which may inhibit widespread usage. However, a new study suggests there is, indeed, value. Prescribing Truvada to men who have sex with men in the US would cost $495 billion over 20 years, but targeting only those at highest risk would lower costs to $85 billion, according to the study published in The Annals of Internal Medicine (here is the abstract).

Over the next two decades, the researchers calculated a total of 490,000 new infections if prevention is not undertaken, but if 20 percent of gay men take the pill daily, there would be nearly 63,000 fewer infections. And if just 20 percent of high-risk men took the drug, 41,000 new infections would be prevented over 20 years at a cost of about $16.6 billion.

“Promoting PrEP to all men who have sex with men could be prohibitively expensive,” Jessie Juusola, a PhD candidate in management science and engineering in the Stanford School of Engineering and first author of the study, says in a statement. “Adopting it for men who have sex with men at high risk of acquiring HIV, however, is an investment with good value that does not break the bank.”

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.]

The Debate Surrounding PrEP

via a&u, by Jeannie Gibbons

Post-exposure prophylaxis (PrEP) is the provision of antiretrovirals (ARVs) to HIV-negative people in order to prevent HIV infection. In light of recently released data, a heated debate is raging in the HIV community on how and if PrEP should be implemented. A vast array of ethical, financial, and medical concerns have been expressed, in fact too many to address in one article. However, most agree that PrEP (with more research), although not a single solution to preventing the continued spread of HIV, should be added to the arsenal of HIV prevention strategies where it is needed most.

Many contend that PrEP cannot be justified at the present time in all populations while millions already living with HIV are in desperate need of treatment. At the same time, the need for additional effective prevention methods, particularly among serodiscordant couples, men who have sex with men who practice unsafe sex, and disenfranchised women is immense, leading most to agree that PrEP should be explored for these groups.

Despite the concerns regarding PrEP, many in the HIV community view the recent PrEP data as a dramatic step and a valuable tool in reducing HIV transmission. “We’re excited about PrEP,” states Frank Oldham, president and CEO, National Association of People with AIDS. “Not because it will end HIV in America. It won’t and can’t. The epidemic is caused as much by poverty, homophobia, and an unfair healthcare system as it is by a virus, and no prevention tool, however promising, is going to end it until we do something about those problems. But PrEP has real promise for people for whom other prevention tools aren’t working—like sex workers, homeless youths, and women who aren’t in a position to negotiate safer sex with their partners. PrEP isn’t for everyone. We need to know more about its safety for women and adolescents. We need safeguards to make sure it isn’t given to people who already have HIV. But used wisely PrEP will save lives.”

Michael Ruppal, executive director of The AIDS Institute, echoes NAPWA’s concerns for caution and more data as well as their enthusiasm for PrEP’s potential. “The study data about PrEP offers some of the most exciting hope for stopping the transmission of HIV. With that comes a responsibility to be diligent to do more to answer long-term questions such as drug safety, efficacy, cost, access and ensuring additional studies. We all have a responsibility to educate ourselves and others about the truths surrounding PrEP and not let myths and fear drive our actions.”

Perhaps the greatest concern voiced by those both supportive and critical of PrEP is the high cost of this prevention modality. Close monitoring is essential for those on PrEP, adding to the cost of its use. Frequent HIV testing is necessary to prevent drug resistance from occurring from the use of suboptimal therapy if a person unknowingly seroconverts. Routine monitoring for ARV-related toxicities and adverse events, particularly kidney damage, loss of bone density, and changes in fat metabolism, which have been observed in clinical trials, must be conducted, as well as additional research to measure the long-term effects of ARVs on HIV-negative individuals.

In the iPREX study condom use was reported at ninety percent. Although self-reported adherence is not always accurate, the question if this high rate could be sustained under real world circumstances where counseling and safe sex education is not provided frequently as it was in the iPREX study has arisen. Could PrEP actually increase the risk of infection for some who, under the guise of being protected from infection by PrEP, discontinue using condoms?

Read the rest.


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

Optimal use of ARVs for Prevention in Serodiscordant South African Couples

via PLoS Medicine, by Timothy B. Hallett1, Jared M. Baeten, Renee Heffron, Ruanne Barnabas, Guy de Bruyn, Íde Cremin, Sinead Delany, Geoffrey P. Garnett, Glenda Gray, Leigh Johnson, James McIntyre, Helen Rees, Connie Celum

Background

Antiretrovirals have substantial promise for HIV-1 prevention, either as antiretroviral treatment (ART) for HIV-1–infected persons to reduce infectiousness, or as pre-exposure prophylaxis (PrEP) for HIV-1–uninfected persons to reduce the possibility of infection with HIV-1. HIV-1 serodiscordant couples in long-term partnerships (one member is infected and the other is uninfected) are a priority for prevention interventions. Earlier ART and PrEP might both reduce HIV-1 transmission in this group, but the merits and synergies of these different approaches have not been analyzed.

Methods and Findings

We constructed a mathematical model to examine the impact and cost-effectiveness of different strategies, including earlier initiation of ART and/or PrEP, for HIV-1 prevention for serodiscordant couples. Although the cost of PrEP is high, the cost per infection averted is significantly offset by future savings in lifelong treatment, especially among couples with multiple partners, low condom use, and a high risk of transmission. In some situations, highly effective PrEP could be cost-saving overall. To keep couples alive and without a new infection, providing PrEP to the uninfected partner could be at least as cost-effective as initiating ART earlier in the infected partner, if the annual cost of PrEP is <40% of the annual cost of ART and PrEP is >70% effective.

Conclusions

Strategic use of PrEP and ART could substantially and cost-effectively reduce HIV-1 transmission in HIV-1 serodiscordant couples. New and forthcoming data on the efficacy of PrEP, the cost of delivery of ART and PrEP, and couples behaviours and preferences will be critical for optimizing the use of antiretrovirals for HIV-1 prevention.

Read the full study here.


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

HIV No Longer a Death Sentence, but Many With HIV Still Undiagnosed, Untreated

via HIV Medicine Association

Significant strides in therapy and care have transformed HIV from a death sentence into a manageable chronic disease – but only when patients are diagnosed, receive good care and needed services, and take their medication. To ensure that all patients benefit, the HIV Medicine Association (HIVMA) and Ryan White Medical Providers Coalition (RWMPC) today published a policy paper in the journal Clinical Infectious Diseases describing the essential components of a comprehensive HIV care program and calling for innovative payment mechanisms and continued public health funding to support this care and expand it those who need it.

Of the nearly 1.1 million people with HIV, 20 percent don’t know they have the disease, and only 50 percent of people with HIV in the United States have reliable access to HIV treatment, which the recent HPTN 052 study showed not only saves lives but dramatically reduces sexual transmission of HIV from an infected partner to an uninfected one. More than 11,000 people still die of AIDS every year and thousands more are in poor health and struggling.

“HIV medicine is an incredible success story, and people with the virus are now living long, full lives thanks to improved therapy and comprehensive care,” said Joel Gallant, MD, lead author of the policy paper and a member of the HIVMA board of directors. “But it’s imperative that people learn their HIV status and get effective treatment. We have good strategies to achieve this, but it requires an integrated team approach, expertise, and a commitment to investing resources upfront that will reduce health care costs over the long-term.”

The president’s National HIV/AIDS Strategy and the Patient Protection and Affordable Care Act are providing an unprecedented opportunity to expand access to effective care shown to improve patients’ health and prevent new infections. But to turn this opportunity into reality, and to sustain the great gains made against this disease, it is critical that the essential components of HIV care be incorporated as health care reform is implemented. The U.S. government-funded Ryan White program has been critical to supporting the HIV care model, but as demand for care grows, innovative payment mechanisms for the Medicaid program, which covers 47 percent of people with HIV in care, are urgently needed. As health coverage is expanded, patients’ lives and our nation’s public health will be at risk if we do not build on the HIV care model and continue successful programs like Ryan White.

Read the rest.


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

AIDS Treatment is a Good Value!

via PLoS ONE and Results for Development Institute, by Stephen Resch1, Eline Korenromp, John Stover, Matthew Blakley, Carleigh Krubiner, Kira Thorien, Robert Hecht, Rifat Atun

Despite the remarkable scale-up of AIDS treatment and prevention programs in low and middle income countries in recent years, each year two million people die from AIDS (most without ever having received antiretrovirals ART) and 2.7 million are newly infected by HIV.

A study released in PLoS ONE, co-authored by a group from Results for Development Institute and the Global Fund, argues that large scale investment in ART in low and middle income countries yields a stream of economic benefits that is likely to offset substantially or exceed the costs of delivering AIDS treatment to millions of patients in these countries.

The study, The Economic Returns to Investment in AIDS Treatment in Low and Middle Income Countries, is one of the first efforts to look systematically at the expected economic benefits (returns) to large scale investment in AIDS treatment.

The study models three streams of future economic benefits accruing to the roughly 3 million persons who were on Global Fund supported treatment in 2010 in 98 countries around the world: (1) restored labor productivity amongst workers with AIDS, (2) orphan care expenditures avoided because parents remain alive on ART, and (3) delayed end-of-life care costs associated with death from AIDS. These streams of economic benefits were selected because they offset the cost of treatment over short time horizons and therefore may be especially salient to policy-makers concerned with health budgets, household economic stability and societal-level economic growth.

Using recent ART prices and program costs, the study estimates that the discounted resource needs required for this cohort of patients over the coming decade are US$14.2 billion.This investment is expected to save 18.5 million life years and return $12-34 billion. This yields economic benefits from ART ranging from 80% to 290% of program costs

Read the rest.


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

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.]

Obama Pushes More Competition on Biologic Drugs

via The New York Times, by Andrew Pollack

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology.

Tucked into the president’s deficit reduction plan released on Monday was a proposal to reduce the market exclusivity offered to brand-name biologic drugs to seven years, down from the 12 incorporated in the 2010 federal health care legislation.

That would allow so-called generic versions of such drugs to reach the market sooner, saving an estimated $3.5 billion in federal health spending over 10 years, or a little over one-tenth of 1 percent of the $3 trillion the president’s deficit reduction plan is supposed to save in a decade.

Biologic drugs are proteins made in living cells, like Avastin and Herceptin for cancer and Enbrel and Humira for rheumatoid arthritis. Such drugs can cost tens of thousands of dollars a year and are not subject to the same rapid onset of generic competition as drugs made in chemical factories, like Lipitor and Prozac.
The issue was a thorny one during the debate in Congress over the health care legislation.

The biotechnology industry argued it needed 12 years of freedom from lower priced competition to recoup research and development costs. Any less, it argued, would retard innovation. The generic industry, as well as many insurers and employers who pay health care bills, said a much shorter period would suffice.

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

Harvard School of Public Health to study "unique combination of HIV prevention strategies" in Botswana

via The Financial

A new four-year, $20 million grant from the U.S. Centers for Disease Control and Prevention (CDC) will enable Harvard School of Public Health (HSPH) researchers to evaluate the impact and cost-effectiveness of a unique combination of HIV prevention strategies in Botswana. The CDC grant is part of a U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) initiative that commits $45 million to examine the effectiveness of combination approaches to HIV prevention over four years. The largest evaluation of its kind, the research initiative is poised to help partner countries strengthen their efforts to prevent new HIV infections and save lives.

Principal investigator Max Essex, professor of health sciences and chair of the Harvard School of Public Health AIDS Initiative, and co-principal investigator Victor De Gruttola, professor of biostatistics and chair of the Department of Biostatistics at HSPH, predict that their prevention strategies can reduce HIV infection by at least 50 percent.

Read the rest.
 

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

How Much Would it Cost to End AIDS?

via Bloomberg, by Simeon Bennet

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

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

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

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

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

Read the rest.


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

Millions will die if India stops AIDS drugs

Via Reuters, by Nita Bhalla.

The EU and India are currently negotiating a free-trade agreement, which campaigners say will restrict India's ability to produce anti-retroviral (ARV) drugs, preventing the world's poor from accessing cheap drugs for their treatment.

"India should resist removing any flexibility because any trade agreement which could lead to India not being able to produce will be terrible for the rest of the world," said Michel Sidibe, executive director for the Joint United Nations Programme on HIV/AIDS (UNAIDS).

"Millions of people will die if India cannot produce and Africa will be the most affected. For me, it is an issue of life or death," he told Reuters in an interview, adding that about 86 percent of people on treatment were taking drugs made in India.

The EU-India trade deal includes measures that could delay or restrict competition from generic medicines by extending patent terms, requiring data exclusivity and tightening border enforcement rules.

Such moves could drive up prices for India's anti-retroviral treatments, limit dosage options and delay access to newer and better drugs, said a U.N. report in September last year.


REVERSING GAINS MADE

Thirty years after the HIV/AIDS virus was first discovered, experts say while substantial progress has been made by the global community in stemming it, only a fraction of those living with the illness are on medication.

At a high level U.N. meeting last month, nations agreed on a set of ambitious targets to rid the world of disease, including scaling up the provision of generics to reach 15 million patients from six million by 2015.
The trade deal, Sidibe said, would reverse many of the gains made in improving the lives of the world's poor.

Read the rest here.

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

Understanding the barriers to PrEP uptake

While formulating PrEP strategies, it is imperative that we, the HIV/AIDS prevention community, take into account the target community's concerns. By understanding the possible barriers and coming up with solutions, we can help ensure maximum possible effectiveness.

As per the findings of a study conducted in Peru and published in the International Journal of STD and AIDS, significant barriers among at-risk groups include concerns about cost, efficacy, and side-effects. The study was conducted by a team of researchers from UCLA and Lima, Peru; it included female sex workers, male-to-female transgendered individuals, and MSM.

To know more, check out aidsmap's round-up of the study here and EurekAlert!'s detailed article here.

On a related note, the Mapping Pathways project is also in the process of trying to gather perspectives on these questions from folks in our current focus areas – the US, South Africa, and India. If you’re interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – we encourage you to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

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

HPTN 052: Responses, benefits and challenges

The HPTN 052 study's compelling interim results on "treatment as prevention" are eliciting strong reactions from various players in the HIV/AIDS prevention community. According to UNAIDS, "the breakthrough is a serious game-changer", and AVAC has stated that "the upcoming UN High Level Meeting on AIDS should set treatment and prevention targets that take the HPTN 052 results into account." Other have voiced concerns that the evidence may not be compelling enough for some segments; for instance, in Sub-Saharan Africa, where most people remain untested, the methodology used in the HPTN 052 study may not be as effective as hoped.

There are other critical questions as well: How will we improve rates of diagnosis without coercion? How will governments and communities build the capacity to treat people with HIV promptly and effectively? What are the cost implications?

A few days ago, aidsmap published an excellent article, tackling these issues and concerns. To read more about the reactions, the possible benefits, the challenges and proposed solutions, and the dollars-and-cents issues, click here.

Also, folks from the US, South Africa and India who are interested in new ways to prevent transmission of HIV – and want to help shape our project goals and deliverables – are highly encouraged to take a few minutes and fill in our survey.

Your efforts will be greatly appreciated!

Take the survey now.

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