HIV Treatment Breakthrough: Weekly Injection Could Replace Daily Pill Regimen

HIV-1 Gag

HIV-1 Gag (Photo credit: AJC1)

For a number of people with HIV, treatment can be troublesome because medicine should be taken at the same time every day- sometimes more than once a day. Some medications must be taken with food, some without. Some can only be taken near bedtime because they cause drowsiness.

Science Daily reports a treatment breakthrough:

(A) University of Nebraska Medical Center research team’s progress toward developing weekly or twice-monthly injectable antiretroviral therapy (ART) nanomedicines for patients with human immunodeficiency virus (HIV) infection will be highlighted as the cover story in the Journal of Infectious Diseases.

A long-acting, nanoformulated ART (nanoART) would be a substantive improvement over daily and sometimes more complex regimen of pills, said Howard Gendelman, M.D., the lead investigator on the development of nanoART for HIV/AIDS and professor and chairman of the department of pharmacology and experimental neuroscience (PEN) at UNMC.

The journal article hails the successful testing of UNMC’s ART injectables as treatment of HIV-infected mice and in preventing new infections.

“We actually followed the process exactly as we would with a person — and it worked,” Dr. Gendelman said. “This is all very exciting. Although there are clear pitfalls ahead and the medicines are not yet ready for human use, the progress is undeniable.”

This could prove to be helpful- most especially in the developing world- where people have trouble managing a regimen of pills or have low access to long-term medication treatments. But it may have significant impact everywhere, changing the way HIV is treated….

Full article here.

Stem Cells: Killing HIV

From Science Daily:

Human Immunodeficiency Virus (public domain)

Expanding on previous research providing proof-of-principal that human stem cells can be genetically engineered into HIV-fighting cells, a team of UCLA researchers have now demonstrated that these cells can actually attack HIV-infected cells in a living organism.

The study, published April 12 in the journal PLoS Pathogens, demonstrates for the first time that engineering stem cells to form immune cells that target HIV is effective in suppressing the virus in living tissues in an animal model, said lead investigator Scott G. Kitchen, an assistant professor of medicine in the division of hematology and oncology at the David Geffen School of Medicine at UCLA and a member of the UCLA AIDS Institute.

“We believe that this study lays the groundwork for the potential use of this type of an approach in combating HIV infection in infected individuals, in hopes of eradicating the virus from the body,” he said.

Full story here.

Analysis: Why some people do not receive continuous HIV medical care

by Chris Morley

Only 42% of the people diagnosed with HIV in the USA receive continuous HIV medical care after their diagnosis (seeing their HIV doctor at least every six months), according the the first national study in the USA.

  • 28% had a gap of at least one year between HIV medical check ups
  • 31% let 7-12 months pass between their appointments.

Who are the people missing care some of the time and what are their reasons? What are the consequences and what might be done to reduce the harm?

Over 17,000 adults attending 12 clinics within the HIV Research Network across the country, were surveyed by the Perelman School of Medicine, Pennsylvania, who reported their findings in the online journal AIDS in March 2012. This summary is based on a report in Medical News Today.

Why continuous HIV care is better

  • People with HIV whose health is regularly monitored and treated are less likely to become sick
  • People receiving continuous treatment are far less infectious and this very significantly reduces the spread of HIV
  • Regular attendance cuts total health costs by preventing serious health problems from developing that require expensive hospital treatment.

So regular, frequent HIV care means better longer term health for the person with HIV, fewer new people becoming infected, and lowers HIV health costs.

Who’s more likely to attend regularly for HIV care?

  • Patients who begin treatment on Medicare, not private insurance
  • Older patients
  • Men infected through sex with men
  • White patients
  • Women
  • People with very low CD4 counts (or an AIDS diagnosis) on starting care.

Sometimes missing care

So we may assume that the people more likely to have gaps in their care (of over 6 months) will broadly be the mirror image:

  • People with private insurance
  • People without healthcare insurance
  • Younger people, including those infected by mother to baby transmission
  • People infected through Injecting Drug Use
  • Heterosexually infected people, most especially Heterosexual Men
  • African Americans, Hispanic people, Native Americans, other ethnic minorities and migrants

At risk of missing HIV care

The researchers themselves suggest that HIV healthcare providers should treat the following people as at risk of not attending as regularly as they should:

  • Symptomless people, who may think they are well enough to skip appointments
  • People with depression, anxiety, or with difficulties accepting their diagnosis, or with other mental health conditions
  • People using substances (alcohol, drugs)
  • People with practical difficulties in their lives: poverty or debts, long working hours or low wages, unable to take time off, poorly housed, with childcare responsibilities, with travel problems
  • People with other health conditions and disabilities
  • People who move home or district, especially if this is often
  • People who have changed doctors
  • People jailed, or otherwise institutionalised.

Future work

The study authors suggest standard criteria should be developed to decide the  appropriate gaps between appointments for people in different circumstances. Some people will need personalised care plans based on the stage of their HIV illness, and their particular social circumstances.

More studies are needed to pinpoint the times when some people are more likely to fail to appear for appointments, and to identify what works to ensure people do attend every time.

Using insurance records data may help track people through changing situations and help establish which are the patterns that lead to increased risk of missing continuous HIV medical care.

Other research and experience in other countries

With 68% of the people with HIV in this US study not attending for HIV check-ups and care at least once in every six months, the USA appears to have one of the worst national HIV care regular attendance records in the developed world. This is the first national USA study of HIV care attendance but other countries have been tracking HIV healthcare non-attendance for some years.

The USA can therefore benefit from using other countries’ experience to  help  understand better what is happening, and consider adopting solutions that have already been found to reduce the numbers missing HIV  appointments.

For example, in Northern France, 13% disappeared for at least 12 months immediately after their diagnosis, and over half of those returned after an average lapse of 19 months; but almost half of those returnees by then had a dangerously low CD4 count of under 200, and another one quarter returned and were then given an AIDS diagnosis.

3/4 of those who dropped out suffered serious health and life expectancy consequences. There was a more-than-fivefold increase in the chance of dying in the year after return, compared with people who had stayed in care.

Suggested ACTIONS for healthcare and clinical staff

  • Tell people, when giving the positive test result, that coming to ALL your appointments and taking treatment as recommended, keeps most people well, with a near normal life expectancy. That it is really important to come, even when you feel very well and have no symptoms.
  • AND the people who miss their appointments are five times more likely to die within the next 12 months than those who keep their appointments.
  • Do everything you can to obtain a wide range of ways to contact people, and permission to use all these, with discretion.
  • Send SMS text reminders a day or so before the appointment.
  • Quickly and rigorously follow up all people who don’t attend.
  • Strongly encourage people newly diagnosed to become an active user of a community HIV project as soon as possible. This is because contact with and seeing other people like themselves who are living well with HIV is immensely reassuring and supportive and also improves mental and physical well-being. It counters the  stigma and isolation of living with HIV. It provides a safe space to talk about HIV. The clinic’s messages will be  reinforced by what other people living with HIV and community volunteers and staff say. Clinic staff giving a positive diagnosis must understand that most people getting their HIV diagnosis will remember only fragments of the important information they are told by the clinic. The shock of diagnosis means many mishear and misinterpret the limited amount they do remember.

In London, UK, where free HIV treatment for all is provided through the National Health Service, a study at London’s King’s College Hospital found that 40% of the patients seen at least once between 1995 and 2005, were not seen at all during 2006. Crosschecks with the national anonymised HIV database held by the Health Protection Agency, found half (20%) were using another HIV clinic, a small number had died, but more than 1 in 5 (over 20%) of all their patients were completely missing from  HIV care throughout the snapshot year of 2006.

Compare that 20% missing with the 68% missing in the USA.

There are a wide range of studies from British and other countries’ HIV clinics using different measures, finding various levels of loss, a variety of common causes, and making a range of suggestions for action. A 20% attrition rate is about average.

Some hospitals are clearly better at retaining patients than others; some HIV clinics have many people with complex problems and needs; in the bigger cities where there is a choice of HIV treatment centres, there is some ‘churn’, people going to another hospital without telling the first, because they have moved or wanted a change.

There is a wealth of detailed information, exploration of the reasons people disappear, and suggestions for ways to reduce the loss of people from HIV care, in this detailed report of experiences in London and Manchester, UK

Lost to care: the mystery of the disappearing patients in HIV Treatment Update.

This is the most thorough resource available, incorporating lessons from a range of European studies. Reading and acting on the various findings is recommended.

Other useful papers 

Reaching Lost to Care Populations Clinical Infectious Diseases 2006, full text free online.

High rate of loss to clinical follow up among African HIV-infected patients attending a London clinic: a retrospective analysis of a clinical cohort. Journal of Int AIDS Soc. 2010, abstract.

Many Black, HIV-Infected Women in Mississippi Are Lost to Care After Giving Birth Interview with Aadai Rana MD The Body, 2008, with weblinks to two other resources 8

Differences and disadvantages in the USA

There are a number of reasons why it is more likely many people will miss HIV care appointments in the USA than in other countries. These help explain why only 42% of US people with HIV attend HIV clinic at least once every six months. This low rate of regular attendance means that HIV clinics in the USA must work very much harder to reduce the 68% of no shows.

  • US health care is often excellent but without doubt the most expensive in the world. Large numbers of people have no health insurance, or inadequate health insurance; there are problems accessing and with  inadequate funding for the public healthcare programs, Medicare and Medicaid.
  • HIV is an expensive healthcare condition to treat.
  • Co-infections and other co-morbidities are common, compounding treatment complexity, treatment adherence, and increasing health costs.
  • Distances to HIV treatment centres and travel difficulties may be considerable.
  • HIV stigma and discrimination seems particularly rife in many parts of the USA. There are no international data comparisons available yet, although the international HIV Stigma Index will help answer this need. Lambda Legal carried out a USA HIV stigma survey within US healthcare in 2009 and publish a factsheet detailing discrimination and stigma in HIV healthcare and elsewhere.

These and possibly other factors contribute significantly to the high rate of missed HIV appointments and loss to HIV care in the USA.

~Chris Morley is a community HIV policy and practice expert based in NW England. He researched and co-authored for the UK’s HIV Treatment Update: Lost to care: the mystery of the disappearing patients.

He’s worked on a wide range of English national and regional HIV policy and practice issues including

  • making free HIV treatment available to all migrants
  • ending the prosecution of people living with HIV for HIV transmission
  • promoting the use of HIV treatment as part of the HIV prevention toolkit
  • developing support for gay men living with HIV on using HIV treatment to prevent onward transmission
  • making gay men’s HIV prevention work friendly and relevant to gay men living with HIV
  • combating HIV stigma and discrimination
  • supporting teenagers and children living with HIV in the care system
  • readying adult HIV services for older teenagers to transfer
  • developing services for older people living with HIV

Kaiser Permanente Announces HIV Challenge

When healthcare gets it right, I think it’s important to notice.
Contrary to the HMO stereotype, Kaiser Permanente has taken on the challenge of HIV and instituted policies and guidelines for the effective care and treatment of persons with HIV- to dramatic effect:

English: The Ordway Building, One Kaiser Plaza...

Image via Wikipedia

Kaiser Permanente announced (January 26th) the Kaiser Permanente HIV Challenge to help health care providers nationwide improve health equity for people living with HIV by increasing access to HIV care and improving health outcomes.

The HIV Challenge was announced at the Center for Medicare & Medicaid Innovation Care Innovations Summit in Washington, D.C. ( www.hcidc.org ).

Kaiser Permanente, the nation’s largest nonprofit health care provider, has treated more than 60,000 people since the HIV epidemic emerged 30 years ago, and has reduced disparities among its current HIV population of more than 20,000 people by working to meet or exceed the objectives of the U.S. National HIV / AIDS Strategy.

The crux of the HIV Challenge (kp.org/hivchallenge) is to challenge other private health care providers and public and community health clinics to increase the number of HIV-positive people getting effective treatment by sharing Kaiser Permanente’s toolkit of clinical best practices, provider and patient education materials, mentoring, training and health IT expertise.

(Watch the excellent video series about Kaiser’s HIV Challenge here)

HIV is still an epidemic in the United States, with 56,000 people becoming infected each year and more than 1.1 million Americans living with HIV, but one in five people with HIV don’t know they are infected.

“The organizations presenting challenges here today are pushing the best minds in the country to create a better health care system. They represent exciting solutions to help address some of the nation’s most urgent health needs,” said CMS Acting Administrator Marilyn Tavenner.

Health care disparities are gaps in the quality of care associated with inequities encountered by racial, ethnic, poor and marginalized groups. The HIV Challenge is part of Kaiser Permanente’s larger work to identify, measure, research and eliminate disparities in health and health care in the United States. To learn more go to kp.org/healthdisparities.

“Too many people are unaware they have HIV because access to effective prevention and care is insufficient,” said Michael Horberg, MD, director of HIV/AIDS for Kaiser Permanente, executive director of research for Mid-Atlantic Permanente Medical Group, and a member of the Presidential Advisory Council on HIV/AIDS. “People with HIV need to get into treatment because quality HIV treatment prevents others from getting infected. Patients on effective therapy and better case management are living longer and more productive lives. However, quality HIV treatment requires effort.”

Kaiser Permanente has demonstrated excellence in HIV clinical care outcomes with:

  • HIV mortality rates that are half the national average
  • 94 percent median treatment adherence among patients regularly in care and on antiretroviral therapy
  • No disparities among its black and Latino HIV-positive patients for both mortality and medication rates, compared to a 15 percent higher rate in the United States for mortality and for medication
  • 89 percent of its HIV-positive patients are in HIV-specific care within 90 days, compared to 50 percent in the U.S. within one year
  • 69 percent of all its HIV-positive patients have maximal viral control compared to 19 percent to 35 percent nationally

As part of its HIV Challenge effort, Kaiser Permanente is sharing these best practices and tools for private health care providers and community health clinics to replicate: quality improvement programs that measure gaps in care; testing, prevention and treatment guidelines; how to set up multi-disciplinary care team models that emphasize the “medical home” so HIV specialists, care managers, clinical pharmacists and providers work together; and education for both the provider and patient.

For more details on the HIV Challenge, to download the best-practices toolkit and to watch videos of success stories in setting up HIV clinics and reducing disparities, go to: kp.org/hivchallenge

“Our success in the treatment of patients with HIV/AIDS results from the excellence of our clinicians, our advanced IT systems, our integrated delivery system and our effective coordination across specialties,” said Robert Pearl, MD, chief executive officer and executive medical director of The Permanente Medical Group and Mid-Atlantic Permanente Medical Group. “In the same way that we have reduced the chances of our patients dying from cardiovascular disease and cancer significantly below the national averages, we have achieved outstanding clinical outcomes for our patients with HIV/AIDS.”

The National HIV/AIDS Strategy ( http://www.aids.gov/federal-resources/policies/national-hiv-aids-strategy/ ) calls for increased testing so that all Americans can know their HIV status, increased access to culturally sensitive prevention messages, community-targeted prevention and condom and clean needle access. NHAS also calls for improving access to quality HIV care because HIV medications not only improve individuals’ health and extend their life expectancy, they also reduce their risk of transmitting HIV to others. A recent scientific study found that effectively treating HIV patients with antiretroviral medications reduces HIV transmission by 96 percent. The study, known as HPTN 052, found that treating people with antiretroviral drugs before they are symptomatic can reduce the amount of virus in the blood sufficiently to reduce the risk of sexual transmission of HIV to an uninfected partner.

The Kaiser Permanente HIV Challenge is part of Kaiser Permanente’s ongoing research of HIV and HIV treatment. Published Kaiser Permanente research studies include:

  • A study that found there are no disparities by race or ethnicity in risk of AIDS and death among HIV-infected patients in a setting of similar access to care, despite lower anti-retroviral therapy adherence among Latinos and blacks compared to whites.
  • A study that found HIV-infected patients are at increased risk for cancer as a result of both their impaired immune system and lifestyle factors, such as smoking.
  • A study that found 17 measures, such as screening and prevention for infections and monitoring of antiretroviral therapy, should be adopted uniformly to improve the quality of HIV care and treatment nationwide.
  • A study that found that cholesterol medications can work well among certain HIV patients who are at risk for cardiovascular disease.

About the Care Innovations Summit:

Sponsored jointly by the Department of Health and Human Services, the Centers for Medicare & Medicaid Services, Health Affairs, and the West Wireless Health Institute, the Care Innovations Summit brings together more than 1,000 health care leaders, entrepreneurs, innovators, government officials, and finance experts to stimulate investment in a high-quality, sustainable health care system. Made possible by the Affordable Care Act and the Obama Administration’s commitment to open government, the Summit represents a new opportunity for industry and government to work together to help spur innovation in the public and private sectors to improve health care quality as never before and lower costs through improvement.

About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve 8.9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: http://www.kp.org/newscenter .

For more information:
Danielle Cass, danielle.x.cass@kp.org, 510-267-5354
Farra Levin, farra.r.levin@kp.org, 510-267-7364

SOURCE Kaiser Permanente

New York Times: Expanding HIV Treatment Necessary And Overdue

This hasn’t taken that long.

I’m blaming Hillary Clinton and Barack Obama.

The news that HIV treatment is prevention has taken a remarkably short time to hit the mainstream media, and it’s due to Secretary Clinton’s address to the NIH last month, and the President of The United States.

The NYT:

President Barack Obama announces a new compreh...

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Important new findings show that very early treatment of people infected with H.I.V. enhances their health and greatly lessens the likelihood that they will spread the virus that causes AIDS. We welcome the Obama administration’s announcement of a farsighted effort to treat millions more infected people abroad, especially in sub-Saharan Africa.

The administration expects that the expanded treatments can be paid for with existing resources, by pushing for greater efficiencies and more financing from recipient nations. But if that effort stalls, the administration should re-evaluate quickly whether to ask Congress for money.

… Mr. Obama also announced that he would commit an additional $50 million in this country in fiscal year 2012 to help pay for treatments at AIDS clinics and in-state programs that provide AIDS drugs to people who can’t afford them. The money may be drawn from $1 billion available through the health care reform law.

Working to get these changes made legislatively have proven impossible in a Republican-owned House and a Republican-bullied Senate- especially when it involves the health of gay and bisexual men- so policy and administrative action were required. And by beginning to make testing and immediate treatment for HIV routine, medical practices are established that will be hard to take back.

An estimated 1.2 million Americans were infected with the virus at latest count, of whom 240,000 people are unaware. The Centers for Disease Control and Prevention started a campaign last week to increase testing with special emphasis on warning black gay and bisexual men, whose infection rates have been soaring, to get tested and treated.

Meanwhile, the New York City Health Department became the second (after San Francisco’s) to recommend doctors offer drug therapy immediately to every person diagnosed as infected, instead of waiting for the virus to damage their immune systems. The city has made enormous strides in testing, treating and cutting the number of new infections. Some 110,000 infected residents are under treatment; aggressive testing might find another 2,500 immediately and perhaps 500 a year thereafter.

The investments here and abroad should pay off in the long run by reducing the number of people infected and easing the severity of illnesses.

Thanks to you both.

 

Another Reason To Start HIV Meds Early

From Science Daily:

Researchers at Weill Cornell Medical College and GHESKIO (Groupe Haitien d’Etude du Sarcome de Kaposi et des Infections Opportunistes) have shown that early treatment of HIV not only saves lives but is also cost-effective.

And the recommended blood levels of T-cells as markers to start treatment is creeping up:

Before 2009, the World Health Organization (WHO) recommended waiting to initiate antiretroviral therapy (ART) for HIV until a patient’s CD4+ T cells fall below 200 cells per cubic millimeter. But in that year, a randomized clinical trial completed by Weill Cornell researchers at the GHESKIO clinic in Port-au-Prince, Haiti, demonstrated that early ART decreased mortality by 75 percent in HIV-infected adults with a CD4 cell count between 200 and 350 cells/mm3. As a result, the WHO now recommends that ART is started in HIV-infected people when their CD4 cell count falls below 350 cells/mm3.

Full story here.

HIV: Treatment is Prevention

Today’s New England Journal of Medicine has an excellent research study on HIV, entitled Preventing HIV-1 Infection with Antiretroviral Therapy.

Scott Hammer,MD, in an editorial for the journal, gives a brief overview of the study:

In this issue of the Journal, Cohen et al. describe the results of the HIV Prevention Trials Network (HPTN) 052 study, which has now provided definitive proof that (as suggested by the findings of previous cohort studies) antiretroviral treatment reduces the rate of sexual transmission of HIV-1.

Did you hear that? Definitive proof.

Early antiretroviral treatment not only significantly lowers the risk of transmitting the virus, it also shows increased health benefits for the HIV infected. The conclusions by the research team in the article:

In conclusion, the biologic plausibility of the use of antiretroviral therapy for the prevention of HIV-1 infection has been carefully examined during the past two decades. The idea of HIV-1 treatment as prevention has garnered tremendous interest and hope and inspired a series of population-level HIV-1 treatment-as-prevention studies that are now in the pilot or planning stages. Such interventions are based on the hypothesis that the use of antiretroviral therapy reliably prevents HIV-1 transmission over an extended period of time. In this trial, we found that early antiretroviral therapy had a clinical benefit for both HIV-1–infected persons and their uninfected sexual partners. These results support the use of antiretroviral treatment as a part of a public health strategy to reduce the spread of HIV-1 infection. (emphasis mine)

This is science at work. Get tested. If you’re HIV-positive, get into care and take your meds. We can slow this thing down.

Money quote from Dr Hammer:

Antiretroviral therapy is by no means perfect and is not the ultimate answer to controlling and ending the HIV epidemic. Adverse events, emergence of drug-resistant viral strains, maintenance of adherence, sustainability, and cost are just some of the concerns. However, this is precisely the wrong time to limit access to antiretroviral therapy in resource-limited settings, since we have the tools in hand to maintain or restore health in infected persons and reduce transmission to their sexual partners.

Yep.
So now that we know, will anything happen?

(PS- the picture above is of my morning pills)