Research

“Tell me your life story, I’m listening, I see you.”

Posted on Sep 3, 2020 in California Pacific Medical Center, Community Benefit, Expanding Access, Health Equity, Innovation, Mental Health, People, Quality, Research, Scroll Images, Sutter Medical Center of Santa Rosa, Sutter Medical Center, Sacramento

Faculty and residents in Sutter’s Family Medicine Residency Program

We are a mosaic of our experiences, lifestyle, social and family connections, education, successes and struggles. Apply those factors to our health, and a complex formula arises that clinicians commonly call the patient experience.

Learning the skills to assess these factors and deliver compassionate care to patients is what Sutter’s family medicine resident physicians aim to enhance. The newly enhanced Human Behavior & Mental Health curriculum is helping lead the way.

“We encourage faculty and residents to think about context, systems and dynamics within population health to address social determinants of health,” says Samantha Kettle, Psy.D., a faculty member in Sutter’s Family Medicine Residency Program.

She and colleague, Andy Brothers, M.D., a family medicine physician in Sacramento and faculty member in the residency program, are bringing health equity to the patient experience and training family medicine residents in Sacramento and Davis.

Family medicine faculty and residents at Sutter Medical Center, Sacramento

Seven residents each year learn to screen patients for social determinants of health (such as financial challenges, environmental and physical conditions, transportation needs, access to care and social factors) that may impact patients’ risk of depression and anxiety, substance use disorder and suicide.

This year’s residents may train in addiction medicine, psychotherapy, chronic pain, spirituality in medicine, well-being and the field of medicine that supports those who are incarcerated.

And in a community as diverse as the Sacramento Valley Area, statistics suggest these factors may significantly impact the health of its residents:
• 15.9% of California adults have a mental health challenge(1)
• Nearly 2 million Californians live with a serious mental challenge
• Substance misuse impacts 8.8% of Californians
• The prevalence of mental health challenges varies by economic status and by race/ethnicity: adults living 200% below the federal poverty level are 150% more likely to experience mental health challenges; 20% of Native Americans and Latinos are likely to have mental health struggles, followed by Blacks (19%), Whites (14%) and Asians (10%).

“Taking care of our local population’s health is a moral imperative,” says Dr. Kettle. “Many residents have entered our program to continue their quest in helping people in underserved communities.”

For instance, third-year Sutter family medicine resident Mehwish Farooqi, M.D., is studying ways to screen for post-partum depression using an approach developed through the ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program.

“Women are most vulnerable to mental health concerns during the post-partum period: as many as one in seven women experience PPD. ROSE is a group educational intervention to help prevent the diagnosis, delivered during pregnancy. It has been found to reduce PPD in community prenatal settings serving low-income pregnant women,” says Dr. Farooqi.

“Sutter has clearly demonstrated a commitment to health equity and social justice that has propelled our residency program toward a future vision of health care in which all patients are cared for as individuals with unique life stories, struggles and successes,” says Dr. Brothers.

Advancing Social Determinants of Health through Graduate Medical Education at Sutter:
Other family medicine programs across Sutter’s integrated network incorporate health equity into ambulatory training for residents. The family medicine faculty at California Pacific Medical Center include a social worker who teaches residents to address concerns like financial and food insecurity, as well as social isolation. Residents learn how to care for people with depression and anxiety, and lecture series are offered on topics like addiction medicine and chronic pain/narcotic management.

Sutter Santa Rosa Regional Hospital’s Family Medicine Residency Program incorporates social justice through a Community Engagement and a Diversity Action Work Group—a committee comprised of faculty and residents who help tackle issues around inequity and structural racism.

“We are committed to strengthening a relationship between the residency program and the diverse communities we serve, guided with cultural mindfulness and compassion in our pursuit of overall wellness for all,” says Tara Scott, M.D., Program Director of the Family Medicine Residency Program in Santa Rosa.

Learn more about Sutter’s Family Medicine Residency Program.
• Find out how Sutter is advancing health equity.

Reference:

  1. California Department of Health Care Services.

An Immune Boost Toward COVID-19 Vaccines

Posted on Aug 18, 2020 in Affiliates, Innovation, Quality, Research, Scroll Images

Microscopy image of the novel coronavirus, COVID-19

As the COVID-19 pandemic continues to persist worldwide, few features of the human body have figured as prominently on center stage as the immune system.

How does the immune system respond to viruses?
One function of the human immune system is to inhibit viruses, and prevent them from causing illness. The body has two types of immune response to accomplish this function: innate immunity, which starts within hours of an infection, and adaptive immunity, which develops over days and weeks.

A virus causes an illness by infecting cells in the body and taking control of their genetic material. The virus then instructs these infected cells to reproduce the virus’s genetic code and replicate more viral “soldiers” that fight against our immune system.

The body’s adaptive immune response consists of two types of white blood cells—called T and B cells—that can detect “signals” specific to the virus and assemble a targeted response to it.

T cells identify and kill cells infected by a virus. B cells make antibodies—a kind of protein that blocks viral material from entering our cells and prevents the virus from reproducing.

In case the body may need to fight the same virus again, the body stores T and B cells that helped eliminate the original infection. These “memory cells” help provide us with long-term immunity. How long is long-term? Antibodies produced in response to a common, seasonal virus last for approximately one year. But the antibodies generated in response to a measles infection, for example, can provide lifelong protection.

Antibodies, a critical component of the human immune system

The human immune system and vaccines
Vaccines provide immunity, or protection against a disease without causing the illness. They are made using killed or weakened versions—called antigens—of the disease-causing virus. For some vaccines, genetic engineering is used to make the antigens included in the vaccine.

If you’re administered a vaccine to prevent viral infection, your immune system responds to the vaccine in the same way it would if exposed to the actual virus, by: recognizing the proteins and other components of the vaccine as foreign; making antibodies to “attack” the vaccine, as if it were the actual virus, and; remembering the foreign invader and how to destroy it. This response means if you are exposed to the disease-causing virus again, your immune system can intervene before you get sick.

The science on COVID-19 vaccines
Worldwide, scientists are studying more than 165 vaccines against COVID-19. Thirty are being tested in clinical trials in humans, and three of those are in Phase 3 studies.(1) Vaccines typically require years of research and testing before reaching the marketplace or clinic, but scientists are attempting to develop a safe and effective COVID-19 vaccine by next year if not sooner.

Each of the COVID-19 vaccines being tested use a different method to “attack” the virus and engage the immune system to fight infection. But to date, there are a few common approaches being studied in clinical trials:(1, 2)

1. Genetic vaccines use one or more of the COVID-19 virus’s genes to provoke an immune response, using genetic material called messenger RNA (mRNA) or DNA to produce viral proteins in the body.
2. Repurposed vaccines rely on vaccines already being used to protect humans against other diseases (e.g., tuberculosis) that may also be effective in protecting against COVID-19.
3. Viral vector vaccines use a virus to deliver COVID-19 genes into cells and provoke an immune response. These vaccines typically use viruses that infect animals such as chimpanzees or monkeys to act as the “carrier” that prompts an immune response against COVID-19 in humans.
4. Whole-virus vaccines use a weakened or inactivated version of COVID-19 to spark an immune response.
5. Protein-based vaccines use a COVID-19 protein or its pieces to invoke an immune response against the virus.

Sutter Health anticipates studying a COVID-19 vaccine being tested in humans through a Phase 3 clinical trial. Stay tuned for more news next month! Curious about other research at Sutter? Learn more.

References:

  1. World Health Organization. Accessed Aug. 11, 2020.
  2. The race for coronavirus vaccines: a graphical guide. Nature news feature, April 2020.

A Conversation Guide: COVID-19 Medical Research Terms Defined

Posted on Jun 22, 2020 in Affiliates, Community Benefit, Expanding Access, Innovation, Quality, Research, Safety, Scroll Images

Investigational Treatments
Researchers conduct clinical trials to study investigational or experimental treatments to determine if potential new treatments, such as drugs and medical devices, can safely and effectively prevent or treat disease or other health concerns. Clinical trials of potential new drugs can also provide information on how much of a drug is needed, what benefits and side effects may occur, and how drugs or other interventions impact individuals differently based on age, gender, and race/ethnicity.

Drug and medical device development is most commonly conducted in several phases:
Preclinical tests: Before clinical trials involving humans are conducted, potential treatments are first assessed in preclinical research. Such preclinical research assesses the features of a test or treatment. For example, the research may aim to learn if a device is harmful to humans. Another aim may be to learn more about the chemical composition of a drug. In preclinical studies of vaccines, researchers give the vaccine to animals to see if it produces an immune response.

Phase 0: These studies are the first clinical trials conducted in humans. They aim to learn how a drug is processed in the body and how it affects humans. In these trials, a very small dose of a drug is given to about 10 to 15 people.

Phase 1: These studies assess the safety of a drug or device. This phase of testing, which can take several months to complete, usually includes a small number of healthy study participants (20 to 100 people). Phase 1 studies aim to better understand the effects of the drug or device on humans. For drug studies, this may include how the drug is absorbed, metabolized or excreted in humans, and what side effects may occur as dosing increases. In Phase 1 studies of vaccines, researchers give the vaccine to a small number of people to test safety and dosage, and confirm that it stimulates the immune system.

Phase 2: Phase 2 studies test the effectiveness of a drug or device over several months to two years, and involve up to several hundred patients. Most Phase 2 drug studies are randomized trials where one group of patients receives an experimental drug, while a second “control” group receives a standard treatment or placebo. Often these studies are “blinded,” meaning neither the study participants nor the researchers know who has received the experimental drug or other intervention. With such an approach, comparative information can be generated about the relative safety and effectiveness of the new drug, device or other intervention.

In Phase 2 studies of vaccines, researchers give the proposed vaccine to hundreds of people split into groups to see if the vaccine acts differently among the various groups of study participants. These trials seek to further test the proposed vaccine’s safety and ability to stimulate the immune system.

Phase 3: These studies involve randomized and blind testing in several hundred to several thousand study participants. This large-scale testing, which can last several years, seek to provide the manufacturer of a proposed treatment with a thorough understanding of the effectiveness of the drug or device, as well as the benefits and the possible adverse reactions or side effects. Once Phase 3 is complete, a pharmaceutical company or medical device company may use the data generated and collected from the performance of the Phase 3 study in order to request FDA approval to market the drug or medical device.

In Phase 3 studies of vaccines, researchers give the vaccine to thousands of people and wait to see how many become infected, compared with study volunteers who received a placebo. These trials can determine if the vaccine protects against COVID-19, for example.

Phase 4: These studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer use. Pharmaceutical and medical device companies have several objectives at this stage: to compare a treatment with other similar treatments already in the market; monitor the treatment’s long-term effectiveness and impact on a patient’s quality of life, and; to determine the cost-effectiveness of a particular approved treatment relative to other traditional and new therapies.

In Phase 4 studies of vaccines, regulators in each country review the trial results and decide whether or not to approve the vaccine. During a pandemic, a vaccine may receive emergency use authorization before formal approval.

Expanded Access
Sometimes called “compassionate use,” expanded access is a potential route for patients with a serious or life-threatening disease to gain access to an investigational drug or device where there is no comparable, alternative therapy, but the patient’s clinician, in coordination with the pharmaceutical or medical device company, believes that the particular treatment may be beneficial to the patient if applied. Expanded access use of a drug or device is done outside of the clinical trial context, but, as with clinical trials, also involves regulatory and reporting obligations to the FDA.

As of June 2020, expanded access is one pathway advancing the use of convalescent plasma for patients with serious COVID-19, who are not otherwise eligible for or who are unable to participate in clinical trials.

Emergency Use Authorization
An Emergency Use Authorization (EUA) is one way the FDA makes certain medical products (drugs, tests, vaccines) available quickly during a pandemic. The FDA may issue an EUA to provide access to these products when there are no adequate, approved options.

Under an EUA, in an emergency, the FDA provides access to the public based on the best available evidence, without having all the evidence that would normally be needed for full FDA approval. The FDA balances the potential risks and benefits of the medical products based on the data currently available.

EUAs can be revised or revoked by the FDA at any time as the agency continues to evaluate the available data and patient needs during a public health crisis like a pandemic.

“Off-Label” Use of an Approved Drug
After the FDA approves a drug for a certain disease or health condition, doctors may prescribe the drug in clinical care for an use not specifically listed in the approved labeling (i.e., “off-label”) based on the physician’s medical judgment, but recognizing that the FDA has not assessed the safety or effectiveness of such use.

For example, in April 2020 the FDA acknowledged that certain off-label use of the antimalarial drugs hydroxychloroquine and chloroquine had been prescribed by physicians for the treatment of COVID-19. These drugs have been FDA approved for use in treating malaria, but not for widespread use in treating COVID-19 since no formal clinical trials had been previously conducted to examine the efficacy of the drugs for this purpose. The FDA thus did not have data necessary to support an approved use of hydroxychloroquine or chloroquine.

“FDA Approved”
The FDA is the national regulatory agency that among its various duties, approves drugs, medical devices, and vaccines based on clinical data and other information showing that the treatment is safe and effective for its intended use and in compliance with federal quality standards. The “stamp of approval” is provided when the FDA determines that the benefits of a drug, device of other medical product outweigh its risks.

Learn more about clinical research and the phases of clinical trials.

The Unseen Risk of Parkinson’s Disease

Posted on Jun 5, 2020 in California Pacific Medical Center, Expanding Access, Innovation, Quality, Research, Scroll Images

Older patients with Parkinson’s disease also often suffer from a very high risk of falls, and may experience disabling fractures. Research has not shown whether drug treatments for the prevention of osteoporosis (such as zoledronic acid) could also prevent fractures for them. Researchers at Sutter’s San Francisco Coordinating Center (SFCC) designed the “Trial of Parkinson’s and Zoledronic Acid” (TOPAZ) study to answer that question.

Steve Cummings, MD
Steve Cummings, MD

“There are few treatments for Parkinson’s disease itself, but TOPAZ could show how a simple treatment given at home could prevent one of the most important causes of disability and death in these patients,” said Steve Cummings, M.D., director of SFCC and a lead investigator of TOPAZ.

Dr. Cummings noted that TOPAZ is the first study of its kind nationwide. The study aims to enroll 3,500 patients with Parkinson’s disease who are 65 years or older. As part of the study, neurologists who specialize in Parkinson’s disease may conduct a video interview with the patient to confirm the diagnosis.

A study nurse will check patients to confirm that treatment with zoledronic acid would be safe, and once confirmed, will then give zoledronic acid or placebo intravenously. Patients will be contacted every four months for at least two years about whether they have had a fracture.

SFCC leads the effort with a nationwide research team including neurologists and bone disease experts from UC San Francisco (UCSF), the Parkinson’s Foundation and Duke University.

“Fractures can result in a loss of independence, so it’s important to find ways to prevent them, particularly in this group of patients,” said Parkinson’s disease expert Caroline Tanner, M.D., Ph.D., professor of neurology at UCSF and a lead investigator of TOPAZ. “We hope this study will provide us with some answers.”

“Patients with Parkinson’s disease have difficulty traveling to clinics for care. Our goal is to test if we can bring the evaluation and treatment to their home making it easier for them to reduce their risk of disabling fractures,” added Kenneth W. Lyles, M.D., senior fellow in the Center for the Study of Aging and Human Development at Duke University, TOPAZ lead investigator at Duke, and world expert on zoledronic acid.

The five-year, $30 million study is sponsored by the National Institute on Aging, part of the U.S. National Institute of Health.

Nearly 800,000 Americans age 65 or older have Parkinson’s disease—a brain illness that causes slow loss of control of movements, walking and balance, increased risk of falling and decreased cognitive functions. There is no cure for Parkinson’s disease, but TOPAZ could show that one treatment could prevent a disabling consequence of the illness.

For patients:
For more information on TOPAZ and to enroll in the study, call 1-800-4PD-INFO (1-800-473-4636). You may be referred to UCSF to arrange a telemedicine neurology assessment at home to confirm that the study is right for you.

For Parkinson’s disease specialists:
Call 1-800-4PD-INFO (1-800-473-4636) for more information on enrolling patients directly into the trial.

Antibody Testing of Healthcare Workers May Show Spread of COVID-19

Posted on Jun 1, 2020 in California Pacific Medical Center, Innovation, Quality, Research, Safety, Scroll Images

antibody tests

A new study launching at Sutter’s California Pacific Medical Center (CPMC) will use antibody tests to identify front-line doctors who have developed antibodies against the virus. Antibody tests (also called “serology tests” because they use blood samples) are used to determine if someone is producing antibodies to defend against the virus.

“A powerful way to help limit the spread of COVID-19 is to facilitate early and accurate diagnoses of viral infections and appropriate quarantine for those infected,” says Greg Tranah, Ph.D., scientific director of CPMC’s Research Institute, director of Sutter’s Center for Precision Medicine Research, and lead researcher of the new physician serology study at CPMC.

Current methods diagnose COVID-19 are valid, but can have limitations when it comes to tracking disease patterns. Serology tests show some promise in this area, for use in certain circumstances.

“Serology tests may help identify people who have been exposed to the virus even weeks after an initial infection, including people who did not show symptoms. Other studies of COVID-19 ‘seropositivity’ can reveal the extent of viral exposure, as well as the timing of first exposure and increasing rates of exposure,” says Dr. Tranah.

The new serology study aims to enroll intensivists, emergency department doctors, infectious disease specialists, anesthesiologists, hospitalists, surgeons and internal medicine residents at CPMC.

Beginning May 18, blood samples will be collected from study participants every eight weeks through 2020. The samples will be tested for the presence of antibodies produced in response to prior COVID-19 exposure. Study participants will be asked to answer a brief questionnaire to determine if they have experienced symptoms of COVID-19.

“We’re using a two-step serology test that can process multiple samples concurrently with high reliability, sensitivity and specificity,”(1) says Jose Montoya, M.D., an infectious disease specialist working at Sutter’s Palo Alto Medical Foundation who is collaborating with Dr. Tranah on the study.

Serology tests with high sensitivity and specificity are less likely to have false-positive or false-negative results and a more meaningful predictive value.

Results of the blood tests will be stored in a database, and rates of seropositivity will be compared across medical specialties bi-monthly. “Longitudinal serology testing will allow us to track rates of seropositivity among different physician specialty groups and study the duration and intensity of immune response to COVID-19,” says Dr. Tranah.

There is no current evidence that people who have detectable antibodies are immune to re-infection from COVID-19 or what the timeframe of immunity is, if any. Until more evidence is available, antibody tests should not be used to make decisions related to social distancing or the use of personal protective equipment.

“Understanding the surge of infection rate and spread is an important part of preparedness. Epidemiological studies of emerging COVID-19 infections can help determine the burden of disease, develop better estimates of morbidity and mortality, and help complement the results of PCR tests,” says Dr. Tranah.

Learn more about COVID-19 tests by following our Educational Series on this topic.

Reference:

  1. Nirmidas Biotech Rapid Test for COVID-19 IgM/IgG.

Can a Long-acting, Injectable Drug Prevent HIV Infections?

Posted on May 31, 2020 in Alta Bates Summit Medical Center, Community Benefit, Expanding Access, Innovation, People, Quality, Research, Scroll Images

Christopher Hall, M.D., knows well the uncertainty and fear sparked by an infectious disease outbreak, as well as the excitement spurred by new research to develop effective treatment and vaccines.

An infectious disease specialist and researcher at Sutter’s Alta Bates Summit Medical Center (ABSMC) in Oakland, Dr. Hall began working to combat the HIV virus in 1987 in Washington, DC. Subsequent clinical leadership work at prominent HIV/AIDS care centers earned him the “street cred” to be selected for consulting roles for sexually transmitted infection (STI) prevention training programs, and membership among a national coalition of STI experts.

While the world awaits effective, safe treatments and a potential vaccine for COVID-19, HIV research has dramatically flashed forward since the AIDS epidemic of the 1980s. Among the biggest achievements in HIV prevention came in 2012, when the U.S. Food and Drug Administration (FDA) approved a daily pill called Truvada® as a means to prevent HIV virus infection—a strategy known as HIV pre-exposure prophylaxis (PrEP) for people who are HIV-negative.

Dr. Hall hopes his latest research initiative will have a similar significant impact. He leads Sutter’s participation at ABSMC in a clinical trial testing a new long-acting, injectable drug for the prevention of HIV. Earlier this month, preliminary results of an international study of the antiviral cabotegravir as PrEP were released by the HIV Prevention Trials Network (HPTN).(1,2) The results haven’t yet been published in a peer-reviewed journal.

The international, Phase 3 study known as HPTN 083 compares the effectiveness of bimonthly cabotegravir injections with oral Truvada® as PrEP to prevent HIV infection in people aged 18 years and older.

Chris Hall, M.D. and research coordinator Trish Smallwood

“This large-scale study is the first of its kind to show a long-acting form of HIV prevention to be highly effective,” says Dr. Hall. “Without a vaccine, the more options for PrEP that we can prove are effective and safe, and make accessible to people who may benefit, the better. Different options are needed for different patients. Cabotegravir injection may be an excellent tool to include in the PrEP toolkit, especially for people who have difficulty taking a daily oral medication as PrEP.”

HPTN 083—a four-year trial that began in 2016—is led by the National Institute of Allergy and Infectious Diseases (NIAID). The study randomized approximately 4,600 men and transgender women who have sex with men and are at high risk of contracting HIV, to receive either intramuscular injections with cabotegravir every two months, daily Truvada®, or placebo.(3)

Among the 50 people who became infected with HIV during course of the study, 12 were randomized to receive cabotegravir and 38 received daily Truvada®. Results showed that one third as many people became infected on cabotegravir compared with the oral drugs.

Though the study was designed to demonstrate that cabotegravir was at least as effective as conventional Truvada®, early results suggested the superiority of the injectable medication. With the encouraging results, an independent safety committee recommended the study stop early.

Conducting the study through ABSMC’s East Bay Advanced Care (EBAC) presented a unique opportunity to enroll participants from diverse, underserved communities in San Francisco’s East Bay area.(4) A commonly reported criticism of past HIV prevention research has been that the populations studied did not reflect the populations most affected.(5,6)

“We enrolled participants from San Francisco’s East Bay with the goal to study a patient population that closely reflects people at highest risk of HIV infection,” says Dr. Hall. Two-thirds of the participants were younger than 30 years old, 12% were transgender women, and 50% were African American.

“All three demographics are among the most vulnerable and at highest risk for acquiring HIV. And although specific enrollment of Latinos/Hispanics was not originally part of the study design, people from Hispanic communities were actively recruited and enrolled, and the study is stronger with their participation.”

Though results of the HPTN 083 study may be a coup for the international HIV/AIDS community, its added value in Northern California may lie in providing a new asset for EBAC: knowledge from medical research that may benefit people seeking care at the Center.

“At East Bay Advanced Care, we’re proud to offer hands-on support, medical treatments, complementary therapies and educational services for people living with HIV/AIDS,” says Jeff Burack, M.D., an internal medicine physician at Sutter and medical director of EBAC. “Insights from studying this promising new strategy for HIV prevention may greatly expand our ability to deliver care informed by science and guided by an ethos to support health equity.”

It is not yet known when single-agent cabotegravir will be reviewed for approval by the FDA for the prevention of HIV. A Viiv Healthcare press release stated that detailed results from HPTN 083 will be presented at an upcoming scientific meeting and used for regulatory submission to the FDA.

East Bay Advanced Care (EBAC): The largest HIV primary care clinic in the East Bay, EBAC delivers care and provides resources to approximately 1,400 people from diverse communities in the surrounding area.

The Center provides a comprehensive continuum of high-quality, professional treatment and support services to all clients regardless of their socioeconomic status. “Our mission is to provide essential, confidential medical and support services to all people living with HIV. The hope is to maximize quality and length of life, and to enhance personal dignity and self-empowerment in the face of HIV,” says Dr. Burack. Each year, an estimated 1.7 million people are newly diagnosed with HIV.(7) Interested in supporting research at EBAC? Donate to Alta Bates Summit Medical Center.

Targeting the HIV/AIDS virus—decades of research give new hope for “cure”: What does it take to halt a virus that has claimed the lives of approximately 32 million people?(7) HIV drugs cannot cure the disease, but they can help people with the virus stay healthy by preventing the virus from reproducing. The HIV virus completes several different steps to make copies of itself as part of the HIV lifecycle. If unimpeded, HIV integrates its viral DNA with the body’s healthy CD4 cells, essentially turning the CD4 cell into a factory that makes more HIV cells, resulting in an HIV infection. All HIV drugs work by interrupting a step in HIV’s lifecycle; this helps halt HIV replication.

Currently, six classes of HIV drugs target four steps of HIV’s lifecycle. Cabotegravir stops the HIV viral replication process at the crucial point of the virus attempting to integrate its DNA with the DNA of a healthy CD4 cell. “The approval of new classes of HIV drugs — and new drugs in the classes already available — will help provide more treatment options for people living with HIV,” says Dr. Hall.

References:

  1. Cabotegravir is manufactured by ViiV Healthcare.
  2. The HPTN 083 study that is part of the NIH-DAIDS-funded HIV Prevention Trials Network (HPTN). HTPN 083 was jointly funded by the U.S. NIAID, part of the NIH, and ViiV Healthcare, and was conducted by the HPTN. Study product was provided by ViiV Healthcare and Gilead Sciences.
  3. This particular group of study participants was selected because, in trials such as HPTN 083, demonstrating efficacy requires the population studied is at risk of acquiring HIV – otherwise, study endpoints cannot be reached in a reasonable amount of time.
  4. HPTN 083 was also offered to partners of existing patients as well as the clinic’s prevention program clients.
  5. A pandemic of the poor: social disadvantage and the U.S. HIV epidemic. Jennifer A. Pellowski, Seth C. Kalichman, Karen A. Matthews, and Nancy Adler. Am Psychol. 2013 May-Jun; 68(4): 197–209. doi: 10.1037/a0032694.
  6. HIV/AIDS Inequality: Structural Barriers to Prevention, Treatment, and Care in Communities of Color. Why We Need A Holistic Approach to Eliminate Racial Disparities in HIV/AIDS. Russell Robinson and Aisha C. Moodie-Mills. July 27, 2012.
  7. World Health Organization data. https://www.who.int/gho/hiv/en/