Practice Statements - Hepatitis B Vaccination, Screening, and Linkage to Care

Clinical Guidelines |5 December 2017
Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice From the American College of Physicians and the Centers for Disease Control and Prevention
Winston E. Abara, MD, PhD; Amir Qaseem, MD, PhD, MHA; Sarah Schillie, MD, MPH, MBA; Brian J. McMahon, MD; Aaron M. Harris, MD, MPH (*); for the High Value Care Task Force of the American College of Physicians and the Centers for Disease Control and Prevention

FULL ARTICLE

Abstract

Background:
Vaccination, screening, and linkage to care can reduce the burden of chronic hepatitis B virus (HBV) infection. However, recommendations vary among organizations, and their implementation has been suboptimal. The American College of Physicians' High Value Care Task Force and the Centers for Disease Control and Prevention developed this article to present best practice statements for hepatitis B vaccination, screening, and linkage to care.

Methods:
A narrative literature review of clinical guidelines, systematic reviews, randomized trials, and intervention studies on hepatitis B vaccination, screening, and linkage to care published between January 2005 and June 2017 was conducted.

Best Practice Advice 1:
Clinicians should vaccinate against hepatitis B virus (HBV) in all unvaccinated adults (including pregnant women) at risk for infection due to sexual, percutaneous, or mucosal exposure; health care and public safety workers at risk for blood exposure; adults with chronic liver disease, end-stage renal disease (including hemodialysis patients), or HIV infection; travelers to HBV-endemic regions; and adults seeking protection from HBV infection.

Best Practice Advice 2:
Clinicians should screen (hepatitis B surface antigen, antibody to hepatitis B core antigen, and antibody to hepatitis B surface antigen) for HBV in high-risk persons, including persons born in countries with 2% or higher HBV prevalence, men who have sex with men, persons who inject drugs, HIV-positive persons, household and sexual contacts of HBV-infected persons, persons requiring immunosuppressive therapy, persons with end-stage renal disease (including hemodialysis patients), blood and tissue donors, persons infected with hepatitis C virus, persons with elevated alanine aminotransferase levels (≥19 IU/L for women and ≥30 IU/L for men), incarcerated persons, pregnant women, and infants born to HBV-infected mothers.

Best Practice Advice 3:
Clinicians should provide or refer all patients identified with HBV (HBsAg-positive) for posttest counseling and hepatitis B–directed care.

Continue reading: http://annals.org/aim/fullarticle/2664089/hepatitis-b-vaccination-screening-linkage-care-best-practice-advice-from

Behind the Headlines - Some type 1 diabetes cases in adults misdiagnosed as type 2

What is Behind the Headlines?
Each day the NHS Choices team selects health stories that are making headlines. These, along with the scientific articles behind the stories, are sent to Bazian, a leading provider of evidence-based healthcare information. Bazian's clinicians and scientists analyse the research and produce impartial evidence-based assessments, which are edited and published by NHS Choices. The following article was published December 1, 2017; analysis by Bazian and edited by NHS Choices.

Some type 1 diabetes cases in adults misdiagnosed as type 2 

Friday December 1 2017

“Doctors 'wrong to assume type 1 diabetes is childhood illness',” says The Guardian.

This follows a study looking at a large number of adults in the UK to see if they had diabetes and if so, which type of the condition they had.

Type 1 diabetes is an autoimmune condition where the body destroys the insulin-producing cells of the pancreas, so is reliant on life-long insulin injections. Type 2 diabetes is a condition where the person produces limited insulin, or their body can't use it so well. It can be managed in the early stages with changes to diet and medication.

Type 1 diabetes is often thought of as a “childhood illness” as most people are diagnosed at a young age. For this reason, people who develop diabetes as adults are often assumed to have type 2. Perhaps the most famous example is Prime Minister Theresa May who was, at first, misdiagnosed with type 2 diabetes in 2013, when in fact further tests revealed she had type 1.

This study looked at 13,250 people diagnosed with diabetes at a range of ages. Of all people who developed type 1 diabetes, surprisingly 42% were not diagnosed until after the age of 30.

However, only 4% of all newly diagnosed diabetes in the over 30s were type 1. Therefore, although type 1 diabetes starting in adulthood is uncommon, it still highlights the need for healthcare professionals to be aware that not all people who develop diabetes in adulthood automatically have type 2.

Making sure that people receive the correct diagnosis, and therefore the correct treatment, is crucial.

If you have been diagnosed with type 2 diabetes but are not responding to treatment, it may be worth discussing the possibility of further testing with your doctor.

Where did the story come from?
The study was carried out by researchers from the University of Exeter using data from a nationwide study called UK Biobank. It was funded by The Wellcome Trust and Diabetes UK. It was published in the peer-reviewed medical journal The Lancet: Diabetes and Endocrinology.

The story was covered by the BBC and The Guardian, both of which accurately covered the key findings and explained the importance of receiving a correct diagnosis to ensure people are given the right treatments.

What kind of research was this? 
This researchers used data from a large, ongoing cohort study called UK Biobank which started in 2006. The study aimed to see how people with genes predisposing them to type 1 diabetes developed the condition in later life rather than in childhood or teenage years as usual.

UK Biobank involves more than half a million adults across the country, and has followed them up for a number of years. As well as attending health screening sessions, participants have also given blood samples from which genetic information can be recorded. For this research, a snapshot was taken of people from UK Biobank who were of white European descent, and who had genetic data available.

A cohort study that followed people from childhood throughout their lives may have been able to look at this in more detail. But the size and coverage of the UK Biobank study make this a useful starting point to look at whether people with genetic risk factors for type 1 diabetes are diagnosed in adulthood or childhood.

What did the research involve? 
The study involved a sample of 379,511 people from the UK Biobank study, of whom a subgroup had diabetes. All were of white European background and had genetic data available. None of the people were related to each other.

The researchers assessed all people for genetic variants known to be associated with type 1 diabetes. They then gave each person a genetic risk score for their risk of developing type 1 diabetes.

Self-reports of a diabetes diagnosis were assessed by questionnaire at study enrolment or later follow-up. People provided information about the age they received a diagnosis, and whether they used insulin within one year of diagnosis (reliance on insulin would indicate type 1). They also reported any hospital admissions for diabetic ketoacidosis (a serious complication of diabetes), and general health such as body mass index.

For the analysis, the researchers compared people with ‘high risk’ or ‘low risk’ for type 1 diabetes based on the results of the risk score. They limited analysis to cases of type 1 or type 2 diabetes occurring in people aged 60 or under at time of diagnosis, as after that point any new cases are almost certain to be type 2 diabetes.

What were the basic results? 
In the study sample there were 13,250 people with diabetes, 55% of whom had high genetic risk scores and the remainder had low risk scores.

There were 1,286 cases (9.7%) of type 1 diabetes, and all of these occurred in people with the high risk score:
18% of those with a high risk score were diagnosed with type 1 diabetes, the remainder with type 2
42% of those in the high risk group diagnosed with type 1 (537) were diagnosed between the ages of 31 and 60, with the remainder diagnosed under the age of 30 (as is more usual)
of all people aged under 30 at time of diabetes diagnosis (all risk categories), 74% had type 1 diabetes
of all people aged 31 to 60 at time of diabetes diagnosis, 4% had type 1 diabetes
across all ages of life, people with a high genetic risk score were more likely to be diagnosed with any type of diabetes than people with a low risk score

All people diagnosed with type 1 after the age of 30 needed insulin treatment, compared to only 16% of people diagnosed with type 2 (who started insulin later, after 7 years on average). They also had a lower body mass index (BMI) than those with type 2.

How did the researchers interpret the results?
The researchers stated their findings have “clear clinical implications”, alerting healthcare professionals to the fact that type 1 diabetes can occur in the over-30s. They recommend that recognition of late-onset type 1 diabetes is an important area of improvement for both medicine and research.

Conclusion 
This study gives us an important insight into the way in which type 1 diabetes has been mislabelled as a “childhood condition”. It suggests that a number of people with genetic risk factors are also diagnosed in midlife, when most new diabetes diagnoses would be thought to be type 2.

However, there are a few points to note:
The study shows that of all people diagnosed with diabetes after age 30, the vast majority (96%) were still type 2 diagnoses. Therefore, though practitioners need to be aware, this only accounts for a small proportion of all diagnoses.

Even among people with hereditary risk factors for type 1 diabetes, most diagnoses were still type 2.
The diagnosis of diabetes was based on people's own reports, rather than looking at medical records.

People are unlikely to be wrong about whether they have the condition or not, but there may be some uncertainty as to whether they self-reported the correct type, age at which they were diagnosed, or when they started insulin.

The study only looked at people from a white European background. Type 1 and type 2 diabetes prevalence and risk factors may differ in people from other ethnic backgrounds, so this study’s results cannot be generalised to everyone.

When the UK Biobank study started in 2006, the majority of people taking part were aged 40 or over. This means that they were children in the 1980s or earlier. Since that time, the diagnosis of diabetes may have improved. It would also mean that people who suffered complications from the disease and died in earlier life would not have been included.

The study can't tell us how many of these people with type 1 in later life may have been misdiagnosed initially, or had insulin treatment delayed when they needed this to start with.

People who commit to take part in studies like UK Biobank might be more active about monitoring and managing their health than people in the general population. Therefore people in this study may have had slightly different experiences when getting diagnoses, or have different lifestyle behaviours that could affect their risk of conditions like diabetes.

Nonetheless, this study highlights the fact that type 1 diabetes can begin in adulthood as well as in childhood. Adults diagnosed with diabetes must receive the correct diagnosis to get the right treatment as soon as possible. If you are concerned that you may have been misdiagnosed, ask the doctor in charge of your care for advice.

Link
https://www.nhs.uk/news/diabetes/some-type-1-diabetes-cases-adults-misdiagnosed-type-2/

Colorado lifts restrictions for treating hepatitis C patients; no longer need to have advanced liver damage to receive drugs

Colorado lifts restrictions for treating hepatitis C patients; no longer need to have advanced liver damage to receive drugs

By Jennifer Brown |The Denver Post
December 1, 2017 at 6:43 pm

Friday’s decision by the state Medicaid department comes in the midst of a class-action lawsuit filed by the American Civil Liberties Union of Colorado and after top health officials asked the department to lift restrictions that determined which patients could receive life-altering treatment.

It also comes as the price of the antiviral drugs — which cure up to 90 percent of patients — has dropped from $84,000 per treatment to about $14,000.

Continue reading: http://www.denverpost.com/2017/12/01/colorado-hepatitis-c-medicaid-patients-can-receive-antiviral-drugs/

Mavyret: A Pan-Genotypic Combination Therapy for the Treatment of Hepatitis C Infection

Published as part of the Biochemistry series “Biochemistry to Bedside”
Department of Biochemistry and Molecular Pharmacology, University of Massachusetts Medical School, Worcester, Massachusetts 01605, United States
DOI: 10.1021/acs.biochem.7b01160
Publication Date (Web): December 1, 2017
Copyright © 2017 American Chemical Society

Viewpoint
Mavyret: A Pan-Genotypic Combination Therapy for the Treatment of Hepatitis C Infection
Ashley N. Matthew, Nese Kurt Yilmaz, and Celia A. Schiffer

Hepatitis C virus (HCV), a virus that infects more than 180 million people worldwide, is the causative agent of chronic liver disease, which often progresses to fibrosis, liver cirrhosis, and hepatocellular carcinoma (HCC). According to the World Health Organization, almost half a million patients infected with HCV die each year from cirrhosis and HCC alone. In the last several years, treatment of HCV infections has been revolutionized by the development of small molecular inhibitors that target essential proteins encoded by the viral genome. These inhibitors, known as direct-acting antivirals (DAAs), have improved treatment option and outcomes and eliminated the need for interferon injections. However, the emergence of resistance-associated variants (RAVs) and high genetic variation among the six distinct genotypes of the virus have been presenting challenges, even leading to treatment failure.

Newer all-oral DAA combination regimens for HCV infection consist of inhibitors that target the NS3/4A, NS5A, and NS5B viral proteins. Of note, NS3/4A protease inhibitors have become a mainstay of treatment as most new therapies contain an inhibitor from this class. While highly effective against other genotypes, treatment of genotype 3 infections has been the most challenging, especially in patients who failed previous therapy or have cirrhosis. Recently, AbbVie received Food and Drug Administration (FDA) approval for one of the first pan-genotypic combination therapies, Mavyret, consisting of glecaprevir and pibrentasvir, an NS3/4A protease and an NS5A inhibitor, respectively (Figure 1). Given the excellent pan-genotypic response and safety profile in patients, Mavyret was approved for the treatment of genotypes 1–6 in patients without cirrhosis, or with compensated cirrhosis. In patients with non-cirrhotic chronic HCV who were treatment-naïve or had previously been treated with pegylated interferon or ribavirin, the sustained virological response (SVR) rate was 83–100% across all genotypes.(1) In treatment-naïve patients with compensated liver disease, 99% of patients achieved SVR with a 12-week course.(2) Mavyret was approved as an 8-week course for treatment-naïve patients without cirrhosis, shortening the previous standard of care by an additional 4 weeks.

One component of the Mavyret combination, pibrentasvir (ABT-530), has excellent potency across all HCV genotypes and retains potency against common RAVs. Pibrentasvir had EC50 values across genotypes ranging from 1.4 to 5 pM against the HCV replicon in antiviral assays.(3) Under the selective pressure of inhibitors, RAVs emerge at positions 28, 30, 31, and 93 in the NS5A protein. In fact, all current NS5A inhibitors are susceptible to mutations at Tyr93. In vitro studies indicate pibrentasvir also selects these mutations, including Y93H, that confer resistance to other NS5A inhibitors.(3) However, pibrentasvir maintained good potency against many single-site NS5A mutations, suggesting double or triple mutants need to emerge to confer high levels of resistance against this inhibitor.

The other component of Mavyret, glecaprevir (ABT-493), is a P2–P4 macrocyclic NS3/4A protease inhibitor with subnanomolar to low nanomolar activity against all genotypes, including genotype 3.(4) NS3/4A protease inhibitors are often susceptible to single-site mutations at residues Arg155, Ala156, and Asp168. Most if not all protease inhibitors are susceptible to mutations at Asp168, which are often present in patients who fail therapy with a protease inhibitor. Notably, this active site residue is not conserved in genotype 3 and is Gln168 instead, contributing to the natural resistance of genotype 3 to most treatments. While potent against 168 variations, including genotype 3, glecaprevir is highly susceptible to A156T and A156V mutations. We have shown that inhibitors containing P2–P4 macrocycles, as in glecaprevir, are susceptible to changes at Ala156, as substitutions with a larger side chain result in steric clash with the inhibitor’s macrocycle.(5) Luckily, mutations at Ala156 do not occur alone because of reduced replicative capacity; however, additional mutations could restore the enzymatic fitness, which can lead to clinically viable multi-mutant resistant variants.

Thus, both components of Mavyret have good resistance profiles against wild type genotypes and single-mutant variants of HCV. What needs to be considered is the emergence of double, triple, or other multi-mutant variants that may have high levels of resistance to one or both components of this combination. Such multi-mutant variants potentially pose a threat to the longevity and success of HCV treatment. There are already double- and triple-mutant variants that have been isolated from patients who failed therapy with previously FDA-approved combination therapies. Considering the similarity in the inhibitor scaffolds and modes of action, there is a danger that these variants may be cross-drug resistant and not respond to any current treatment option, including Mavyret. As new drugs and combinations are developed, it will be important to understand the mechanisms of resistance for these multi-mutant variants and incorporate those insights into drug design. Rather than concentrating all effort into inhibitors from the same class with highly similar scaffolds, diversifying the arsenal of DAAs and considering triple-combination therapy may be required to avoid cases of incurable HCV infection.

The approval of Mavyret dual-combination therapy marks another milestone in the treatment of HCV infections. There had been a major effort to develop an all-oral combination therapy with activity against all genotypes. With the approval of Mavyret, this goal has been met. The newer-generation inhibitors and various combinations provide treatment options for patients and improve SVR rates across all genotypes. For many cases, Mavyret has decreased the standard of care from 24 to 8 weeks. More importantly, treatment options for patients with compensated liver disease are now available. One major remaining concern is the possible emergence of drug resistance. The newer inhibitors have better activity against single-site RAVs, but highly resistant multi-mutant strains may become clinically relevant. Preventing the emergence and spread of cross-resistant variants and developing inhibitors with improved potency against such variants may be the next challenge.

References

Full Text

http://pubs.acs.org/doi/full/10.1021/acs.biochem.7b01160

Which group/groups of HCV-infected individuals are at highest risk for all-cause mortality resulting from HCV?

Infectious Disease Advisor

Racial Disparities in HCV Incidence and Treatment Outcomes

Jasenka Piljac Žegarac, PhD

December 01, 2017

In an interview with Infectious Disease Advisor, Elana Rosenthal, MD, assistant professor of medicine at the Institute of Human Virology, University of Maryland School of Medicine in Baltimore, and Paul H. Naylor, PhD, adjunct associate professor at the Department of Internal Medicine/Gastroenterology, Wayne State University School of Medicine in Detroit, Michigan, discussed the latest insights on racial disparities in HCV incidence and treatment outcomes.

Infectious Disease Advisor: According to research to date, which group or groups of HCV-infected individuals are at highest risk for all-cause mortality resulting from HCV?

Dr Rosenthal: A recent study evaluated National Health and Nutrition Examination Survey data through 2011 and identified that Mexican-Americans with HCV had a significantly higher all-cause mortality compared with non-Hispanic blacks and non-Hispanic whites.3 It was postulated that this disparity may be related to higher risk for hepatocellular carcinoma in this population, or higher rates of lack of insurance. This highlights an important point: that in the era of direct-acting antivirals, the biggest risk for mortality lies in the inability to access curative therapy. In the United States, marginalized populations such as people who use drugs, incarcerated individuals, patients with limited insurance coverage, or those without medical insurance are most likely to suffer long-term consequences of hepatitis C, because they are the least likely to access HCV treatment.

Continue reading: http://www.infectiousdiseaseadvisor.com/hepatitis/hcv-racial-disparities-treatment-outcomes/article/711306/

Summary from AASLD 2017 for Hepatitis C HCV: Game over?

Conference Reports from NATAP

Summary from AASLD 2017 for Hepatitis C HCV: Game over?
Jurgen K. Rockstroh M.D., Professor of Medicine
Department of Medicine I, University Hospital Bonn, Bonn, Germany

Introduction
The AASLD Liver Meeting was held in October from 20-24th, 2017 in Washington DC, USA. Many regular AASLD attendees will still remember the completely packed late breaker sessions from recent years, full of phase II and III new direct acting antiviral (DAA) combination trials in varying patient populations. At this year AASLD Liver Meeting, no new DAA combination study results were presented in these sessions but rather were replaced by new drug trials for treatment of NASH or primary sclerosing cholangitis. Indeed, the only two new dual and triple DAA combinations, which were presented at the meeting, were accompanied by press releases from the respective companies Merck and Janssen, which announced the termination of their DAA development programs (1-2). Nevertheless, important new findings from the HCV research space were reported including issues around HCV screening, how to improve linkage to care, and treatment results from many different patient populations and real-life cohorts as well as post HCV cure monitoring. Reassuringly, the high success rates of all oral DAA therapy was further confirmed from a wealth of data particularly from somewhat more challenging HCV patient populations including: PWIDs, patients with concomitant advanced kidney disease, patients before and after kidney or liver transplantation, HCV genotype 3 infection and patients with unfavorable HCV disease characteristics, including compensated and decompensated cirrhosis (3-11). However, there was also data on shorter treatment durations for patients with more favorable HCV disease characteristics such as for non-cirrhotic GT1b patients (12). In addition, there was also new data around retreatment of previous DAA failures (with documented resistance development) with new DAA combinations (13-14). In the area of HIV-coinfection, clearly outcomes of the ACTG trial on treatment of acute hepatitis C in HIV-seropositive individuals for eight weeks with ledipasvir/sofosbuvir (LDV/SOF) were also new and noteworthy (15). Of interest were also reports on the increases in acute HCV infections among HIV-seropositive men who have sex with men (MSM) and the high risk of reinfection in particular patient populations (16-17). Further data was also presented on the question whether there is an increased risk for hepatocellular carcinoma in DAA treated patients from large real-life cohorts and what impact SVR has on clinical endpoints under continued follow-up (18-22).

The following AASLD summary report tries to capture the major new findings and results presented around the topics raised above, as well as to outline some of the status reports of HCV treatment implementation on a global level. Clearly, the successes of modern HCV DAA combination therapy still have not reached all in need for these treatments.

Continue reading... http://www.natap.org/2017/AASLD/AASLD_148.htm

NIH Statement on World AIDS Day 2017

NIH Statement on World AIDS Day 2017

After 30 years of marking progress against HIV, we are closer than ever to the beginning of the end of the HIV/AIDS pandemic.

Anthony S. Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases Maureen M. Goodenow, Ph.D., Director, Office of AIDS Research

Today marks the 30th celebration of World AIDS Day. Three decades ago, the HIV/AIDS pandemic looked very different than it does today. While AIDS had been part of our lives since 1981, the tools to fight the disease during that period were still inadequate, despite robust research efforts. Although the licensure in 1987 of AZT — the first antiretroviral medication to treat HIV — had been an important development, it soon became clear that the drug had only a limited and transient benefit. Prevention options were limited to basic “low-tech” tools such as condom use, needle exchange and behavioral modification. However, it was clear that we needed to do better.

Over the subsequent years, through an accelerated research effort, scientists created an array of new antiretroviral treatments that targeted several vulnerable functions in the replication cycle of the virus. When used in combinations, these drugs durably suppressed the replication of the virus. Over the years, drug regimens became even more powerful with fewer side effects. Today, therapies can allow a person living with HIV to achieve a nearly normal lifespan, and some regimens require only one pill once a day. In addition, landmark studies of antiretrovirals in pregnant women living with HIV showed that these drugs can prevent perinatal transmission of the virus.

Antiretrovirals have the capability of both treating HIV infection in an individual and preventing the transmission of the virus to another. Numerous studies have demonstrated that when a person living with HIV uses antiretroviral therapy to achieve and maintain a durably undetectable level of virus, he or she has effectively no risk of sexually transmitting HIV. For HIV-negative people, taking a single pill daily as pre-exposure prophylaxis, or PrEP, can reduce the risk of acquiring HIV by more than 90 percent. Emergency post-exposure prophylaxis, or PEP, can prevent HIV from establishing itself in the body if begun within three days of exposure and taken for an additional 28 days.

We have seen how lifesaving antiretroviral treatment can change the course of HIV disease in individual patients. It also can change the trajectory of the epidemic in communities, particularly when combined with other advances in HIV prevention. We see this change in communities that are precisely applying these interventions to dramatically decrease the incidence of new infections. A study published recently in the New England Journal of Medicine found that HIV incidence dropped by 42 percent among nearly 18,000 people in a Ugandan district during a 7-year period when the rates of HIV treatment and voluntary medical male circumcision were significantly increased.

If our current arsenal of treatment and prevention tools could be widely implemented, an end to the HIV/AIDS pandemic theoretically would be feasible. Realistically, however, we will need new and improved tools for our HIV treatment and prevention armamentarium along with implementation of new and existing approaches to end the HIV pandemic as we know it.

Adherence to once-daily therapeutics and PrEP can be challenging, and so researchers are investigating longer-acting formulations of these products that some people may find easier to use. A trial testing long-acting injectable cabotegravir for PrEP in women has launched in southern Africa, and the same drug currently is under investigation for men. Additional injectable and implantable formulations are in the research “pipeline,” providing hope that prevention and treatment could be delivered as infrequently as quarterly or even twice a year.

Other studies are testing the passive transfer of broadly neutralizing antibodies for preventing HIV infection. The results of these studies will inform HIV prevention and vaccine efforts. Earlier this year, NIAID’s Vaccine Research Center, together with partners from Sanofi, developed a novel, three-pronged antibody that protected against HIV-like infections in preclinical studies and is moving into clinical testing. Harnessing the power of antibodies holds great promise for developing new long-acting HIV prevention and treatment tools.

The ultimate goal for HIV prevention is development of a safe and effective vaccine. The National Institutes of Health announced yesterday that a new Phase 2b, proof-of-concept trial of an HIV vaccine has been launched in southern Africa. The study, called Imbokodo (HVTN 705), aims to enroll 2,600 HIV-negative women in sub-Saharan Africa. This new trial joins HVTN 702, a Phase 2b/3 vaccine efficacy trial being conducted in South Africa, aiming to build on the modest results of the RV144 vaccine trial in Thailand.

As the HIV prevention and treatment “toolkits” have matured, NIH has taken steps to ensure that all people can benefit from these advances. Transgender women — people whose birth certificates indicate or once indicated male sex but who identify as women — are at high risk of HIV infection, and are a key population for HIV prevention and treatment efforts. A recent study of transgender women living with HIV in Los Angeles found a majority were concerned about drug interactions when taking both antiretroviral therapy and feminizing hormone therapy. Little is known about this issue, and NIH is working to fill these knowledge gaps.

Pregnancy and infancy pose unique challenges to preventing HIV transmission and maintaining health. While safe and effective antiretroviral regimens have been developed for preventing perinatal transmission, further studies need to be performed to ensure that pregnant women and their infants can safely use newer forms of these medications. NIH plans to soon launch a large international study to compare the safety and efficacy of three antiretroviral treatment regimens for pregnant women living with HIV and to determine the safety of these regimens for their infants. This week, the U.S. Food and Drug Administration extended its approval (link is external) for the integrase inhibitor raltegravir for younger infants based on data from the NIAID-funded IMPAACT P1110 study. The drug is now approved for use in infants at birth.

After 30 years of marking progress against HIV with the observance of World AIDS Day, we are closer than ever to the beginning of the end of the HIV/AIDS pandemic. Science has delivered numerous tools and holds promise for additional options, yet implementation of these tools remains paramount. We must increase our efforts to deliver effective treatment and prevention strategies to those who need them. We thank and applaud the many clinical trial participants, researchers, health care professionals, advocates and others who are working to prevent new infections and improve the health of those living with HIV worldwide. We look forward to working across NIH with all the Institutes and Centers engaged in HIV and related research to ensure that scientific progress against the pandemic is maximized and that we do not lose what we have gained.

Media inquiries can be directed to the NIAID Office of Communications at 301-402-1663, niaidnews@niaid.nih.gov (link sends e-mail).

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

The Office of AIDS Research (OAR) coordinates the NIH HIV research investment across all 27 Institutes and Centers. More information on OAR is available on the OAR website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Treating The New Hep C Generation On Their Turf

Treating The New Hep C Generation On Their Turf

By Pauline Bartolone

December 1, 2017

The opioid addiction crisis has engendered an unfortunate side effect — an epidemic of new hepatitis C infections, mainly among young people who share infected needles. Although people over age 52 still account for the largest share of chronic hepatitis C cases, the highest number of new infections occurs among people in their 20s.

“We ask for people to think beyond that baby boomer box,” Bauer said. Public health organizations “can take their services on the road, so to speak, and they can make an extra effort to reach populations that may be more at risk.”

Continue reading: https://californiahealthline.org/news/treating-the-new-hep-c-generation-on-their-turf/