IDSA News - December 2017
(Print All Articles)

CMS Updates: Diagnostics Reimbursement Cuts, Medicare Physician Fee Schedule, QPP & ID

The Centers for Medicare and Medicaid Services (CMS) has released its final rate determinations for Medicare reimbursement for diagnostic tests. Most infectious diseases (ID) diagnostic tests will get a ten percent reduction in 2018, with a possibility of additional ten percent reductions over the next two years (for a total 30% reduction by 2020).

Cuts to ID Diagnostic Reimbursement Set to Take Effect

The Centers for Medicare and Medicaid Services (CMS) has released its final rate determinations for Medicare reimbursement for diagnostic tests. Most infectious diseases (ID) diagnostic tests will get a ten percent reduction in 2018, with a possibility of additional ten percent reductions over the next two years (for a total 30% reduction by 2020). The rates are scheduled to take effect on January 1, 2018. IDSA and other physician organizations remain concerned that the myriad issues with CMS’ approach to data collection led to inappropriate new reimbursement rates for many tests, which will subsequently reduce patient access to testing.

IDSA continues to work with the American Medical Association (AMA) and other laboratorian- and clinician-focused organizations to educate Congress on the likely negative impacts of decreased reimbursement on patient care, public health and diagnostics innovation. To help support our advocacy efforts, take our quick online survey or email jlevy@idsociety.org to share how your patients/research/institutions will be effected by the Clinical Laboratory Fee Schedule (CLFS) payment system. Specific examples of how decreased reimbursement may harm your patients will help us advocate for more appropriate reimbursement.

The agency also reported that it is working on an application that labs can use to classify their tests as advanced laboratory diagnostic tests, which are priced every year, or clinical diagnostic lab tests, which are priced every three years. The public has until January 17, 2018 to request reconsideration of gapfill (used when no comparable test is available) or crosswalk (used when a new test is clinically or technologically similar to existing tests) payments for new or substantially revised test codes. The public may then comment on these reconsideration requests at the next CMS Annual Laboratory Public Meeting in August.

CMS Releases the Final Rule for the 2018 Medicare Physician Fee Schedule

CMS recently released the Medicare Physician Fee Schedule Final Rule for 2018. Of note, the agency responded to comments on how the it should proceed with possible revisions of the evaluation and management (E/M) guidelines.

The current E/M guidelines were developed over 20 years ago and in that time the complexity of patients’ illnesses and comorbidities, as well as the practice of medicine has changed considerably. In our comments (PDF) to the agency, IDSA requested that CMS focus not only on revising the guidelines pertaining to the patient history and physician exam, but to take a more holistic approach to the revision of all components of an E/M visit including medical decision making, history, and the physical exam. CMS continues to defer on conducting an extensive research project that would revise and revalue the entire E/M code set. IDSA will continue to press the agency to conduct this research.

CMS finalized patient relationship modifiers that physicians will use to indicate the type of relationship a physician has with a patient during a specific episode of care. The modifiers are not mandatory at present, but it is expected that the use of the modifiers will become mandatory in the coming years. As of January 1, 2018, physicians may voluntarily report the modifiers as means to become familiar with their use. IDSA noted in our comments to CMS that we consider the modifiers another layer of administrative burden while adding nothing to the improvement of patient care. The modifiers are as follows:

Patient Relationship Modifiers
X1 Continuous/broad service
X2 Continuous/focused services
X3 Episodic/broad services
X4 Episodic/focused services
X5 Only as ordered by another clinician

Quality Performance Improvement: Implications for the ID Clinician

2018 Quality Payment Program Final Rule Comments

CMS has released the final rule with comment period for the 2018 Quality Payment Program (QPP). The 2018 QPP final rule establishes the requirements clinicians must meet to receive Medicare reimbursements. IDSA continues to advocate on behalf of the IDSA membership regarding issues that may impact the satisfactory participation of ID physicians in the QPP. In brief, IDSA has submitted the following comments to CMS regarding the 2018 QPP final rule.

Cross-cutting Measures: Historically, CMS physician quality payment incentive programs have required clinicians to report on quality measures that are broadly applicable to all clinicians regardless of the clinician’s specialty, also known as “cross-cutting measures.” For example, a patient screened for high blood pressure with a documented recommended follow-up care plan is a designated cross-cutting measure. In the 2018 QPP final rule, CMS has not finalized the policy of requiring clinicians to report cross-cutting measures. IDSA provided comments stating our belief that this requirement would be overly burdensome and promotes overutilization as it does not leverage the expertise of a specialist when treating a patient.

Topped Out Measures: CMS defines a quality measure as “topped out” if the measure’s performance rate is consistently high such that meaningful performance improvement cannot be distinguished amongst clinicians. With this definition of topped out, two of the five quality measures most reported by ID physicians in previous CMS physician quality payment incentive programs will be phased out over a four-year period. IDSA has expressed serious concern with this as the options of clinically relevant quality measures to appropriately measure the performance of an ID physician is nearly nonexistent and this prospective removal of the two measures would detrimentally effect ID physician reporting.

Infectious Diseases Measure Set: CMS has made available specialty measure sets that should be used as a guide for clinicians to choose measures applicable to their specialty. In the 2018 QPP final rule, CMS has finalized the Infectious Disease Specialty Measure Set in Table B. 29. IDSA has stated our strong reservations regarding the clinical relevancy of many of the measures outlined in this set. Furthermore, IDSA urged CMS to revise the measure set to include four measures that better align with the practice and reporting patterns of an ID physician.

Please visit IDSA’s Access and Reimbursement for ID Services page for past comment letters.

List of Measures under Consideration for Medicare Programs (MUC)

Annually, CMS is mandated to release a list of quality measures for consideration, known as the MUC List, for adoption through rulemaking for Medicare quality payment incentive programs such as the Merit-based Incentive Payment System (MIPS), which is one of two possible clinician participation tracks for the Quality Payment Program (QPP), and the Hospital Inpatient Quality Reporting Program. IDSA has provided comments to the MUC List for 2017 (PDF), specifically regarding a proposed quality measure related to shingles vaccination, MUC17-310 Zoster (Shingles) Vaccination. We stated our full support of the evidence and rationale for this measure to be adopted into Medicare quality programs but had concerns regarding the Medicare coverage for the shingles vaccine. Medicare does not reimburse physicians for administering the shingles vaccination. Additionally, the measure is unclear whether a physician would be required to vaccinate a patient who has no documentation for being vaccinated for shingles. For more information regarding the MUC List and the rulemaking process for measure selection for Medicare quality payment programs, please visit CMS’ Pre-rulemaking page.

Federal Funding Update

Congress approved a second Continuing Resolution in early December to keep the federal government running through December 22. This buys lawmakers more time to come up with a bipartisan budget agreement that averts across the board sequestration cuts and ensures increased spending caps that Congress must have in order to pass a separate FY2018 funding bill for all federal programs.

Congress approved a second Continuing Resolution in early December to keep the federal government running through December 22. This buys lawmakers more time to come up with a bipartisan budget agreement that averts across the board sequestration cuts and ensures increased spending caps that Congress must have in order to pass a separate FY2018 funding bill for all federal programs.

IDSA and HIVMA will continue to fight for deeper investments in federal ID and HIV program funding at the National Institutes of Health, Centers for Disease Control and Prevention, Health Resources and Services Administration, U.S. Agency for International Development, and the State Department, for the rest of this year and beyond. Congress needs to hear from their constituents about the importance of ID/HIV funding and we encourage you to add your voice to our collective efforts.

A third Continuing Resolution through December 30 is expected, to which Congress may attach the overdue renewal of the Children’s Health Insurance Program (CHIP), which provides healthcare coverage to 8.9 million children. Alternatively, reauthorization of the program may come at the expense of the much-needed Prevention and Public Health Fund (PPHF). House-passed legislation would reauthorize CHIP and other valuable programs including the Community Health Centers program and the National Health Service Corps by using 75 percent of funding from the PPHF. The PPHF provides more than 12 percent of the CDC’s funding, and essential support for the Section 317 immunization Program, epidemiology and laboratory capacity efforts, and activities to address healthcare associated infections. Preserving the PPHF is critical to fighting infectious diseases and we will continue to advocate in support of the Fund.

IDSA is also following the Trump Administration’s third hurricane supplemental funding proposal, which was recently submitted to Congress, as we continue to advocate for additional resources to address areas hard-hit by Hurricanes Harvey, Irma, and Maria, particularly in Puerto Rico and the U.S. Virgin Islands.

HHS Tick-borne Disease Working Group

IDSA President Paul Auwaerter, MD, FIDSA gave an invited presentation at the first meeting of the U.S. Department of Health and Human Services Tick-borne Disease Working Group this month in Washington, DC. This Working Group was created by the 21st Century Cures legislation to review current federal government efforts to combat tick-borne diseases, promote interagency collaboration, identify gaps in federal activities, and make recommendations.

Lyme disease advocates were strong proponents of this working group and are well represented on the panel. The meeting included presentations from several Lyme disease patient groups as well as public comment from many individual patients who have had significant medical issues.

Dr. Auwaerter’s presentation recommended greater federal investment in surveillance and prevention efforts (including development and utilization of a Lyme vaccine), improved diagnostics, and research to guide optimal interventions. Dr. Auwaerter spoke to key controversies regarding Lyme disease and treatment from an evidence-based foundation.

The Working Group has developed six subcommittees to focus on: surveillance, diagnostics, treatment, research, non-Lyme tick-borne diseases, and access to care. IDSA plans to recommend experts from our membership to serve on some of these subcommittees. The Working Group hopes to find areas of common ground among the various stakeholders and to develop report with recommendations by December of next year.

WHO Declares Commitment to End TB by 2030

IDSA Participates in Global Conference

IDSA participated in the first WHO Global Ministerial Conference on Ending TB last month in Moscow, an event that brought together 1,000 participants including ministers of health and finance and civil society representatives from across the globe. The Moscow Declaration adopted by delegations attending the conference includes a commitment to concerted action toward ending tuberculosis by 2030. Actions will include scaled-up TB case-finding, research and development of new drug regimens, better diagnostics, and a safe and effective vaccine as well as patient-centered care and policies. The declaration is widely viewed as an important precursor to the United Nations High Level Meeting on Tuberculosis scheduled for September 2018.

An announcement by the so-called BRICS countries--Brazil, the Russian Federation, India, China and South Africa--about the creation of a collaborative research institute on tuberculosis was viewed as an important initiative to spur the development of new tools for TB prevention, diagnosis and treatment. IDSA offered comments (PDF) on the Moscow Declaration, many of which were incorporated into the final document, and will be engaged over the coming year to ensure that the United States government and the UN General Assembly provide leadership and resources to tackle the world’s leading infectious disease killer.

Science Speaks

With infectious disease support on the line, Science Speaks looks at global goals and progress

As policymakers in Washington and around the world confront public health planning and spending decisions, IDSA priorities that include biomedical research funding and infectious disease preparedness at home and around the world are on the line. The IDSA global Science Speaks blog followed some of the issues with:

HIVMA Medical Students Program

The 2018 HIVMA Medical Students Program is currently accepting applications for up to three years of funding for HIV-related clinical research projects and mentorship. Please encourage your student population to apply. The deadline is February 15, 2018. For more information, please contact Kumba Sennaar at ksennaar@hivma.org or visit our website.

HIVMA Clinical Fellowship Program

Applications are being accepted now for the 2018-2019 HIVMA Clinical Fellowship program. The program supports newly trained physicians with gaining HIV clinical experience working with medically underserved patient populations. With a goal of increasing the number of HIV physicians and strengthening commitments to clinical care for HIV-infected patients in minority communities, HIVMA awards grants to support one-year of HIV clinical training to up to two fellows per year. Grants are made to institutions to support a stipend of $60,000 as well as additional funding to cover fringe benefits for one year, administrative costs and further educational opportunities. The deadline for applications is January 8, 2018. Strong preference will be given to African American and Latino candidates and to applicants pursuing training in the Southeastern U.S. More information is available on the HIVMA website.

Young Investigator Prizes Available for Human Immunology & Vaccine Research

The Michelson Prizes for Human Immunology and Vaccine Research will award $150,000 prizes to two young investigators under the age of 35 who are applying innovative research concepts to significantly advance the development of future vaccines and immunotherapies for major global diseases.

To be considered, applicants must show how they are going beyond conventional approaches in their field and how their contribution will make a lasting impact on human immunology and vaccine research. Early career scientists across a wide array of disciplines, including biomedical, bioengineering and computer science fields, are encouraged to apply.

Prizes will be awarded in June 2018 as part of a scientific conference on the Convergence of Human Immunology and Vaccine Research.

The Michelson Medical Research Foundation together with the Human Vaccines Project have established these prizes with the ultimate goal of broadening understanding of the immune system to give the scientific community new tools to prevent and control disease, potentially saving millions of lives around the world.

Pre-application deadline is Feb. 12, 2018.
Email MichelsonPrizes@HumanVaccinesProject.org to learn more.

The Year in Review

As 2017 draws to a close, reflecting on our infectious diseases profession and IDSA achievements over the year can help gauge where we stand and our hope to continue with progress next year. It is also a time to give thanks to the many dedicated member volunteers and hard-working Society staff. They keep our professional Society a vigorous and dynamic change agent. The IDSA commitment has never been stronger to improving both our patients’ health and public health worldwide while advocating to keep our field strong and attractive for the future.

Read More

Paul Auwaerter, MD, MBA, FIDSA
IDSA President

Paul Auwaerter, MD, MBA, FIDSA
IDSA President

As 2017 draws to a close, reflecting on our infectious diseases profession and IDSA achievements over the year can help gauge where we stand and our hope to continue with progress next year. It is also a time to give thanks to the many dedicated member volunteers and hard-working Society staff. They keep our professional Society a vigorous and dynamic change agent. The IDSA commitment has never been stronger to improving both our patients’ health and public health worldwide while advocating to keep our field strong and attractive for the future.

A new administration in Washington along with the current Congressional make-up meant that many vital supports for medical research, public health, and access to health care were under review with sharp cuts threatened. IDSA has been a strong advocate for federal funding of essential ID and HIV programs while also opposing repeal of the Affordable Care Act. While the federal budget for 2018 is still under negotiation as of this writing, Congress has largely rejected these significant reductions proposed for the National Institutes of Health and the Centers for Disease Control and Prevention (CDC). IDSA and HIVMA members were critical and continue this ongoing advocacy on multiple levels. By contacting lawmakers, meeting with congressional staff and other key officials, and participating in events like April’s March for Science, members raised critical awareness of publicly funded research and evidence-based policymaking.

Promoting the value of the ID specialty and ensuring that ID clinical care is fairly compensated are major priorities for IDSA. Data from the 2017 member compensation survey has attracted a great response, allowing compensation analysis across the field and our diverse membership at a level of detail not available before or elsewhere. This includes new insights into gender pay disparity, a critical issue to address. In a report to the IDSA Board of Directors in June, the Gender Disparity Task Force led by Judy Aberg, MD, FIDSA, identified contributors to gender disparities and made recommendations. IDSA has begun implementing these recommendations and in the forthcoming year, with a top-down review of IDSA governance, the Society is fully committed to this imperative.

To ensure a strong and vibrant ID workforce, we must also attract the best and the brightest to the field. A recent IDSA-sponsored Journal of Infectious Diseases supplement, expertly edited by Stephen Calderwood, MD, FIDSA, and Wendy Armstrong, MD, FIDSA, examined ID career opportunities. Articles also focused upon workforce challenges, strategies to move forward, and personal reflections on the diverse career paths available in the field. The 2017 ID fellowship match reflects an improving trend as 81.5 percent of slots filled compared to 65 percent in 2015, perhaps reflecting mentoring and recruitment efforts starting with IDSA-sponsored medical school ID interest groups and mentoring. This improvement is also an encouraging sign that the transition to an “all in” match is beginning to have a positive impact. Read more about this year’s results in this IDSA News article.

IDWeek this year attracted more than 7,500 professional attendees, the highest number ever, solidifying the meeting of IDSA, HIVMA, SHEA, and PIDS as the premier infectious diseases meeting. Newly offered “MED Talks” featured brief presentations on how to think about career options in ID, how to interview, and how to negotiate. These activities add to several existing IDSA programs to engage students and trainees in ID-related activities to further generate interest in infectious diseases and to provide support for ID fellows.

IDSA continued to support useful and relevant clinical practice guidelines in 2017, thanks to the dedication of expert panels of volunteers. These included new or updated guidelines for health care-associated ventriculitis and meningitis, infectious diarrhea, and the management of chronic pain in patients living with HIV. Also, there were several timely updates to the web-based guidance for the treatment of hepatitis C developed by IDSA and the American Association for the Study of Liver Diseases and available at HCVguidelines.org.

The IDSA’s longstanding leadership in addressing antimicrobial resistance and encouraging antimicrobial stewardship helped guide efforts to address this global and distressful problem. My immediate predecessor as president of IDSA, William Powderly, MD, FIDSA, joined the president of the American Society for Microbiology at the World Antimicrobial Resistance Congress in September for a joint keynote in which he highlighted our efforts and the leading role of ID physicians in implementing antimicrobial stewardship. Last month, IDSA announced the first recipients of its new Antimicrobial Stewardship Centers of Excellence designation. This initiative recognizes institutions that meet standards established by CDC for antimicrobial stewardship programs led by ID physicians and pharmacists trained in ID.

The IDSA Foundation has also had a transformative year, guided by a new vision: a world free from the burdens of infectious diseases. After nearly a decade of focusing predominately on global advocacy, the Foundation expanded its focus and created a new mission: to reduce the burdens of infectious diseases by advancing research, education, advocacy, and patient care. In the last year, the Foundation doubled the number of mentorship awards for medical students and residents. The IDSA Foundation has also established opportunities for both individual and corporate leadership support of our educational and research programs. Please consider in your year-end chartiable giving a donation to the Foundation.

This message highlights only some of the many important IDSA efforts over the last year. With the success of the well-attended IDWeek in San Diego, please mark your calendar to attend IDWeek 2018, Oct. 3-7, in San Francisco. The hard work of the IDWeek Program Committee and many others contribute to the success of the meeting and the Society. As we close the year, we look forward to building on these accomplishments in 2018. Please consider offering your feedback to help make IDSA as responsive as possible. You can do so by posting on MyIDSA or, if you prefer you may email me directly at: pauwaert@jhmi.edu. On behalf of IDSA, I offer you all best wishes for good health and happiness in the New Year.

ID Fellowship Match Results: Interest in ID Holds Steady

The results are in from this year’s fellowship Match and Infectious Diseases has maintained the gains we achieved last year.

Read More

The results are in from this year’s fellowship Match and Infectious Diseases has maintained the gains we achieved last year. The number of applicants was nearly identical to last year (321 vs 320 last year) and U.S. graduate interest in ID remained stable (158 applicants this year vs 162 last year). U.S. graduates filled 49.2 percent of the slots with the remainder going to U.S. foreign educated (14%), osteopathic residents (12.8%), and international medical graduates (24%). The percent of programs that filled slightly exceeded last year (66.2% vs 63.3%) and the percent of positions filled was comparable to last year (81.5% vs 79.6%).

Fifty-one programs (33.8%) failed to fill all available slots in the Match. Of these, 26 programs failed to fill any slots. Notably, the programs that did not fill all or some of their slots were not necessarily the same as last year and the geographic distribution of unfilled slots varied slightly from last year. The majority of programs that failed to fill tended to be smaller, offering 1-2 slots in this year’s Match, however, there were programs with three or greater slots that also failed to fill.

This year’s results indicate that the improvement seen last year in the Match has been maintained, and does not appear to represent a transient change. Whether this indicates enhanced interest in ID or is entirely the result of the all-in Match is uncertain but there is reason for optimism. Nevertheless, there is work to be done to build on these encouraging results. IDSA has worked hard to generate interest in ID, supporting a recruitment campaign aimed at students and residents and expanding outreach to medical students with ID interest groups and the Medical Scholars Program. The September 15 supplemental issue of Journal of Infectious Diseases provides useful information regarding careers in ID that can augment individual efforts to engage residents in our field. Additionally, robust mentorship programs, including at IDWeek, have been implemented to foster interest among residents and students in careers in ID.

The IDSA Training Program Directors Committee is committed to carefully examining this year’s Match results to better understand issues related to unfilled programs and to providing support to further improve on this year’s Match performance in the coming years. These larger scale efforts, combined with the numerous individual, local, and regional programs aimed at students and early stage trainees, should continue to foster interest in ID moving forward, expanding the numbers of trainees and ultimately the ID workforce in the coming years.

Annual Comparison of Match Results*



*Year refers to year when fellow begins fellowship

Tax Reform Bills Pose Threats to Public Health, Medical Education, Coverage

The House and Senate have passed different versions of tax reform legislation that pose serious concerns for IDSA and HIVMA. Both societies continue to weigh in with Congress as Republican leaders seek to negotiate a final bill. You can view IDSA’s most recent letter and HIVMA’s most recent statement.

Read More

The House and Senate have passed different versions of tax reform legislation that pose serious concerns for IDSA and HIVMA. Both societies continue to weigh in with Congress as Republican leaders seek to negotiate a final bill. You can view IDSA’s most recent letter and HIVMA’s most recent statement.

Both bills would increase the federal deficit by over $1 trillion over a decade. This significant deficit spending will trigger $25 billion in automatic cuts to the Medicare Program and eliminate the Prevention and Public Health Fund that currently accounts for 12 percent of the Centers for Disease Control and Prevention’s budget (though Congress is discussing passing a bill to halt this trigger). Other federal health and public health programs also would face future cuts due to reduced revenue coupled with growing federal deficits.

The House-passed tax bill contains a new barrier to researchers pursuing post-graduate education, treating tuition waived in exchange for teaching and research commitments as taxable income. This provision would put graduate education out of reach for many and deplete the pipeline of new scientists. IDSA and HIVMA staff have heard from multiple Republican Congressional offices that they are working to reject this provision in the final bill. The bill also would eliminate the student loan interest deduction, an important mechanism to reduce the significant student debt burden facing many of our nation’s graduates—particularly new physicians.

The tax bill passed by the Senate includes a repeal of the Affordable Care Act’s individual mandate, which the Congressional Budget Office estimates would increase the number of Americans without health insurance by 13 million over a decade and increase premiums in the non-group health insurance market by 10 percent annually.

Journal Club

  • β-Lactam/β-Lactamase Inhibitor Combinations for ESBL Infections in Neutropenic Patients
  • Do Integrase Inhibitors Cause Weight Gain?

Read More

In this feature, a panel of IDSA members identifies and critiques important new studies in the current literature that have a significant impact on the practice of infectious diseases medicine.

Click here for the previous edition of Journal Club. For a review of other recent research in the infectious diseases literature, see "In the Literature," by Stanley Deresinski, MD, FIDSA, in each issue of Clinical Infectious Diseases.

β-Lactam/β-Lactamase Inhibitor Combinations for ESBL Infections in Neutropenic Patients
Reviewed by Zeina Kanafani, MD, MS

A multicenter retrospective study recently published in Antimicrobial Agents and Chemotherapy assessed the efficacy of β-lactam/β-lactamase inhibitors (BLBLI) for the treatment of bloodstream infections (BSIs) caused by extended-spectrum β-lactamase (ESBL)-producing Gram-negative bacilli (GNB), compared to carbapenem therapy in an immunocompromised cohort.

A total of 259 hematologic neutropenic patients with BSI due to ESBL-GNB were retrospectively recruited. These patients were divided into two cohorts. The empirical therapy cohort (ETC) included 174 patients who received empiric therapy with BLBLI (n = 48) or a carbapenem (n = 126) and whose isolates were susceptible to the empiric therapy administered. The definitive therapy cohort (DTC) included 251 patients who received definitive therapy with BLBLI (n = 17) or a carbapenem (n = 234). The primary endpoint was the case fatality rate at 30 days from onset of BSI. Secondary outcomes included the case fatality rates at days 7 and 14, persistent and relapse of BSI, superimposed colonization or infection by an organism resistant to the study antibiotics, and any breakthrough infection.

In the ETC group, the 30-day case fatality rate was 20.8 percent in patients who received BLBLI and 13.4 percent in those treated with a carbapenem, while in the DTC group corresponding numbers were 5.8 percent with BLBLI and 15.8 percent with carbapenems. None of the differences were statistically significant. In addition, there was no significant difference in any of the secondary outcomes in the ETC and DTC groups between those treated with a carbapenem and those given BLBLI. Finally, antibiotic assignment was not found to be an independent risk factor for mortality at 30 days.

This is the first study to assess the usefulness of BLBLI for the treatment of BSI caused by ESBL-GNB in an immunocompromised cohort. As the authors concluded, the results suggest that sparing carbapenems in favor of BLBLI may be a useful strategy. However, the study was limited by its retrospective nature and the inability to recruit a larger number of patients treated with BLBLI.

(Gudiola et al. Antimicrob. Agents Chemother. 2017;61(8):e00164-17.)

Do Integrase Inhibitors Cause Weight Gain?
Reviewed by Brian R. Wood, MD

Treatment guidelines for HIV in the United States now prioritize integrase strand transfer inhibitors (INSTIs), and the majority of antiretroviral therapy (ART) starts and switches in clinical practice utilize an INSTI. A principal reason is tolerability. However, new reports raise concern about a possible association between INSTIs and weight gain.

Earlier this year, French investigators published an intriguing but preliminary research letter in AIDS detailing an observed association between dolutegravir (DTG) and weight increases. In this single-center review of 462 patients who received DTG-based ART for more than six months (most as part of an ART switch), after an average follow-up time of 276 days (+/- 76 days), mean weight gain was 3 kg and mean body mass index (BMI) increase was 1 kg/m2. One fifth of individuals experienced a weight increase of 10 percent or more on DTG. Weight gain was particularly pronounced for women, especially if receiving DTG with abacavir (ABC) and lamivudine (3TC).

A more recent report in the Journal of Acquired Immune Deficiency Syndrome adds credence to this association. In this retrospective, observational, single-center cohort analysis, researchers included HIV-infected adults with virologic suppression who had been taking efavirenz-tenofovir disoproxil fumarate-emtricitabine (EFV-TDF-FTC) for at least two years. They assessed weight changes comparing 136 individuals who switched to an INSTI-containing regimen, 34 who switched to a boosted protease inhibitor (PI)-containing regimen, and 325 who continued EFV-TDF-FTC for at least another 18 months. Of those who switched to INSTI-anchored ART, 43 percent switched to DTG-ABC-3TC, 42 percent to elvitegravir-cobicistat-TDF-FTC, and 15 percent to raltegravir plus TDF-FTC. Those who switched to INSTI-based ART gained significantly more weight compared to those who continued the baseline regimen (mean 2.9 kg at 18 months versus 0.9 kg; P = 0.003), and weight gain for those who switched to DTG-ABC-3TC was the most pronounced (mean 5.3 kg; P = 0.001 compared to EFV-TDF-FTC). There was no significant association between switching to a boosted PI and weight gain.

This is another single-center study with relatively small numbers and the findings should be confirmed with additional investigations. However, the findings are noteworthy because it is not unheard of for post-marketing research to reveal prominent ART-related side effects.

Although integrase inhibitors have become a mainstay of initial and salvage ART and offer many advantages over other options, these results indicate a need for further study into possible INSTI-related adipocyte and body composition changes. This includes studies to confirm this early data, to explore a possible biologic mechanism, to differentiate effects of various INSTIs and NRTI combinations, and to identify particular patient groups at highest risk (particularly given recent reports of INSTI discontinuations due to neuropsychiatric side effects, which similarly call out DTG as the worst offender and likewise suggest elevated risks when DTG is combined with ABC and potential elevated risk in women). While currently available INSTIs offer a dramatic improvement in tolerability over previous ART, perhaps there is still room for improvement?

(Menard et al. AIDS. 2017 Jun 19;31(10):1499-1500.)
(Norwood et al. J Acquir Immune Defic Syndr. 2017;76(5):527-531.)

For a review of other recent research in the infectious diseases literature, see "In the Literature," by Stanley Deresinski, MD, in each issue of Clinical Infectious Diseases:

November 15

  • The Twain Have Met: Carbapenemase-Producing, Hypervirulent Klebsiella pneumoniae
  • Prevention of Gonorrhea With a Meningococcal Vaccine

November 1

  • The Circulating dsDNA Viral Microbiome in Allogeneic Hematopoietic Stem Cell Transplant Recipients
  • Another Monogenic Defect in Innate Immunity Resulting in Severe Infection: IFIH1 and Respiratory Viruses

Invest in Our Path Forward with the IDSA Foundation

Each year, the IDSA Foundation provides hundreds of medical students; residents and fellows with highly effective mentorship and research opportunities. Don’t let this season of giving pass without making a gift to the IDSA Foundation’s Our Path Forward campaign.

Read More

Sonali Advani MD, MPH

As I look ahead at the path before me, I am truly grateful for the hands-on support and mentorship opportunities I received through the IDSA Foundation.

Over the past 3 years, the IDWeek Mentorship program has paired me with infectious disease mentors from different institutions and offered many opportunities for networking with other mentors during the annual meeting. I was provided with wonderful guidance for navigating my career, negotiating my first faculty position, and maintaining a positive work-life balance by my mentors. Their support and guidance has continued even after the IDWeek Mentorship program and greatly influenced my career trajectory.

Each year, the IDSA Foundation provides hundreds of medical students; residents and fellows with highly effective mentorship and research opportunities. And their efforts are paying off. For the first time in years, the field is experiencing an increase in the number of students applying for ID fellowships.

I am asking you to invest in the IDSA Foundation and its efforts to support early career health professionals like me. The need for ID professionals has never been greater. Together we can change lives!

Don’t let this season of giving pass without making a gift to the IDSA Foundation’s Our Path Forward campaign. Take it from me, your gift will inspire the next generation of ID leaders. Please donate today!

Thank you!

Sonali Advani MD, MPH
Associate Hospital Epidemiologist, Yale New Haven Hospital
Assistant Professor of Medicine, Division of Infectious Diseases
Yale School of Medicine

Help Us Improve the IDSA and HIVMA Websites!

Redesign of the IDSA and HIVMA websites is underway and we need your input! You should have received an email from us on December 8th with a member survey regarding your experiences with the current sites, and your thoughts on how they can better meet your needs. A follow up email will be sent to members early next week in case you missed the first one. Please participate in that survey. Your input is essential!

Redesign of the IDSA and HIVMA websites is underway and we need your input! You should have received an email from us on December 8th with a member survey regarding your experiences with the current sites, and your thoughts on how they can better meet your needs. A follow up email will be sent to members early next week in case you missed the first one. Please participate in that survey. Your input is essential!