You are leaving Medscape Education
Cancel Continue
Log in to save activities Your saved activities will show here so that you can easily access them whenever you're ready. Log in here CME & Education Log in to keep track of your credits.
 

CME/CE

FDA Approval: Dolutegravir for HIV-1 Infection

  • Authors: News Author: Robert Lowes
    CME Author: Laurie Barclay, MD
  • CME/CE Released: 9/17/2013
  • THIS ACTIVITY HAS EXPIRED FOR CREDIT
  • Valid for credit through: 9/17/2014, 11:59 PM EST
Start Activity


Target Audience and Goal Statement

This article is intended for primary care clinicians, infectious disease specialists, hematologists, and other specialists who care for patients with HIV-1 infection.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe a new FDA approval of dolutegravir for HIV-1 infection.
  2. Describe supporting evidence underlying a new FDA approval of dolutegravir for HIV-1 infection.
  3. Describe adverse events reported with dolutegravir used for HIV-1 infection.


Disclosures

As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.

Medscape, LLC, encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Robert Lowes

    Robert Lowes is a journalist for Medscape Medical News. A former senior editor at Medical Economics magazine and contributor to numerous healthcare publications, Robert has covered medicine from almost every conceivable angle — public policy, managed care, education, ethics, medical malpractice, information technology, billing and collections, waiting-room design, and first-degree murder. His articles have won major awards such as first place in the annual journalism competition of the National Institute for Health Care Management, and several have been republished in books. Robert also is an anthologized poet. He can be contacted at [email protected].

    Disclosures

    Robert Lowes has disclosed no relevant financial relationships.

Editor(s)

  • Laurie E. Scudder, DNP, NP

    Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC

    Disclosures

    Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

CME Author(s)

  • Laurie Barclay, MD

    Freelance writer and reviewer, Medscape, LLC

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Joi N. Tisdale

    CME Program Manager, Medscape, LLC

    Disclosures

    Disclosure: Joi N. Tisdale has disclosed no relevant financial relationships.


Accreditation Statements

    For Physicians

  • Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Medscape, LLC designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    This enduring material activity, Medscape Education Clinical Briefs has been reviewed and is acceptable for up to 39 Prescribed credits by the American Academy of Family Physicians. AAFP accreditation begins September 1, 2013. Term of approval is for 1 year from this date. Each Clinical Brief is approved for .25 Prescribed credits. Credit may be claimed for 1 year from the date of each Clinical Brief. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Note: Total credit is subject to change based on topic selection and article length.

    Medscape, LLC staff have disclosed that they have no relevant financial relationships.

    AAFP Accreditation Questions

    Contact This Provider

    For Pharmacists

  • Medscape, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

    Medscape designates this continuing education activity for 0.25 contact hour(s) (0.025 CEUs) (Universal Activity Number 0461-0000-13-043-H02-P).

    Contact This Provider

For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]


Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 75% on the post-test.

Follow these steps to earn CME/CE credit*:

  1. Read the target audience, learning objectives, and author disclosures.
  2. Study the educational content online or printed out.
  3. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. We encourage you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates from the CME/CE Tracker.

*The credit that you receive is based on your user profile.

CME/CE

FDA Approval: Dolutegravir for HIV-1 Infection

Authors: News Author: Robert Lowes CME Author: Laurie Barclay, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED FOR CREDIT

CME/CE Released: 9/17/2013

Valid for credit through: 9/17/2014, 11:59 PM EST

processing....

Clinical Context

Persons with HIV-1 infection benefit more from individually tailored treatment regimens than from a "one-size-fits-all" approach. Approval of new antiretroviral drugs such as dolutegravir increases the range of available options in the treatment armamentarium.

In February 2013, the US Food and Drug Administration (FDA) granted dolutegravir priority review status. On August 12, it was approved, only 4 days after approval of the first rapid diagnostic test for HIV types 1 and 2 antibodies and for the HIV-1 p24 antigen.

Study Synopsis and Perspective

On August 12, The FDA approved a new drug called dolutegravir (Tivicay) as an adjunct to other antiretroviral drugs that treat individuals infected with HIV-1, the agency announced.

Dolutegravir, an integrase strand transfer inhibitor, interferes with an enzyme needed for HIV to multiply. It is a once-a-day pill.

The new drug is indicated for HIV-infected adults who have never taken HIV antiretroviral therapy as well as for HIV-infected adults who have previously received this therapy, including other integrase strand transfer inhibitors. Clinicians also can order dolutegravir together with other antiretrovirals for children aged 12 years or older, weighing at least 40 kg, who are treatment naive or treatment experienced but have not previously received other integrase strand transfer inhibitors, a restriction not found with adults.

"HIV-infected individuals require treatment regimens personalized to fit their condition and their needs," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA."

In February, the agency granted priority review status to dolutegravir. Its approval comes 4 days after the FDA okayed the first rapid diagnostic test to spot antibodies to both HIV types 1 and 2 as well as the HIV-1 p24 antigen.

The FDA determined that dolutegravir is safe and effective on the basis of 4 clinical trials involving 2539 participants with HIV. Drug regimens for treating HIV that included dolutegravir proved effective in reducing viral loads, according to the agency. The pharmacokinetics, safety, and activity of the drug with regard to children defined in the pediatric indication were established in a fifth clinical trial.

Insomnia and headache were common adverse events observed in the clinical trials. Among the more serious adverse events were hypersensitivity reactions and abnormal liver functions among patients who also were infected with hepatitis B or C, or both. The drug's label contains instructions on how to monitor patients for such serious adverse events.

More information on the FDA decision is available on the agency Web site.

Clinical Implications

  • The FDA has approved dolutegravir, an integrase strand transfer inhibitor, to treat HIV-1 infection when used as an adjunct to other antiretroviral drugs. This once-daily pill formulation is indicated for treatment-naive HIV-infected adults as well as for HIV-infected adults previously treated with integrase strand transfer inhibitors and/or other antiretroviral therapy. Children at least 12 years old and weighing at least 40 kg may receive dolutegravir along with other antiretroviral therapy if they are treatment naive or treatment experienced, but not if they previously received other integrase strand transfer inhibitors.
  • Evidence from 4 clinical trials suggests that dolutegravir is safe and effective in reducing viral loads when used in drug regimens for treating HIV. A fifth clinical trial demonstrated the pharmacokinetics, safety, and activity of dolutegravir in children.
  • Adverse events reported in clinical trials of dolutegravir used for HIV-1 infection included common adverse events of insomnia and headache. More serious adverse events included hypersensitivity reactions and abnormal liver functions in patients coinfected with hepatitis B and/or hepatitis C. The label for dolutegravir includes information regarding monitoring of patients for serious adverse events.

CME Test

  • Print