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27 June 2018  |  Volume 5  |  Issue 13

Each bi-weekly issue of Current UpDate highlights a few of the recent, important additions to our "What's New" and "Practice Changing UpDates" topics.

This issue features “What’s New” entries related to:
  • Dolutegravir and risk of neural tube defects
  • Venetoclax for the treatment of relapsed chronic lymphocytic leukemia
  • Updated colorectal cancer screening guidelines

To see "What's New" in your specialty (and 25 others, including drug therapy), or to read "Practice Changing UpDates" across all specialties, click here.

Dolutegravir in women of childbearing potential and risk of neural tube defects
Practice Changing UpDate: For HIV-infected women of child-bearing potential who are either planning to conceive or are not using effective contraception, we suggest not initiating or switching to dolutegravir (Grade 2C). Such women who are already taking dolutegravir should be switched to a different regimen.
A dolutegravir-containing regimen is one of the recommended antiretroviral regimens for HIV-infected individuals. Preliminary results from an observational study in Africa suggested an association between maternal dolutegravir use at the time of conception and neural tube defects in the infant (observed in 4 of 426 infants, or 0.94 percent, compared with a historical rate of 0.12 percent with other antiretroviral agents) [1,2]. Pending further data, we agree with US Department of Health and Human Services recommendations not to use dolutegravir in individuals of child-bearing potential who have plans to conceive or are not taking effective contraception [3]. Women who become pregnant while taking dolutegravir should generally continue it, as the window of risk has likely passed, but those whose last menstrual period was within the prior eight weeks can reasonably choose to switch to a different regimen after counseling about the competing risks.
1. WHO statement on dolutegravir. Geneva May 18, 2018. http://www.who.int/medicines/publications/drugalerts/Statement_on_DTG_18May_2018final.pdf.


2. US FDA. Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm608168.htm.


3. United States Department of Health and Human Resources Panel on Antiretroviral Guidelines for Adults and Adolescents, Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV, and Panel on Treatment of Pregnant Women Living with HIV and Prevention of Perinatal Transmission. Recommendations Regarding the Use of Dolutegravir in Adults and Adolescents with HIV who are Pregnant or of Child-Bearing Potential, May 30, 2018. https://aidsinfo.nih.gov/news/2109/ recommendations-regarding-the-use-of-dolutegravir-in-adults-and-adolescents-with-hiv-who-are-pregnant-or-of-child-bearing-potential.


Venetoclax for relapsed chronic lymphocytic leukemia

Venetoclax is an oral inhibitor of BCL2 used for the treatment of relapsed chronic lymphocytic leukemia (CLL). Efficacy and safety data are available from two recent trials:

  • In an international, open-label, phase 3 trial, almost 390 patients with relapsed or refractory CLL were randomly assigned to six months of bendamustine plus rituximab or to two years of venetoclax plus six months of rituximab [4]. Venetoclax plus rituximab resulted in superior progression-free and overall survival at two years.

  • An interim analysis of a multicenter, phase 2, open-label study evaluated the efficacy of venetoclax in 91 patients with heavily pretreated CLL who relapsed after, or were refractory to, ibrutinib [5]. Responses were seen in a majority; at two years, half of the patients were alive without progression regardless of the presence of high-risk genetic abnormalities (eg, del17p). In a separate report of this trial, similar outcomes were seen among 36 patients with relapse after idelalisib [6].

Based on these and other data, the US Food and Drug Administration has expanded the approval of venetoclax to patients with CLL with or without 17p deletion who have received at least one prior therapy and allows it to be given with or without rituximab. Venetoclax with or without rituximab is our preferred therapy for patients relapsing after ibrutinib. In addition, we now prefer targeted therapies such as venetoclax rather than retreatment with a prior regimen for patients who relapse after a long remission.
4. Seymour JF,Kipps TJ, Eichhorst B, et al.Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia.NEngl J Med 2018; 378:1107.


5. Jones JA,Mato AR,Wierda WG, et al.Venetoclax forchroniclymphocyticleukaemiaprogressingafteribrutinib:aninterimanalysisofamulticentre, open-label, phase 2 trial.LancetOncol 2018; 19:65.


6.Coutre S,Choi M,Furman RR, et al.Venetoclax for patients with chronic lymphocytic leukemiawhoprogressedduringorafteridelalisib therapy. Blood 2018; 131:1704.


Updated ACS guidelines on colorectal cancer screening
The American Cancer Society (ACS) has updated its colorectal cancer (CRC) screening guidelines [7]. On the basis of an apparent increase in the incidence of CRC in younger adults, the ACS guidelines now make a “qualified” recommendation to begin screening persons at average risk for CRC at age 45 years, with a strong recommendation to screen at age 50 years and above. The guidelines also now offer six testing options to select among: colonoscopy every 10 years, computed tomographic colonography (CTC) every five years, sigmoidoscopy every five years, take-home high-sensitivity guaiac-based fecal occult blood testing yearly, take-home fecal immunochemical testing (FIT) yearly, and multitargeted stool-DNA test every three years, noting that any positive result on a noncolonoscopy test should be followed up with timely colonoscopy. In including more tests, rather than prioritizing tests that could detect both polyps and cancer, the ACS notes that screening with a test acceptable to the patient is preferable to the patient declining screening. For average-risk patients, and in keeping with most guidelines, we continue to initiate screening starting at age 50 years. We prefer colonoscopy when possible, and FIT or CTC if the patient cannot or will not have colonoscopy.
7. Colorectal cancer screening for average‐risk adults: 2018 guideline update from the American Cancer Society https://onlinelibrary.wiley.com/doi/abs/10.3322/caac.21457.


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