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TheBodyPRO.com Covers CROI 2017

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Doravirine versus Darunavir

March/April 2017

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Focus on the Brain

All non-nukes are based on a chemical structure distantly related to Valium-type drugs. This means that they can get inside the brain, which is a sanctuary for HIV. However, it also means non-nukes have the potential to cause brain-related side effects (also called neuropsychiatric side effects). As an example, efavirenz was a first-generation non-nuke that is notorious for causing brain-related side effects. Examples of brain-related side effects include the following:

  • concentration problems
  • confusion
  • dizziness
  • difficulty falling asleep and/or staying asleep
  • vivid dreams
  • in rare cases depressive illness

We do not have detailed information about brain-related side effects from this study.

The overall distribution of brain-related side effects was as follows:

  • doravirine-based regimens -- 11%
  • darunavir-based regimens -- 13%

No participant left the study because of these side effects.


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Abnormal Lab Test Results

Analysis of blood samples from participants detected few severe abnormalities. If abnormal test results did occur, for the most part they were generally of mild to moderate intensity.

Here is the distribution of severely abnormal elevated blood test results:

LDL-C ("bad cholesterol")

  • doravirine-based regimens -- less than 1%
  • darunavir-based regimens -- 3%

Blood sugar

  • doravirine-based regimens -- 1%
  • darunavir-based regimens -- less than 1%

AST (a liver enzyme)

  • doravirine-based regimens -- 1%
  • darunavir-based regimens -- 3%

ALT (a liver enzyme)

  • doravirine-based regimens -- 1%
  • darunavir-based regimens -- 2%

Creatinine (used to assess kidney health)

  • doravirine-based regimens -- 1%
  • darunavir-based regimens -- 3%


Creatine Kinase (Sometimes Called Creatinine Phosphokinase)

Elevated levels of creatine kinase indicate that muscle inflammation and injury may be occurring. However, given the low levels of this issue found in this study (regardless of the regimen used) and that there were no complaints about muscle pain, it is unlikely that this was a problem.

  • doravirine-based regimens -- 2%
  • darunavir-based regimens -- 2%


More About Cholesterol and Triglycerides

Over the long-term, elevated levels of LDL-C are associated with an increased risk for cardiovascular disease. In the present study, when analyses were done on blood samples for their lipid (cholesterol and triglyceride) levels, researchers asked participants to fast before the samples were collected. As a result of deeper analysis of lipid levels, researchers found that there was a small but significant increase in LDL-C levels among participants taking darunavir. In contrast LDL-C levels fell modestly in doravirine users. Triglycerides also rose among darunavir users but declined in doravirine users.

Levels of HDL-C ("good cholesterol") rose modestly in participants regardless of which study drug they used.


Summary

Overall, the study shows that doravirine is not inferior to darunavir and is a potent and highly effective treatment, particularly for people who are initiating HIV therapy, with only some participants experiencing side effects.


Reference

Molina J-M, Squires K, Sax P, et al. Doravirine is non-inferior to darunavir + ritonavir in a phase 3 treatment-naïve trial at week 48. Conference on Retroviruses and Opportunistic Infections. 13-16 February 2017, Seattle. Abstract 45 LB.

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Related Stories

New NNRTI Doravirine Is Non-Inferior to Darunavir/Ritonavir in Phase 3 Treatment-Naive Study



This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication TreatmentUpdate. Visit CATIE's Web site to find out more about their activities, publications and services.
 


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Please note: Knowledge about HIV changes rapidly. Note the date of this summary's publication, and before treating patients or employing any therapies described in these materials, verify all information independently. If you are a patient, please consult a doctor or other medical professional before acting on any of the information presented in this summary. For a complete listing of our most recent conference coverage, click here.

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