Losing Sleep on Dolutegravir? You’re Not the Only One

Recent studies are showing that dolutegravir, an antiretroviral marketed under the name Tivicay or Triumeq (when combined with abacavir/lamivudine), may cause neuropsychiatric side effects at higher rates than clinical trials indicated. These symptoms are causing many people to cease taking Tivicay and search for more side-effect-neutral treatment medications.

Dolutegravir Facts

Dolutegravir (DTG) is an integrase strand transfer inhibitor. It works by blocking the HIV virus from inserting or integrating DNA into the DNA of the host cell. Without integration, the virus cannot replicate, helping the body to maintain a low viral load.

DTG’s approval was fast-tracked by the US Food and Drug Administration, arriving on the market by August 2013. Soon after, DTG was approved by Health Canada (November 2013) and the European Commission (January 2014).

DTG is on the World Health Organization’s List of Essential Medicines.

What Research Shows about Dolutegravir

Clinical trials of DTG showed low rates of adverse effects compared to older integrase inhibitors andantiretroviral such as efavirenz. The most common side effects include:

  • Insomnia
  • Headaches
  • Anxiety
  • Depression
  • Psychosis

Studies published since DTG’s FDA (or Canadian and European) approvals show higher incidences of neuropsychiatric side effects, which are prompting patients to switch to a different drug or drug combination.

The most compelling evidence to date comes from a 2016 German study that compared discontinuation rates of patients on three common integrase inhibitors—DTG, raltegravir (Isentress) and elvitegravir (Vitekta/Stribild). Overall, elvitegravir had the highest discontinuation rate for adverse effects. However, discontinuation prompted specifically by neuropsychiatric events in the first year of taking the drug were significantly higher for DTG compared to the other antiretroviral. The most common adverse effects reported by patients on DTG were insomnia/sleep disturbance, dizziness, headaches, poor concentration, and depression. The study also found that sex (female) and age (over 60) increased the likelihood of experiencing adverse neuropsychiatric effects.*

What to do If You Experience Psychological Side Effects from Dolutegravir

While research studies are linking DTG to an increase in insomnia, sleep disturbances and other changes in mood/mental health, no studies indicate that DTG poses any severe health risks. So, if you are on DTG and experience no adverse effects or feel that you can manage side effects, then there is no need to change your antiretroviral treatment program.

If insomnia or other adverse effects are negatively impacting your quality of life, then switching to another integrase inhibitor or other combination of antiretroviral drugs may be in your best interest.

Make an appointment with your primary healthcare provider or contact UNM Truman Health Services to discuss your treatment options with our medical team.

* Alcorn, K. (2016). Dolutegravir and central nervous system side-effects: abacavir, older age increase the risk. NAM Aidsmap. Retrieved from http://www.aidsmap.com/Dolutegravir-and-central-nervous-system-side-effects-abacavir-older-age-increase-the-risk/page/3094507/.