It is important for users of HIV drugs to be aware of side-effects, and report any problems they may be having to their clinical team. They (the clinical team) should then use the Yellow Card Scheme to report this, so that a true picture of adverse side-effects can be built up. Many (older) drugs were thought to be very good, but it was only after years of use that it became clear there were problems – drugs such as d4T (stavudine, or Zerit) and ddi (didanosine, or Videx) – neither of which is now used in the UK, except in exceptional circumstances.
Dolutegravir (Tivicay, also combined with abacavir/lamivudine in Triumeq) is a new type of HIV drug…a second-generation integrase inhibitor (II). It is recommended for first-line therapy – that is, for use by newly-diagnosed patients. The drug is very effective at controlling HIV, and the research from clinical trials showed that it has a good side-effects profile. A very low rate of central nervous system (CNS) adverse events (insomnia, disturbed sleep, depression and other mood disorders) was observed in clinical trials that led to the licensing of the drug. This made it attractive for people who were struggling with efavirenz (Sustiva), which is also present in the once-a-day drug Atripla.
But doctors in Germany found that nearly 6% of their patients discontinued the drug because of CNS side-effects within 12 months, much higher than the rates observed for other integrase inhibitors. The most commonly reported problems were insomnia or sleep disturbance. Dizziness, headache, pins and needles sensations, depression and impaired concentration or slowed thinking were reported by smaller numbers of people. Women, older people and those taking the drug with abacavir were especially likely to experience CNS side-effects.
It is not clear yet how widespread this problem really is – but it highlights the need for patients to be aware, and report any problems they are having to their clinical team, so that a real-world picture can be built up over time.
The full article can be read here.