Introduction

Dolutegravir (trade name: Tivicay) has been approved in Germany since January 2014 for the treatment of human immunodeficiency virus (HIV) type 1 infection in adults and children over 12 years of age, and since February 2017 also for children over 6 years of age. It is combined with other drugs used to treat the virus.

The human immunodeficiency virus (HIV) multiplies in the cells of the immune system and destroys them. Without proper treatment, the immune system of most patients with an HIV infection is weakened so much that they become seriously ill. This stage is called “AIDS” (acquired immunodeficiency syndrome). HIV cannot be cured with current antiretroviral therapies, but patients can be saved from immunodeficiency for many years and thus decrease the risk of getting AIDS. But the medication can become ineffective over time, allowing the viruses to multiply more again.

Application

Dolutegravir is available in tablet form in three doses of 10, 25 and 50 mg. If children over 12 years of age and adults are not resistant to integrase inhibitors, 50 mg of dolutegravir is taken once daily, independently of meals. If adults take dolutegravir in combination with other drugs including efavirenz, nevirapine, tipranavir / ritonavir or rifampicin, or are resistant to integrase inhibitors, the drug is taken twice daily (100 milligrams in total).

The dose depends on body weight for children between the ages of 6 and 12 years.

Other treatments

Efavirenz in combination with two other drugs such as abacavir and lamivudine or tenofovir and emtricitabine is a common drug combination for adolescents and adults starting their first HIV treatment.

Individual therapy is used for patients who have already taken drugs for HIV. Individual therapy also looks at which treatments were tried before and why they were discontinued. It is possible, for instance, that the previous treatment was ineffective or caused side effects that were too strong.

Common drug combinations for children starting their first HIV treatment are two drugs such as abacavir, lamivudine, emtricitabine or zidovudine in addition to efavirenz or nevirapine, or a protease inhibitor combined with ritonavir.

Individual therapy is used for children who have already had treatment for HIV. Here as well, therapy looks at which treatments were tried before and why they were discontinued.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) examined how dolutegravir compares with the standard therapies. IQWiG considered the following groups of patients:

  • First-line treatment in adults: Dolutegravir for those who have not received any other drugs before. Data regarding advantages and disadvantages of dolutegravir was available for this group of people.
  • Subsequent  treatment in adults: Dolutegravir in combination with individual background therapy for patients who have taken other drugs before. Data regarding advantages and disadvantages was available for this group of patients as well.
  • First-line and subsequent treatment for children over the age of 6 and adolescents: The question of whether dolutegravir as first-line or subsequent treatment might have advantages over other treatments in children and adolescents remains unanswered. The manufacturer did not provide any suitable data.

Learn more

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the "early benefit assessment of medications." On the basis of these reviews and the hearings received, G-BA passed a resolution on the added benefit of dolutegravir (Tivicay).

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