Introduction

The fixed-dose combination of dolutegravir / lamivudine (trade name: Dovato) has been approved in Germany since July 2019 for the treatment of type 1 HIV in adults and children aged 12 years and above.

The human immunodeficiency virus (HIV) multiplies in cells of the immune system and destroys them. Without proper treatment, the immune system of most HIV patients is weakened so much over time that they become seriously ill. This stage is called “AIDS” (acquired immunodeficiency syndrome).

Although the available medications can't cure HIV, they can prevent the immune system from becoming so weak (immunodeficiency) over the long term. But in some people the medication may become ineffective over time, allowing the viruses to multiply more again.

The fixed-dose combination of dolutegravir and lamivudine inhibits certain proteins that the virus needs in order to multiply.

Application

One tablet containing 50 mg of dolutegravir and 300 mg of lamivudine is taken once daily, with or without meals.

Other treatments

Patients with HIV usually receive individual combination treatment against the virus. This approach takes into consideration whether treatment is being started for the first time or which treatments were tried before and why they were stopped. For instance, the previous treatment might have been ineffective or caused side effects that were too severe.

Assessment

In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dolutegravir / lamivudine when compared with individual combination treatment for HIV in adults and teenagers.

To help with the assessment, the manufacturer provided usable studies containing data regarding the following cases:

  • Dolutegravir / lamivudine for the treatment of HIV in adults who had not already had treatment
  • Dolutegravir / lamivudine for the treatment of HIV in adults who had already had treatment

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More information

This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany. The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of this review and hearings received, the G-BA passed a resolution on the added benefit of dolutegravir / lamivudine (Dovato).