Introduction

The fixed-dose combination of bictegravir, emtricitabine and tenofovir alafenamide (trade name: Biktarvy) has been approved in Germany since June 2018 for the treatment of HIV-1 in adults.

The human immunodeficiency virus (HIV) multiplies in cells of the immune system and destroys them. Without treatment, the immune system is weakened so much by the HIV infection that serious diseases arise. This stage is called “AIDS” (acquired immunodeficiency syndrome).

Although the currently available medications can't cure HIV, they can prevent immunodeficiency permanently. But in some people the medication may become ineffective over time, allowing the viruses to multiply more again.

The fixed-dose combination of bictegravir / emtricitabine / tenofovir alafenamide inhibits certain proteins which the virus needs in order to multiply.

Application

One tablet containing 50 mg of bictegravir, 200 mg of emtricitabine and 25 mg of tenofovir alafenamide is taken once daily, with or without meals.

Other treatments

The first-line treatments for adults are the drugs rilpivirine or dolutegravir, which are each used in combination with two other drugs such as tenofovir alafenamide and emtricitabine or abacavir and lamivudine. Instead of tenofovir alafenamide, the drug tenofovir disoproxil is also an option.

Adults who have already taken medication for HIV are generally given individually tailored combination therapy for HIV. This type of treatment takes into consideration which treatments were tried before and why they were stopped. For instance, the previous treatment may have been ineffective or caused side effects that were too severe.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether the fixed-dose combination of bictegravir / emtricitabine / tenofovir alafenamide has any advantages or disadvantages for adults with HIV-1 when compared with the current standard treatments.

The manufacturer provided a total of 5 studies involving adults who had previously had treatment and adults who had not.

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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 the review and the hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination of bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy).