Fixed-dose combination of bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy) for the treatment of HIV

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 (HIV) multiplies in cells of the immune system and destroys them. Without treatment, the is weakened so much by the HIV 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 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.

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).

Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Bictegravir/emtricitabine/tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A18-43. September 27, 2018. (IQWiG reports; Volume 670).

IQWiG health information is written with the aim of helping people understand the advantages and disadvantages of the main treatment options and health care services.

Because IQWiG is a German institute, some of the information provided here is specific to the German health care system. The suitability of any of the described options in an individual case can be determined by talking to a doctor. informedhealth.org can provide support for talks with doctors and other medical professionals, but cannot replace them. We do not offer individual consultations.

Our information is based on the results of good-quality studies. It is written by a team of health care professionals, scientists and editors, and reviewed by external experts. You can find a detailed description of how our health information is produced and updated in our methods.

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Created on October 18, 2018
Next planned update: 2021

Authors/Publishers:

Institute for Quality and Efficiency in Health Care (IQWiG, Germany)

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