The fixed-dose combination of the four drugs elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (trade name: Genvoya) has been approved in Germany since November 2015 for the treatment of type 1 HIV (HIV-1) in adults and teenagers over the age of 12. Since December 2017, it can also be used in children aged 6 and over if other treatments for HIV are not tolerated due to side effects.
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 over time. This stage is referred to as AIDS (acquired immune deficiency syndrome).
Although the currently available medications can't cure HIV, they can prevent immunodeficiency for many years. But the medication may become ineffective over time, allowing the viruses to multiply more again.
The fixed-dose combination with elvitegravir is swallowed whole (not chewed) in the form of a tablet once a day with a meal. One tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide.
For the first-line treatment of HIV, the following options are available:
- In children: a combination of two drugs such as abacavir, lamivudine, emtricitabine or zidovudine. Another drug is used as well, such as efavirenz, nevirapine, lopinavir, atazanavir or darunavir.
- In teenagers: the combination of abacavir and lamivudine.
- In adults: efavirenz combined with two other drugs such as abacavir and lamivudine or tenofovir and emtricitabine.
Children, teenagers and adults who have already had treatment with medication for HIV are then given individual therapy as subsequent treatment. 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 strong.
In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether the fixed-dose combination with elvitegravir has any advantages or disadvantages compared with the standard treatments for HIV-1. It assessed the advantages and disadvantages separately for the following groups:
- First-line treatment in adults: the fixed-dose combination with elvitegravir for adults who hadn't yet had treatment with other HIV medications. Data regarding the advantages and disadvantages of the elvitegravir combination is available for this group of patients.
- Subsequent treatment in adults: the fixed-dose combination with elvitegravir for adults who had already had treatment with other HIV medications. Data regarding the advantages and disadvantages of the elvitegravir combination is available for this group, too.
- No data was available for the assessment of this medication in the first-line or subsequent treatment of HIV in children and teenagers. It is therefore not possible to tell whether the elvitegravir combination has any advantages or disadvantages compared with standard treatments for children and teenagers.
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 the review and the hearings received, the G-BA passed a resolution on the added benefit of the fixed-dose combination elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide (Genvoya).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide – Benefit assessment according to §35a Social Code Book V . Dossier assessment; Commission A15-61. March 30, 2016. (IQWiG reports; Volume 380).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide – Addendum to Commission A15-61. Commission A16-27. May 27, 2016. (IQWiG reports; Volume 397).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (HIV-infected children) – Benefit assessment according to §35a Social Code Book V . Dossier assessment; Commission A18-01. April 12, 2018. (IQWiG reports; Volume 616).
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. 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.