The fixed-dose combination of the four drugs darunavir, cobicistat, emtricitabine and tenofovir alafenamide (trade name: Symtuza) has been approved in Germany since September 2017 as a treatment for HIV type 1 in teenagers over the age of 12 (with a body weight of at least 40 kilos) and adults. The human immunodeficiency virus (HIV) multiplies in 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 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 can become ineffective over time, allowing the viruses to multiply more again.
The four drugs are taken as a fixed-dose combination in the form of a tablet, once a day with a meal. One tablet contains 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine and 10 mg of tenofovir alafenamide.
The first-line treatments for adults and teenagers 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. Adults also have the option of using the drug tenofovir disoproxil instead of tenofovir alafenamide.
Teenagers and adults who have already taken medication for HIV are generally given individually tailored treatment 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 strong.
In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the darunavir fixed-dose combination compared with the standard treatments for people with HIV type 1.
The manufacturer provided one study involving only adults who were already having treatment with other drugs for HIV. In the study, 763 people switched to the darunavir fixed-dose combination, while 378 people received one of the following standard treatments:
- Darunavir in combination with cobicistat or ritonavir and emtricitabine / tenofovir disoproxil
- Atazanavir in combination with cobicistat or ritonavir and emtricitabine / tenofovir disoproxil
- Lopinavir in combination with ritonavir and emtricitabine / tenofovir disoproxil
The following results were found:
What are the advantages of the darunavir fixed-dose combination?
- No advantages were found compared with the standard treatments.
What are the disadvantages of the darunavir fixed-dose combination?
- Disorders of the nervous system: The study suggests that the fixed-dose combination has a disadvantage here: 15 out of 100 patients who took the fixed-dose combination developed disorders of the nervous system. This was the case for about 9 out of 100 people in the comparison group who had standard treatments.
- Life expectancy: None of the participants passed away during the course of the study.
- Number of AIDS-related illnesses: A weakened immune system caused by an HIV infection makes a number of illnesses such as certain bacterial, viral or fungal infections more likely. The success of a particular treatment can also be measured by whether these illnesses become less common in people who have the treatment. There have been no cases of AIDS-related illnesses in the study so far.
- Gastrointestinal problems and skin conditions: There was no difference regarding these side effects.
- Serious side effects: There was no difference here either: In both groups, 7 to 8 out of 100 people had severe side effects.
- Treatment stopped due to side effects: About 1 out of 100 people in each group stopped the treatment due to side effects.
What remains unanswered?
- Health-related quality of life: The manufacturer didn’t provide any data on this.
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 darunavir / cobicistat / emtricitabine / tenofovir alafenamide (Symtuza).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Darunavir-cobicistat-emtricitabine-tenofovir alafenamide (HIV infection) – Benefit assessment according to §35a Social Code Book V . Dossier assessment; Commission A17-48. December 22, 2017. (IQWiG reports; Volume 572).
IQWiG health information is written with the aim of helping
people understand the advantages and disadvantages of the main treatment options and health
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