In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of doravirine compared with the standard treatments for people who have HIV-1 infection.
The manufacturer only provided data to make an indirect comparison.
In scientific research, a direct comparison is a comparison made between two medications in a single study. Half of the participants in the study are given medication A, and the other half receive the standard treatment. After the study is completed, the numbers of certain events in each group – such as deaths, occurrences of symptoms or side effects – are compared.
Indirect comparisons, on the other hand, involve two different studies (in the simplest case): One study compares medication A with medication X. The other compares medication X with the standard treatment. Then the results for medication A from the first study are compared with the results for the standard treatment from the second study. The results of this kind of comparison are generally less reliable than a direct comparison.
Six studies were available for the purpose of the indirect comparison of doravirine. In three of the studies, doravirine was compared with efavirenz or darunavir. In the other three studies the standard treatment of dolutegravir was compared with either efavirenz or darunavir. Each of the medicines was combined with two more medications.
The indirect comparison showed the following results in people who have not yet taken any other medication to treat HIV:
What are the advantages and disadvantages of the fixed-dose combination?
The indirect comparison showed no advantages or disadvantages in comparison to the standard treatment of dolutegravir and two other medications.
No difference
- Number of AIDS-related illnesses: Various bacterial, viral and fungal infections are more likely if the immune system is weakened due to HIV. Some types of tumors are also more common. The success of a particular treatment can be measured by whether these illnesses are less common in people who have the treatment. There was no difference between the treatments in the indirect comparison.
- No difference was found in terms of the following, either:
- Life expectancy
- Severe side effects
- Treatment stopped due to side effects
What remains unanswered?
Quality of life: The studies didn't look into quality of life.