Dolutegravir for first-line treatment of HIV in adults
In the spring of 2014 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assessed which advantages and disadvantages dolutegravir has compared with previous standard therapies in people who are having initial treatment for HIV. The assessment was based on two relevant studies comparing dolutegravir with efavirenz. One study compared two groups who took both dolutegravir and a fixed combination of either abacavir / lamivudin or tenofovir / emtricitabin. In the other study, one group used dolutegravir with the fixed combination of abacavir / lamivudin, while the other group was given the fixed combination of efavirenz / tenofovir / emtricitabin.
The first study included 103 people in its analysis, and the second study involved 844 participants. The study data were analyzed after 96 weeks.
The following results apply to people who have not yet taken any other medication to treat HIV.
What advantages does dolutegravir have?
- Side effects like nervous system disorders and skin rashes: Rashes were less common in people who used dolutegravir. About 5 out of 100 people who took dolutegravir had a rash – compared with about 14 out of 100 people who took efavirenz. Dolutegravir also had fewer nervous system disorder side effects in men than the other treatment. In these studies about 27 out of 100 men who took dolutegravir developed a nervous system disorder. In the group of men who took efavirenz it was 55 out of 100. There was no difference in women.
- Cases of stopping treatment due to side effects: The studies showed an advantage for the dolutegravir treatment. About 3 out of 100 people who took dolutegravir discontinued treatment because of side effects. This number was about 12 out of 100 for participants who used efavirenz.
Where was there no difference?
- Deaths: There was no difference between dolutegravier and efavirenz.
- Number of AIDS cases: A weakened immune system caused by an HIV infection makes a number of different bacterial, viral or fungal infections more likely. Some types of tumors are also more common. The success of a particular therapy can also be measured by whether these illnesses become less common in people who have the treatment. The study showed no difference between the two treatments.
- Severe side effects: Dolutegravir did not have any advantages or disadvantages compared with efavirenz in terms of frequency of severe side effects.
- Side effects involving muscle tissue, connective tissue or bones: There was no difference here either.
- Psychiatric disorders: The difference between dolutegravir and efavirenz in terms of side effects like insomnia or nightmares was not significant.
What questions remain unanswered?
- Quality of life: The studies did not include any data relevant to the influence of dolutegravir or efavirenz on quality of life, so it is not possible to tell whether dolutegravir has any advantages or disadvantages compared with standard therapies.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Dolutegravir – Benefit assessment according to §35a Social Code Book V. Dossier assessment A14-08. Cologne: IQWiG. May 15, 2014.
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