Dolutegravir for subsequent 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 have already had medical treatment for HIV. One study was available to IQWiG for the purpose of this assessment. This study involved adults with HIV who had already had HIV therapy and were resistant to at least two HIV drugs.
Participants in the study were divided into two groups. One group used dolutegravir, and the other was given the drug raltegravir. Both groups also received two additional drugs to treat HIV which were selected based on individual needs. A total of 724 people participated in this study and all data was analyzed after 48 weeks.
What advantages does dolutegravir have?
- Severe side effects: The study suggested that dolutegravir has an advantage here. It caused severe side effects in about 10 out of 100 people compared with about 15 out of 100 people who took raltegravir.
- Side effects involving the nervous system: The study suggests that doletugravir causes fewer side effects in people over the age of 50. About 12 out of 100 people from this age group who took dolutegravir had these kinds of side effects in this study. The same number was about 26 out of 100 for people over the age of 50 who took raltegravir.
Where was there no difference?
- Deaths: There was no difference here between dolutegravir and raltegravir treatments.
- 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.
- Cases of stopping treatment due to side effects: There was no difference between dolutegravir and raltegravir.
- Skin rash: There was no difference here either.
- Side effects involving muscle tissue, connective tissue or bones: There was only a minor difference between dolutegravir and raltegravir in this category.
- Psychiatric disorders: ´There was no difference in terms of side effects like insomnia or nightmares.
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.
- There were also not enough data for people who did not have an integrase inhibitor as part of their individual therapy.
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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