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Elvitegravir fixed combination in HIV: Lesser benefit for treatment-naive patients
Date:9/20/2013

the comparator therapy. The studies did not provide any information on health-related quality of life.

Advantages and disadvantages regarding side effects

The picture regarding side effects and treatment discontinuations is complex: The studies used by the drug manufacturer were conducted in the United States and in Puerto Rico and included both white and non-white patients. The frequency of several side effects depended on the patients' ethnic group. Hence the advantages and disadvantages of the fixed combination versus the comparator therapy were assessed separately for these two subgroups.

Skin rash and nervous system disorders such as dizziness or headache occurred less frequently under the elvitegravir fixed combination in patients without prior treatment. Non-white study participants also discontinued treatment due to side effects less frequently than in the comparator group. On the other hand, serious adverse events and renal disorders occurred more frequently under treatment with the elvitegravir fixed combination.

Negative effects predominate

The extent of the negative effects of the fixed combination considerably outweighs the extent of the advantages. Overall, there is an indication of a lesser benefit of the elvitegravir fixed combination versus the efavirenz combination for treatment-naive patients.

The manufacturer did not submit any studies for pretreated patients in which the comparator therapies were notably adapted to the results of the prior treatment. A small selection of pre-specified antiviral substances was used instead. In addition, only patients without prior treatment were investigated in the studies. An added benefit for pretreated patients is therefore not proven.

G-BA decides on the extent of added benefit

The dossier assessment is part of the overall procedure for early benefit assessments supervised by the G-BA. After publication of the man
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Contact: Dr. Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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