Featured Research

from universities, journals, and other organizations

Drug combination in HIV treatment has less benefit for treatment-naive patients

Date:
September 20, 2013
Source:
Institute for Quality and Efficiency in Health Care
Summary:
When taking some drug combinations to treat HIV, some side effects occur less frequently in treatment-naive patients. Serious side effects overall occur more frequently, however, and some of the results of this studied combination may not be as good as once thought.

The drug combination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil (elvitegravir fixed combination, trade name: Stribild) has been approved in Germany since May 2013 for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1). In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether an added benefit is proven for this combination over the current standard therapy.

This is not the case: No informative data are available for pretreated patients, and for treatment-naive patients, the disadvantages predominate. Particularly, AIDS-defining illnesses and serious side effects occur more frequently than with the appropriate comparator therapy.

Two appropriate comparator therapies

The Federal Joint Committee (G-BA) specified two appropriate comparator therapies according to the approval status: Treatment-naive patients, i.e. patients who had not been treated for HIV before, were to receive efavirenz in combination with tenofovir and emtricitabine or in combination with abacavir and lamivudine. Therapy in treatment-experienced patients was to be tailored to the individual depending on factors such as resistance or severe side effects in their prior treatment.

More AIDS-defining illnesses in treatment-naive patients

Two suitable randomized controlled trials of sufficient duration (48 and 96 weeks) in patients who had not been treated for HIV before were available. Regarding deaths (outcome "mortality"), there was no statistically significant difference between the elvitegravir fixed combination and the efavirenz combination. For the outcome "morbidity," there was an indication of a lesser benefit because more AIDS-defining events occurred under the elvitegravir fixed combination: about 23 out of 1000 versus 3 out of 1000 under 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.


Story Source:

The above story is based on materials provided by Institute for Quality and Efficiency in Health Care. Note: Materials may be edited for content and length.


Cite This Page:

Institute for Quality and Efficiency in Health Care. "Drug combination in HIV treatment has less benefit for treatment-naive patients." ScienceDaily. ScienceDaily, 20 September 2013. <www.sciencedaily.com/releases/2013/09/130920111435.htm>.
Institute for Quality and Efficiency in Health Care. (2013, September 20). Drug combination in HIV treatment has less benefit for treatment-naive patients. ScienceDaily. Retrieved August 27, 2014 from www.sciencedaily.com/releases/2013/09/130920111435.htm
Institute for Quality and Efficiency in Health Care. "Drug combination in HIV treatment has less benefit for treatment-naive patients." ScienceDaily. www.sciencedaily.com/releases/2013/09/130920111435.htm (accessed August 27, 2014).

Share This




More Health & Medicine News

Wednesday, August 27, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Predicting Heart Transplant Rejection With a Blood Test

Predicting Heart Transplant Rejection With a Blood Test

Ivanhoe (Aug. 27, 2014) Now a new approach to rejection of donor organs could change the way doctors predict transplant rejection…without expensive, invasive procedures. Video provided by Ivanhoe
Powered by NewsLook.com
Better Braces That Vibrate

Better Braces That Vibrate

Ivanhoe (Aug. 27, 2014) The length of time you have to keep your braces on could be cut in half thanks to a new device that speeds up the process. Video provided by Ivanhoe
Powered by NewsLook.com
Smartphone App Tracks Your Heart Rate

Smartphone App Tracks Your Heart Rate

Ivanhoe (Aug. 27, 2014) A new app that can track your heart rate 24/7 is available for download in your app store and its convenience could save your life. Video provided by Ivanhoe
Powered by NewsLook.com
Stroke in Young Adults

Stroke in Young Adults

Ivanhoe (Aug. 27, 2014) A stroke can happen at any time and affect anyone regardless of age. This mother chose to give her son independence and continue to live a normal life after he had a stroke at 18 years old. Video provided by Ivanhoe
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins