Navigation Links
Elvitegravir fixed combination in HIV: Lesser benefit for treatment-naive patients

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.

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 manufacturer's dossier and IQWiG's assessment, the G-BA conducts a commenting procedure, which may provide further information and result in a change to the benefit assessment. The G-BA then decides on the extent of the added benefit, thus completing the early benefit assessment.


Contact: Dr. Anna-Sabine Ernst
Institute for Quality and Efficiency in Health Care

Related medicine news :

1. Fixed payments not a barrier to quality of care in HMOs, study finds
2. Telesoft Publishes New Whitepaper – Fixed Services: The Forgotten Expense
3. Revolutionary Teeth in One Day Fixed Bridge Offered by Midtown Dentistry
4. How some prostate tumors resist treatment -- and how it might be fixed
5. Recent Study Shows Anesthetic Combination Allows For Quicker Recovery Post Oral Surgery, Tyler Sedation Dentist, Dr. Roy Smith, Comments
6. Gene combinations and interactions affect risk of Crohns disease
7. Los Angeles Dermatologist, Dr. Ghasri, is Now Offering $150 Off Combination of Dysport and Radiesse Treatments
8. Study shows combination stroke therapy safe and effective
9. Virus combination effective against deadly brain tumor, Moffitt Cancer Center study shows
10. Drug combination promotes weight loss in polycystic ovary syndrome
11. Twelve Minutes’ Exercise Per Week ‘Enough to Stay Fit’ in Combination with PhenObestin 37.5 to Burn Fat
Post Your Comments:
(Date:11/24/2015)... ... 2015 , ... Chiropractic student Katie Benson received a $2,500 ... Park, Kansas. Benson, a fifth-trimester student in the university’s College of Chiropractic, accepted ... 16. , “Katie is very excited and greatly appreciative to receive the Standard ...
(Date:11/24/2015)... ... November 24, 2015 , ... Sir ... customer service: the TrustDale certification. The award recognizes good companies for excellence in ... , tile and grout, and hard surface restoration company earned this recognition after ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... Bibliomotion ... Ford and Detroit Taught Me about Reinvention and Diversity by Nancy M. Schlichting, ... people suffer, with hospitals failing to adequately address the needs of patients and their ...
(Date:11/24/2015)... ... November 24, 2015 , ... Dr. Kevin Day, local family ... community stress less this holiday season. During the Indiana winter months, Vitamin D ... and the team at AlignLife want to help provide the tools needed to combat ...
(Date:11/24/2015)... IL (PRWEB) , ... November 24, 2015 , ... All her life, Don Peck’s mother ... Even her obituary said she might have been. After a 25-year search for information, ... voyager with whom she shared a last name. Turns out, it was Don’s father ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... st  Scientific Assembly and Annual Meeting of the Radiological ... in Chicago on Nov-29 th through ... st  Scientific Assembly and Annual Meeting of the Radiological Society of ... Chicago on Nov-29 th through Dec-4 th ... will present its revolutionary whole body CZT digital SPECT/CT solution at ...
(Date:11/24/2015)... 2015 Teledyne DALSA , a Teledyne Technologies ... will introduce its CMOS X-Ray detector for mammography ... to December 3, at McCormick Place in Chicago ... and interventional imaging will be on display in the South ... advanced CMOS X-Ray detectors is the industry benchmark for high ...
(Date:11/24/2015)... , Nov. 24, 2015  Boston Scientific Corporation ... the Oppenheimer 26th Annual Healthcare Conference on December 8, ... Susie Lisa , vice president, Investor Relations, will ... analyst beginning at approximately 8:35 a.m. ET. --> ... participate in a 30-minute question-and-answer session with the host ...
Breaking Medicine Technology: