June 2016 Australian Public Assessment Report for Elvitegravir / Cobicistat / Emtricitabine / Tenofovir alafenamide (as fumarate) Proprietary Product Name: Genvoya Sponsor

First round benefit-risk assessment

Download 1.9 Mb.
Size1.9 Mb.
1   ...   5   6   7   8   9   10   11   12   13

First round benefit-risk assessment

First round assessment of benefits

The benefits of Genvoya in the proposed usage are:

  • Higher treatment response rate with Genvoya (92.4%) compared with the currently approved Stribild (90.4%). This confirmed equivalence

  • Significant reduction in loss of bone density in Genvoya cohort compared with the Stribild cohort.

Figure 7. Comparison bone density loss; Genvoya compared with Stribild

  • This reduction in bone loss was apparent in both hip and spine DEXA scans

  • Improvement and reversal in bone loss and reduction of laboratory markers of bone resorption in patients switched from E/C/F/TDF to E/C/F/TAF

  • Bone density loss was reduced in E/C/F/TAF cohorts of patients who had baseline mild to moderate renal impairment

  • No additional adverse reactions for Genvoya compared with the approved Stribild. Low level of drug discontinuation due the study medication and equal between Genvoya and Stribild (8:0.9% versus. 13: 1.5%). No SAEs resulting in death were related to study medications

  • Renal toxicity observed with Stribild, not found with Genvoya as shown by significantly reduced parameters of renal toxicity in the E/C/F/TAF group compared with the E/C/F/TDF group

Figure 8. Parameters of renal toxicity; Genvoya compared with Stribild

  • Improvement in parameters of renal function in cohort of E/C/F/TDF group when switched to E/C/F/TAF

  • Fractures were not common in either comparative groups and not related to study medication as almost all were due to trauma

  • Non-significant increases in blood lipids noted in the E/C/F/TAF group compared with the E/C/F/TDF group.

First round assessment of risks

The risks of Genvoya in the proposed usage are:

  • That the apparent improvement in bone density observed in this submission did not include a substantial number of elderly men and post-menopausal women. This is understandable, given the epidemiology and demography of the HIV-1 infected populations in the study countries. It is these populations who are at most risk of have bone density problems when taking life-long HIV-1 therapies. The sponsor may be requested to maintain a post-marketing strategy to determine if the bone density advantages of Genvoya are sustained over the long term

  • The proportion of patients with advanced HIV-1 disease was small in all studies, although because the overall cohort numbers were large, the actual number of patients appears reasonable. The sponsor will need to investigate the efficacy and safety of E/C/F/TAF in patients with advanced disease to determine if Genvoya is effective and safe for this cohort, as it appears to be from sub analysis of the submitted studies.

First round assessment of benefit-risk balance

The benefit-risk balance of Genvoya, given the proposed usage, is favourable.

First round recommendation regarding authorisation

Genvoya is indicated for the treatment of HIV-1 infection in adults and paediatric patients 12 years of age and older without any known mutations associated with resistance to the individual components of Genvoya.

It is recommended that authorisation is approved for Genvoya.

Clinical questions

No clinical questions were raised.

Share with your friends:
1   ...   5   6   7   8   9   10   11   12   13

The database is protected by copyright ©dentisty.org 2019
send message

    Main page