{"id":20655,"date":"2012-12-01T11:20:18","date_gmt":"2012-12-01T11:20:18","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=20655"},"modified":"2013-02-11T13:25:17","modified_gmt":"2013-02-11T13:25:17","slug":"updated-results-on-quad-96-week-data-from-phase-3-studies","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/20655","title":{"rendered":"Updated results on Quad: 96 week data from phase 3 studies"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

Two oral presentations presented 96 week data from the two phase 3 treatment studies for the recent approval of the single-tablet, four-drug combination of elvitegravir\/cobicistat\/tenofovir\/FTC, developed as Quad, and now approved as Stribild in the US.<\/strong><\/p>\n

Entry criteria for both studies included being treatment-naive and having an eGRF >70 mL\/min\/1.73m2.<\/p>\n

The first study comparing Quad to Atripla, reported similar rates of virologic suppressionto <50 copies\/mLof 84% vs 82% (difference 2.7%, 95% CI – 2.9% to 8.3%). This compared to 48-week results of 88% vs 84%, difference (3.6%, 95% CI -1.6% to 8.8%). A sub-group analysis, by baseline viral load below and above 100,000 copies\/mL report rates of81% vs 83%.Mean CD4 cell increases were 295 vs 273 cells\/mm3. [1]<\/p>\n

Discontinuation rates due to side effect were similar in each arm (5% vs 7%) with greater reporting of CNS side effects (47% vs 66%) and rash (21% vs 31%) with Atripla but higher rates of renal discontinuations with Quad (2%; n=7 vs 0).<\/p>\n

Two patients discontinued Quad after week 48 due to serum creatinine increases but without features of proximal renal tubulopathy. Median changes in serum creatinine (mmol\/L [mg\/dL]) at week 96 in the Quad vs Atripla arms (11.5 vs 0.9 [0.13 vs 0.01]) were similar to those at week 48 (12.4 vs 0.9 [0.14 vs 0.01]).<\/p>\n

Quad had smaller median increases (mmol\/L [mg\/dL]) in total (0.23 vs 0.47 [9 vs 18], p<0.001) and LDL cholesterol (0.23 vs 0.41 [9 vs16], p=0.011), and similar increase in triglycerides (0.05 vs 0.09 [4 vs 8], p=0.41).<\/p>\n

In the second study,96 weeks results were reported comparing Quad to the boosted PI combination of atazanavir\/ritonavir plus tenofovir\/FTC, in just over 700 treatment-naive patients.<\/p>\n

The proportion of patients with viral load <50 copies\/mL at week 96 was 83% vs 82% (difference 1.1%; 95% CI: 4.5%, 6.7%). This compared to 90% vs 87% (difference 3.0%; 95% CI: 1.9% to 7.8%) at week 48, finding Quad to be non-inferior at both timepoints. Results in patients with baseline viral load >100,000 copies\/mL were 82% vs 80% (all comparisons, Quad vs ATZ\/r respectively).<\/p>\n

Mean CD4 cell increases at week 96 were also similar between arms (256 vs 261 cells\/mm3).<\/p>\n

Discontinuation rates due to side effects were 4% vs 6%, and caused by renal complications in 3 (0.8%) vs 2 (0.6%) of patients. One person in each arm discontinued between week 48 and 96 due to elevated serum creatinine.<\/p>\n

Resistance was reported in 2% vs <1% of patients.<\/p>\n

Median increases from baseline in serum creatinine (mmol\/L [mg\/dL]) at week 96 (10.6 vs 7.1 [0.12 vs 0.08]) were similar to those at week 48 (10.6 vs 7.1 [0.12 vs 0.08]).<\/p>\n

Quad had smaller increases (mmol\/L [mg\/dL]) in triglycerides (0.06 vs 0.18 [5 vs 16], p=0.012) but greater increases in total cholesterol (0.36 vs 0.21 [14 vs 8], p=0.046) with similar changes in LDL and HDL cholesterol. Quad had smaller mean decreases (%) in BMD (hip: 3.16 vs -4.19, p=0.069, spine: 1.96 vs 3.54, p=0.049).<\/p>\n

References:<\/p>\n

    \n
  1. Zolopa A et al. Elvitegravir\/cobicistat\/emtricitabine\/tenofovir DF (Quad) has durable efficacy and differentiated safety compared to efavirenz\/emtricitabine\/tenofovir DF at week 96 in treatment-naive HIV-1-infected patients. 11th International Congress on Drug Therapy in HIV, 11-15 November 2012, Glasgow.\u00a0Oral abstract O424A.
    \nhttp:\/\/dx.doi.org\/10.7448\/IAS.15.6.18219<\/a><\/li>\n
  2. Fordyce M et al. Elvitegravir\/cobicistat\/emtricitabine\/tenofovir DF (Quad) has durable efficacy and differentiated safety compared to atazanavir boosted by ritonavir plus emtricitabine\/tenofovir DF at week 96 in treatment-na \u0308\u0131ve HIV-1-infected patients. 11th International Congress on Drug Therapy in HIV, 11-15 November 2012, Glasgow. \u00a0Oral abstract O424B.
    \n    http:\/\/dx.doi.org\/10.7448\/IAS.15.6.18220<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base Two oral presentations presented 96 week data from the two phase 3 treatment studies for the recent approval of the single-tablet, four-drug combination of elvitegravir\/cobicistat\/tenofovir\/FTC, developed as Quad, and now approved as Stribild in the US. …<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,3],"tags":[169],"class_list":["post-20655","post","type-post","status-publish","format-standard","hentry","category-conference-reports","category-antiretrovirals","tag-hiv-11-glasgow-2012"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/20655","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=20655"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/20655\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=20655"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=20655"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=20655"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}