Stribild (Page 10 of 12)

14.3 Clinical Trial Results in Virologically Suppressed HIV-1-Infected Adult Subjects with No History of Virologic Failure

In Study 115, subjects had to be on either their first or second antiretroviral regimen with no history of virologic failure, with no current or past history of resistance to the antiretroviral components of STRIBILD, and must have been suppressed (HIV-1 RNA <50 copies/mL) on a ritonavir-boosted PI in combination with TRUVADA for at least 6 months prior to screening. Subjects were randomized in a 2:1 ratio to either switch to STRIBILD (STRIBILD arm, N=293; randomized and dosed) or stay on their baseline antiretroviral regimen for 48 weeks (PI+RTV+TRUVADA arm, N=140; randomized and dosed). Subjects had a mean age of 41 years (range, 21–76), 86% were male, 80% were White, and 15% were Black. The mean baseline CD4+ cell count was 610 cells per mm3 (range, 74–1919). At screening subjects were receiving atazanavir (40%), darunavir (40%), lopinavir (17%), fosamprenavir (3%), or saquinavir (<1%) as the PI in their regimen.

In Study 121, subjects had to be on either their first or second antiretroviral regimen with no history of virologic failure, with no current or past history of resistance to the antiretroviral components of STRIBILD, and must have been suppressed (HIV-1 RNA <50 copies/mL) on a NNRTI in combination with TRUVADA for at least 6 months prior to screening. Subjects were randomized in a 2:1 ratio to either switch to STRIBILD (STRIBILD arm, N=291; randomized and dosed) or stay on their baseline antiretroviral regimen for 48 weeks (NNRTI+TRUVADA arm, N=143; randomized and dosed). Subjects had a mean age of 41 years (range, 20–72), 93% were male, 78% were White, and 17% were Black. The mean baseline CD4+ cell count was 588 cells per mm3 (range, 100–1614). Randomization was stratified by use of efavirenz in the baseline regimen. At screening subjects were receiving efavirenz (78%) (predominantly as ATRIPLA [74%]), nevirapine (17%), rilpivirine (4%) (as COMPLERA [4%]), or etravirine (1%) as the NNRTI in their regimen.

Virologic outcomes of Study 115 and Study 121 are presented in Table 13. Five treated subjects were excluded from the efficacy analysis: in Study 115, three STRIBILD subjects had protocol-prohibited documented resistance and one PI+RTV+TRUVADA subject was not on a protease inhibitor-based regimen at screening; in Study 121, one STRIBILD subject had protocol-prohibited documented resistance.

Table 13 Virologic Outcomes of Randomized Treatment in Study 115 and Study 121 at Week 48
Study GS-US-236-0115* Study GS-US-236-0121*
STRIBILDN=290 PI+RTV+TRUVADAN=139 STRIBILDN=290 NNRTI+TRUVADAN=143
*
Week-48 window is between Day 295 and 378 (inclusive).
Includes subjects who had ≥50 copies/mL in the Week-48 window, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death, or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/mL.
Includes subjects who discontinued due to an adverse event or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
§
Includes subjects who discontinued for reasons other than an adverse event, death, or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
Virologic Success HIV-1 RNA <50 copies/mL 94% 87% 93% 88%
Virologic Failure 1% 1% 1% 1%
No Virologic Data in Week 48 Window 6% 12% 6% 11%
Discontinued Study Drug Due to AE or Death 2% 1% 2% 1%
Discontinued Study Drug Due to Other Reasons and Last Available HIV-1 RNA <50 copies/mL § 4% 10% 4% 9%
Missing Data During Window but on Study Drug 0% 0% 0% 1%

14.4 Clinical Trial Results in HIV-1Treatment-Naïve Adolescent Subjects Aged 12 to Less than 18 Years

In Study 112, the efficacy, safety, and pharmacokinetics of STRIBILD were evaluated in a single group, open-label trial in HIV-1-infected treatment-naïve adolescents aged 12 to less than 18 years of age and weighing at least 35 kg (77 lbs) (N=50). Mean age was 15 years (range, 12–17); 70% were male, 68% black, and 28% Asian. At baseline, mean plasma HIV-1 RNA was 4.60 log10 copies per mL (range, 3.18–5.73), mean CD4+ cell count was 399 cells per mm3 (range, 133–734), and mean CD4+ percentage was 20.9% (range, 4.5%–41.1%). Twenty percent had baseline plasma HIV-1 RNA >100,000 copies per mL.

At Week 48, 44 of 50 (88%) adolescent patients treated with STRIBILD achieved HIV-1 RNA <50 copies per mL and 4 had HIV-1 RNA ≥50 copies per mL; 1 patient discontinued study drug; 1 had no virologic data at Week 48. The mean decrease from baseline in HIV-1 RNA was –3.16 log10 copies per mL; mean increase from baseline in CD4+ cell count was 229 cells per mm3. No emergent resistance to STRIBILD was detected through Week 48.

16 HOW SUPPLIED/STORAGE AND HANDLING

STRIBILD tablets are green, capsule shaped, film coated, and debossed with “GSI” on one side and the number “1” surrounded by a square box ( image ) on the other side. Each bottle contains 30 tablets (NDC 61958-1201-1) and a silica gel desiccant, and is closed with a child-resistant closure.

NDC 69189-1201-1 single dose pack with 1 tablet as repackaged  by Avera McKennan Hospital

Store at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (See USP Controlled Room Temperature).

  • Keep container tightly closed.
  • Dispense only in original container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Drug Interactions

Advise patients that STRIBILD may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products, including St. John’s wort [see Contraindications (4), Warnings and Precautions (5.4) and Drug Interactions (7)].

Lactic Acidosis/Severe Hepatomegaly with Steatosis

Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Advise patients that treatment with STRIBILD should be suspended if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) [see Warnings and Precautions (5.1)].

Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV

Inform patients that hepatitis B testing is recommended prior to initiating antiretroviral therapy. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF [see Warnings and Precautions (5.2)].

New Onset or Worsening Renal Impairment

Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of STRIBILD. Advise patients to avoid STRIBILD with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Warnings and Precautions (5.3)].

Bone Loss and Mineralization Defects

Inform patients that decreases in bone mineral density have been observed with the use of STRIBILD. Assessment of bone mineral density (BMD) should be considered in patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss [see Warnings and Precautions (5.5)].

Fat Redistribution

Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy, and that the cause and long-term health effects of these conditions are not known [see Warnings and Precautions (5.6)].

Immune Reconstitution Syndrome

Inform patients that in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. Advise patients to inform their healthcare provider immediately of any symptoms of infection [see Warnings and Precautions (5.7)].

Missed Dosage

Inform patients that it is important to take STRIBILD on a regular dosing schedule with food and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2.2)].

Pregnancy Registry

Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to STRIBILD [see Use in Specific Populations (8.1)].

Lactation

Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in breast milk [see Use in Specific Populations (8.2)].

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COMPLERA, EMTRIVA, GSI, STRIBILD, TRUVADA, VITEKTA, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks referenced herein are the property of their respective owners.

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