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当前位置:药品说明书与价格首页 >> 皮肤性病 >> 新药动态 >> FDA批准含三种抗的爱滋病口服药Atripla

FDA批准含三种抗的爱滋病口服药Atripla

——FDA批准含三种抗逆转录病毒成分的抗爱滋病药Atripla

2006-08-10 11:58:03  作者:新特药房  来源:中国新特药网天津分站  浏览次数:182  文字大小:【】【】【

 atripla是综合了三样抗爱滋病药物sustiva (efavirenz), emtriva (emtricitabine) 和 viread(tenofovir disoproxil fumarate), 一天只需服用一次的新型药物。

集三种常用抗逆转录病毒药于一体的艾滋病治疗药Atripla已获得FDA批准,该药为片剂,用药时可单独服用或与其他抗逆转录病毒药物联用。
 
Atripla是第一种每日用药一次,每次仅服一片,集Sustiva(efavirenz)、Emtriva(emtricitabine)和Viread (tenofovir disoproxil fumarate)这三种活性成分的抗艾药物。百时美-施贵宝和Gilead Sciences两家公司已成立了专门的合资公司负责该药在美国的销售,相关厂家将在96个小时之内在美国推出该药。
Sustiva、Viread和Emtriva分别在1998年、2001年及2003年通过FDA的批准。一项244名感染HIV-1的成人受试者参加的为期48周的临床试验结果显示,含这三种药物成分的复方药Atripla安全性及疗效良好。在上述实验中,80%的受试者的人体免疫缺陷病毒显著减少,而正常CD4细胞(可抵抗艾滋病毒感染的细胞)的数量大幅增加。
 
Atripla的标签信息中包括该药会导致乳酸酸中毒的警示内容。伴有慢性乙型肝炎的患者(此类患者不在适用人群之列)在治疗过程中停用Atripla后会出现严重的乙肝病情突然加剧。该药可能导致的严重不良反应还包括较为严重的肝中毒、肾功能损害和重度抑郁。在实验中,受试者用药后最常见的副作用为头痛、头晕、腹痛、恶心呕吐和皮疹。
【规格】片剂:10mg,20mg,40mg。

About ATRIPLA

ATRIPLA combines two nucleoside reverse transcriptase inhibitors (NRTIs) and one non-nucleoside reverse transcriptase inhibitor (NNRTI) in one pill.

The first and still the only entire HIV regimen in one pill daily. ATRIPLA may be taken alone or with other HIV medicines.

With the power of three HIV medicines in one pill, ATRIPLA offers an entire HIV regimen in a single daily dose, for many patients.

ATRIPLA is the #1 prescribed HIV regimen.

  • ATRIPLA is the only 1 pill daily HIV regimen with 3 DHHS-preferred meds for patients new to therapy
  • ATRIPLA is proven to lower viral load to undetectable and helps raise T-cell (CD4+) count to help control HIV through 3 years of a clinical study in patients new to therapy.
    • Through 3 years, 71% of patients taking the meds in ATRIPLA had undetectable viral loads versus 58% for
      COMBIVIR (lamivudine/zidovudine) + SUSTIVA
    • At Year 3, the average increase of CD4+ cell count was 312 cells/mm3 for patients taking the meds in ATRIPLA  versus 271 cells/mm3 for COMBIVIR + SUSTIVA

The long-term effects (beyond 3 years) of ATRIPLA are not known at this time. People taking ATRIPLA may still get opportunistic infections or other conditions that happen with HIV-1 infection.

ATRIPLA does not cure HIV-1 and has not been shown to prevent passing HIV-1 to others.

Medicines you should not take with ATRIPLA:

Do not take ATRIPLA if you are taking the following medicines because serious and life-threatening side effects may occur when taken together: Vascor® (bepridil),
Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Halcion® (triazolam), or ergot medications (for example, Wigraine® and Cafergot®).

In addition, ATRIPLA should not be taken with: Combivir® (lamivudine/zidovudine),
EMTRIVA (emtricitabine), Epivir® or Epivir-HBV® (lamivudine),
Epzicom® (abacavir sulfate/lamivudine), SUSTIVA (efavirenz),
Trizivir® (abacavir sulfate/lamivudine/zidovudine),
TRUVADA (emtricitabine/tenofovir DF), or VIREAD (tenofovir DF), because they contain the same or similar active ingredients as ATRIPLA. ATRIPLA should not be used with
HEPSERA® (adefovir dipivoxil).

Ask your doctor if ATRIPLA is right for you, and see your healthcare provider regularly. Individual results may vary.

Please click here for Important Safety Information, including information on lactic acidosis, serious liver problems, and flare-ups of hepatitis B virus (HBV).

Please click on each product's name to view Full Prescribing Information, including Boxed WARNINGS for ATRIPLA, TRUVADA, EMTRIVA, VIREAD, and Full Prescribing Information for SUSTIVA.

Synovate Healthcare Data; US HIV Monitor, Q1, 2010.
The Department of Health and Human Services.
Undetectable was defined as a viral load of less than 400 copies/mL.

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