Aiming for Gilead’s HIV lead, GSK touts Dovato switching data
GlaxoSmithKline’s ViiV Healthcare already boasts an approval for Dovato, a two-drug HIV regimen, in newly diagnosed patients. And it just added some new data that aims to at least draw level with market leader Gilead in already-treated patients.
Six months after patients switched to Dovato from a triple-drug regimen that contains Gilead’s Vemlidy (TAF), the ViiV drug was as effective at suppressing HIV as the triple-drug regimens were for who stayed on their original drugs and no Dovato patients developed treatment resistance, the company said Wednesday.
The top-line data from the Tango study showed that virally suppressed people can switch from TAF-containing triplets to Dovato and therefore reduce the number of medicines they’re exposed to, ViiV’s head of global research and medical strategy, Kimberly Smith, M.D., said in a statement.
However, the concern among industry watchers has been around the two-drug approach’s long-term efficacy since it uses only one nucleoside analog, or nuke, that stops HIV from replicating, rather than the traditional two. ViiV is determined to prove its case to that end. The Tango study will continue to follow patients and compare the two groups’ viral loads through week 144.
RELATED: GSK's Dovato chalks up first 2-drug regimen nod for new HIV patients, but will doctors use it?
Still, data from a controlled clinical trial might not be enough to change the treatment paradigm. Many clinicians worry that more patients could miss doses in the real world, and when that happens, patients on dual regimens like Dovato might develop resistance more easily than those on triple combos.
In a recent survey, Credit Suisse conducted in 30 U.S.-based doctors, Gilead’s TAF-based three-drug regimen Biktarvy turned out to be the most preferred therapy for anticipated use over the next two years in both treatment-naïve and switch patients.
“While Dovato (dolutegravir + lamivudine) has comparable efficacy and safety in a clinical trial setting, physicians generally preferred a three-drug single-tablet regimen like Biktarvy, as respondents demonstrated concern over disease resistance in two-drug regimens,” CS analyst Evan Seigerman said in a Wednesday note. Because of “a clear preference for Biktarvy” and a “modest” enthusiasm for ViiV’s doublets, “Gilead is well-positioned to maintain market share in HIV,” he concluded.
RELATED: GSK's Shingrix skyrockets toward the £1B mark as HIV drugs falter
New IQVIA U.S. prescription data also provides a glimpse into the hard time ViiV is having with its dual-drug regimens, including Dovato and Juluca, which is approved for previously treated patients. Gilead’s and ViiV’s HIV new-to-brand market shares were “very stable” in the second quarter, Credit Suisse analysts said in a recent investor note. Currently, Gilead holds a majority 73% new-to-brand share, while ViiV only has 16%. Both Juluca and Dovato—both containing Tivicay (dolutagravir)—are gradually growing, but that growth isn't coming at Gilead's expense.
RBC Capital analyst Brian Abrahams’ team, also tracking IQVIA numbers, noted that Dovato scripts are running at less than one-sixth the rate that Biktarvy enjoyed in its ninth full week of launch, “reaffirming our view that GSK’s dual regimen is unlikely to be a significant competitor to Gilead’s HIV franchise,” he said in a recent report.
In the first quarter, ahead of Dovato’s U.S. go-ahead, Juluca generated sales of £70 million ($87.5 million), only £8 million more than its Q4 total. In comparison, Biktarvy chipped in $739 million to Gilead’s Q1 U.S. sales after just a year on the market.
葛兰素史克公司的 ViiV Healthcare 公司已经吹嘘批准 Dovato(一种两药 HIV 治疗方案)用于新诊断的患者。而它只是增加了一些新的数据,旨在至少在已经接受治疗的患者中与市场领导者吉利德平起平坐。在患者从包含吉利德公司 Vemlidy (TAF) 的三联药物治疗方案转为 Dovato 治疗 6 个月后,该公司周三表示,ViiV 药物在抑制 HIV 方面与三联药物治疗方案一样有效,因为三联药物治疗方案针对的是那些仍在使用其原有药物的患者,并且没有 Dovato 患者出现治疗耐药。Tango 公司的全球研究和医疗策略负责人 Kimberly Smith 博士在一份声明中说,Tango 公司研究的首要数据显示,病毒被抑制的人可以从含有 TAF 的三胞胎转换为 Dovato,从而减少他们所接触的药物数量。会议第 13 届数字制药公司 East Digital Pharma East 于 9 月 17-20 日回到宾夕法尼亚州会议中心,聚集了来自生物技术公司和制药公司的超过 1000 名与会者,以更好地理解如何提出商业计划,证明预算和创新的合理性,以及去风险化建议被关闭——本质上,理解他们如何能够回到办公室并成为其内部数字需求的拥护者。加入我们,并节省 15% 的标准费率时,您注册的折扣代码 DPE19Fierce。然而,今天登记的行业观察家们一直关注两种药物的长期疗效,因为它只使用一种核苷类似物或 nuke 阻止 HIV 复制,而不是传统的两种。ViiV 决心为此证明自己的论点。Tango 研究将继续随访患者,并比较两组患者至第 144 周的病毒载量。相关:GSK 的 Dovato 为新 HIV 患者制定了首个 2 药治疗方案 nod,但医生会使用吗?尽管如此,对照临床试验的数据可能不足以改变治疗模式。许多临床医生担心,在现实世界中,更多的患者可能会漏服药物,而当这种情况发生时,使用 Dovato 等双重治疗方案的患者可能比使用三联联合治疗方案的患者更容易产生耐药性。瑞士信贷最近在 30 名美国医生中开展了一项调查,Gilead 基于 TAF 的三药方案 Biktarvy 被证明是未来两年预期用于初治和转换患者的最优选疗法。CS 分析师 Evan Seigerman 在周三的报告中说:“虽然 Dovato (dolutegravir + lamivudine) 在临床试验中的疗效和安全性相当,但医生通常更喜欢像 Biktarvy 这样的三药单片方案,因为受访者表现出对两药方案中疾病耐药性的担忧。”因为“对 Biktarvy 的明显偏爱”,以及对 ViiV 的双线产品的“适度”热情,“Gilead 完全有能力维持在 HIV 领域的市场份额,”他总结道。相关消息:GSK 的 Shingrix 一跃向 1 亿英镑的大关,原因是 HIV 药物在美国的新 IQVIA 步履蹒跚。处方数据还提供了 ViiV 在其双药治疗方案(包括批准用于既往治疗患者的 Dovato 和 Juluca)方面所面临的困难。瑞士信贷分析师在最近的一份投资者报告中表示,Gilead 和 ViiV 的 HIV new-to-brand 市场份额在第二季度“非常稳定”。目前,Gilead 占据了大部分 73% 的新品牌份额,而 ViiV 只有 16%。Juluca 和 Dovato——都含有 Tivicay (dolutagravir)——都在逐渐增长,但这种增长并不是由吉利德付出代价的。RBC Capital 分析师 Brian Abrahams 的团队也跟踪了 IQVIA 数字,他们指出,Dovato scripts 的运行速度不到 Biktarvy 在上市后第 9 个完整星期的速度的六分之一,“重申了我们的观点,即 GSK 的双重方案不太可能成为吉利德 HIV 专营权的重要竞争对手,”他在最近的一份报告中表示。第一季度,领先于 Dovato 的美国继续往前走,Juluca 创造了 7,000 万英镑(合 8,750 万美元)的销售额,仅比其第四季度的总收入多出 800 万英镑。相比之下,Biktarvy 为吉利德的 Q1 美国分拆了 7.39 亿美元。上市一年后的销售额
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