关于我们

Gilead snares data backing Truvada-to-Descovy switch in PrEP

吉利德捕获支持 PrEP 中 Truvada 转移到 Descovy 数据,患者寿命有望延长

2019-03-15 21:34:00 FiercePharma

本文共1249个字,阅读需4分钟

标签: 医疗学科 肿瘤
相关阅读
Gilead Sciences has the data it’ll need to start transitioning patients taking Truvada for PrEP over to Descovy, a drug with a longer patient life. But once Truvada generics hit, it might be a different story. The Big Biotech recently touted noninferiority data showing that Descovy had matched Truvada when it came to preventing HIV infection. Numerically speaking, Descovy beat out its predecessor, though its seven HIV cases to Truvada’s 15 came out to a difference that wasn’t statistically significant. The “numerical Descovy benefit” was “likely driven by noncompliance and enrollment errors,” Leerink Partners’ Geoffrey Porges wrote in a note to clients. Still, the result “sets the stage for Gilead to actively transition the >$2 billion in current PrEP revenue for Truvada to Descovy,” he said, adding that investors would likely expect most of that revenue haul to head Descovy’s way before Truvada’s September 2021 patent expiration. RELATED: Trump's HIV pledge comes as Gilead pumps cash into Truvada for PrEP But while “the trial results will provide Gilead with marketing ammunition” to switch scripts over to Descovy, the differences between the two products “remain modest, and it is difficult to tell how much of the transition will stick” after Truvada generics hit, Porges noted. In the study, Descovy did come out significantly ahead of Truvada on the safety side, though Porges described its bone and kidney benefits as “small.” Still, the difference may convince physicians and patients to use the medicine; people are taking PrEP therapy longer than originally expected, increasing the importance of metabolic safety. Payers, on the other hand? For them, Descovy may be a tougher pill to swallow. “At this stage paying about $18,000 per year for a 1% difference in Bone Mineral Density and a 2-4 mL/min difference in renal function might challenge the generosity of post-2020 government and private payers,” Porges wrote. RELATED: Gilead takes HIV prevention message to TV, pushing PreP awareness with hipster ad As Gilead gears up for the Truvada-to-Descovy transition, it's also pouring money into PrEP awareness. The company “actually put a significant amount of additional funding” behind Truvada for PrEP this year, commercial chief Laura Hamill said on Gilead's fourth-quarter earnings call, and it brought two DTC campaigns to the airwaves in 2018 to build buzz. Gilead is counting on HIV to bring in big sales as the company finds its footing elsewhere. Hep C revenues have flagged in recent years, prompting the company to dive into oncology with its Kite buy. But CAR-T drug Yescarta has hardly been an instant success; on the contrary, it’s been slow to get off the ground, as has fellow CAR-T therapy and archrival Kymriah from Novartis.
吉利德科学(Gilead Sciences)提供的数据显示,他们需要开始将 Truvada 用于 PrEP 的患者转移到 Descovi ,一种患者寿命更长的药物。但一旦 Truvada 仿制药上市,这可能是一个不同的故事。 大生物科技公司最近大力宣扬非劣性数据,表明 Descovy 在预防艾滋病毒感染方面与 Truvada 相匹配。从数字上讲, Descovy 击败了它的前任,尽管它的7例 HIV 病例与 Truvada 的15例之间的差异在统计学上并不显著。 LerinkPartners 的 GeoffreyPorgs 在给客户的一份报告中写道,“数值 Descovy 好处”很可能是由不合规和注册错误导致的。 不过,这一结果“为吉利德(Gilead)积极将 Truvada 目前20亿美元的 PrEP 收入转移到 Descov 打下了基础,”他说。他还补充说,投资者可能会预计,大部分收入都会在 Truvada 2021年9月专利到期前引领 Descov 的发展。 相关信息:在吉利德(Gilead)将现金注入 Truvada 以换取 PrEP 之际,特朗普做出了艾滋病毒承诺 但 Porges 指出,尽管“试验结果将为吉利德(Gilead)提供营销弹药”,将脚本切换到 Descovi ,但这两种产品之间的差异“仍然不大,而且很难判断在 Truvada 仿制药遭遇冲击后,转型将坚持多少”。 在这项研究中, Descovy 确实在安全性方面明显领先于 Truvada ,尽管 Porges 将其骨骼和肾脏的益处描述为“小”。尽管如此,这种差异可能会说服医生和患者使用这种药物;人们接受 PrEP 治疗的时间比最初预期的要长,这增加了代谢安全的重要性。 另一方面,付款人?对他们来说, Descovy 可能是一种更难吞咽的药丸。Porges 写道:“目前阶段,以每年1%的骨密度差异和2-4毫升/分钟的肾功能差异支付约1.8万美元,可能会挑战2020年后政府和私人部门的慷慨。” 相关:吉利德(Gilead)将 HIV 预防信息带到电视上,用 hipster 广告宣传 PreP 当吉利德(Gilead)为 Truvada-to-Descovy 转换做准备时,它也在为 PrEP 意识注入资金。该公司商业首席执行官劳拉•哈米尔( Laura Hamill )在吉利德(Gilead)的第四季度财报电话会议上表示,该公司今年在 Truvada 背后“实际上投入了大量额外资金”,并在2018年将两场 DTC 活动带到了空中,以制造轰动效应。 吉利德(Gilead)指望艾滋病毒能带来巨大的销售,因为该公司在其他地方找到了立足点。近几年来,惠普 C 的收入出现了下滑,促使该公司通过收购 Kite 进入肿瘤治疗领域。但是 CAR-T 药物 Yescarta 并不是一个立竿见影的成功,相反,它的起步很慢, CAR-T 疗法和诺华(Novartis)的主要竞争对手 Kymriah 也是如此。