Gilead wins US nod for Bixlenvo, a new HIV combo for patients with suppressed viral load

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  "detected_at": "2026-08-31T10:24:57+00:00",
  "company": {
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    "url": "https://gxpnews.net/en/2026/08/gilead-wins-us-nod-for-bixlenvo-a-new-hiv-combo-for-patients-with-suppressed-viral-load/",
    "title": "Gilead wins US nod for Bixlenvo, a new HIV combo for patients with suppressed viral load - Новости GxP",
    "excerpt": "The FDA has approved Bixlenvo, a new combination drug from Gilead Sciences, for treating HIV in adults. The drug is for people with suppressed viral load and is taken just once daily. It combines bictegravir – the backbone of Gilead’s flagship HIV drug Biktarvy – with lenacapavir, a key component of the company’s long‑term HIV treatment and prevention strategy. Gilead told CNBC that the drug would become available within days of approval. The wholesale price for a monthly course of the new drug is $4,595. Uninsured patients can obtain it for free through Gilead’s patient assistance programme, while those with commercial or private insurance can receive partial cost reimbursement through a co‑pay savings programme. The new drug is designed for patients who want to switch or simplify their treatment regimen. It is primarily aimed at those forced to take complex regimens due to drug resistance, poor tolerability of previous drugs, or for whom other options, such as single‑tablet regimens, are unsuitable. Jared Baeten, senior vice president of clinical development at Gilead, noted that about 5% of people with HIV in the United States currently take more than one pill per day. This group tends to be older and to have a long treatment history. The regulatory decision was based on positive results from the Artistry‑1 and Artistry‑2 clinical trials. The first study demonstrated...",
    "product": "lenacapavir and islatravir combination drug",
    "summary": "Gilead Sciences is partnering with MSD to develop a once-weekly oral combination drug for HIV treatment, combining lenacapavir and islatravir.",
    "planning": true,
    "image_url": "https://gxpnews.net//wp-content/uploads/2021/05/gilead.jpg",
    "confidence": 0.9,
    "product_data": {
      "name": "lenacapavir and islatravir combination drug",
      "full_text": "a once‑weekly oral combination drug with MSD that would combine lenacapavir and islatravir",
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      "medical"
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    "published_at": "2026-08-31T10:24:57Z",
    "article_sentence": "In addition, Gilead is developing a once‑weekly oral combination drug with MSD that would combine lenacapavir and islatravir.",
    "related_company_name": "MSD",
    "related_company_domain": "msd.com"
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