Efavirenz

February 25, 2026 12:37 pm EST DOR/ISL is the first non-INSTI, two-drug regimen to demonstrate non-inferiority and a similar safety profile at Week 48 to BIC/FTC/TAF in adults living with HIV-1 who had not previously received antiretroviral treatment DOR/ISL maintained virologic suppression at Week 96 in adults with virologically suppressed HIV-1 who switched from other oral antiretroviral therapies, including BIC/FTC/TAF RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from three pivotal Phase 3 trials evaluating the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg), (MK-8591A)] in adults with HIV-1. The findings were shared in late-breaking presentations at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) being held in Denver. “We are proud to continue building on our 40-year history of HIV research with the presentation of compelling new data from our HIV pipeline at CROI this year,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Islatravir blocks HIV-1 replication through multiple mechanisms, including reverse transcriptase translocation inhibition, and could serve as the anchor for a series of two-drug, non-INSTI, daily and weekly treatment regimens. If approved, DOR/ISL will be the first of these regimens in our portfolio and may provide an important new option to help meet the evolving treatment needs of people living with HIV.” The Phase 3, double-blind, clinical trial MK-8591A-053 evaluating DOR/ISL versus bictegravir/emtricitabine/tenofovir alafenamidei [(50 mg/200 mg/25 mg),(BIC/FTC/TAF)] in adults living with HIV-1 who had not previously received antiretroviral treatment (treatment-naïve), met its primary efficacy endpoint of percentage of participants achieving viral suppression (HIV-1 RNA <50 copies/mL), demonstrating non-inferiority for DOR/ISL compared to BIC/FTC/TAF at Week 48, 91.8% and 90.6% respectively (treatment difference 1.2%, 95% CI: -3.7, 6.2, p<0.001). The safety profile was similar between both treatment groups and consistent with that observed in previous studies. Drug-related adverse events (AEs) and discontinuations due to drug-related AEs were similar between groups (14% for DOR/ISL and 18% for BIC/FTC/TAF; 1.1% for DOR/ISL and 2.2% for BIC/FTC/TAF, respectively). These data, which are being published simultaneously in The Lancet HIV, build on the previously reported Phase 3 data in adults with virologically suppressed HIV-1 and will form the basis of future regulatory applications. “These new Phase 3 results are meaningful, showing that an investigational two-drug regimen without an INSTI demonstrated non-inferior efficacy and a comparable safety profile versus BIC/FTC/TAF in previously untreated adults with HIV-1, including those with advanced disease,” said Dr. Jürgen K. Rockstroh, professor of medicine, head of the HIV Outpatient Clinic at the University of Bonn. “This study evaluated a diverse, global population, and included a significant proportion of participants with high viral loads and low CD4 counts. These findings add to the growing evidence supporting the potential role of DOR/ISL in HIV care.” New 96-week data from the Phase 3 MK-8591A-052 and MK-8591A-051 trials evaluating DOR/ISL vs. BIC/FTC/TAF or baseline antiretroviral therapy (bART), in participants with virologically suppressed HIV-1 and who were switched to DOR/ISL, were also presented. In both trials, DOR/ISL maintained high rates of viral suppression at Week 96 and had a similar safety profile to BIC/FTC/TAF and bART. The 48-week data from these trials supported the initial New Drug Application (NDA) for DOR/ISL for the treatment of HIV-1 infection in adults who are virologically-suppressed on a stable antiretroviral regimen; the U.S. FDA has set a target action date of April 28, 2026 for the application under the Prescription Drug User Fee Act (PDUFA). In the U.S., doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals as a single agent (PIFELTRO) and a component of a single-tablet regimen [DELSTRIGO; doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF)]. “As people living with HIV age, managing other health conditions becomes a reality for many, making it especially important to have treatment options that can help meet each person’s unique health needs,” said Dr. Amy Colson, director of research at Community Resource Initiative, Cambridge, Massachusetts. “Over time, people may need to adjust their HIV treatment regimens because of comorbidities, concerns about toxicities, tolerability challenges, or a desire for regimens with fewer medications. These 96-week data are encouraging, showing a non-INSTI option like investigational DOR/ISL could offer an important alternative.” About the Phase 3 data from MK-8591A-053 MK-8591A-053 is an ongoing Phase 3 randomized, active-controlled, double-blind, clinical trial evaluating the efficacy and safety of investigational, once-daily DOR/ISL (100 mg/0.25 mg) versus BIC/FTC/TAF in adults living with HIV-1 infection who had not previously received antiretroviral treatment. Participants were randomized 1:1 to DOR/ISL (n=269) or BIC/FTC/TAF (with matching placebos) (n=267), stratified by screening CD4+ T-cell count (<200 cells/mm³) and HIV-1 RNA (>100,000 copies/mL). The primary efficacy endpoint was the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 (non-inferiority margin 10%). Of the total participants enrolled in the trial, 36.8% had baseline HIV-1 RNA >100,000 copies/mL, 10.3% had HIV-1 RNA >500,000 copies/mL and 17.2% had baseline CD4+ T-cell count <200 cells/mm3. At Week 48, virological efficacy as measured by the percentage of participants with HIV-1 RNA levels < 50 copies/mL, was comparable in participants on DOR/ISL versus BIC/FTC/TAF with screening HIV-1 RNA >100,000 copies/mL (94.0% vs 87.6%, respectively) and >500,000 copies/mL (90.3% vs 84.4%, respectively). Drug-related AEs were reported in 14.1% of participants on DOR/ISL and 18.0% on BIC/FTC/TAF and discontinuations due to AEs (1.1% vs. 2.2%) were similar in both groups. Immune reconstitution was similar in DOR/ISL vs. comparator with no between-group differences in mean increases in CD4+ T-cell counts or total lymphocyte counts (TLC). About the Phase 3 data from MK-8591A-052 MK-8591A-052 is a Phase 3, randomized, active-controlled, double-blind, clinical trial to evaluate the efficacy and safety of a switch to investigational, once-daily DOR/ISL (100 mg/0.25 mg) in adults with HIV-1 infection that has been virologically suppressed on BIC/FTC/TAF (50 mg/200 mg/25 mg). In this trial, 513 adults with HIV-1 who had virologic suppression for three months or more on BIC/FTC/TAF, no history of treatment failure and no known resistance to DOR were randomized (2:1) and switched to DOR/ISL (n= 342) or continued treatment with BIC/FTC/TAF (n=171). The primary efficacy endpoint, the percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (non-inferiority margin 4%), was met, demonstrating non-inferiority to BIC/FTC/TAF; 1.5% of participants who switched to DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 0.6% on BIC/FTC/TAF (treatment difference 0.9%, 95% CI -1.9, 2.9). Results at Week 48 were recently published in The Lancet. At Week 96, DOR/ISL continued to demonstrate similar efficacy compared to BIC/FTC/TAF; 1.5% of participants on DOR/ISL had a viral load of ≥50 copies/mL compared to 1.2% of participants on BIC/FTC/TAF (treatment difference 0.3%, 95% CI -2.8, 2.4); 88.9% of participants on DOR/ISL maintained virologic suppression (HIV-1 RNA <50 copies/mL) compared to 90.1% of participants continuing BIC/FTC/TAF (treatment difference -1.2%, 95% CI -6.5, 5.0). No hypothesis testing was performed for these secondary endpoints. The safety profile for DOR/ISL at Week 96 continued to be similar to BIC/FTC/TAF with no new safety findings. No additional drug-related serious adverse events were reported in any group between Week 48 and Week 96. At Week 96, rates of discontinuation due to AEs were similar for both groups (3.2% vs. 2.9%). There were no differences between trial arms in CD4+ T-cell count or TLC changes through Week 96. About the Phase 3 data from MK-8591A-051 MK-8591A-051 is a Phase 3, open-label randomized, active-controlled, clinical trial to evaluate the efficacy and safety of a switch to investigational, once-daily DOR/ISL (100 mg/0.25 mg) in adults with HIV-1 infection that has been virologically suppressed using bART. In this trial, 551 adults with HIV-1 RNA <50 copies/mL for three months or more on oral 2- or 3-drug ART, with no history of treatment failure and no known virologic resistance to DOR, were randomized 2:1 and switched to DOR/ISL (n= 366) or continued bART (n=185), stratified by bART regimen. The primary efficacy endpoint, percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 (non-inferiority margin 4%), was met, demonstrating DOR/ISL to be non-inferior to bART; 1.4% of participants who received DOR/ISL had a viral load of ≥50 copies/mL at Week 48, compared to 4.9% on bART (treatment difference -3.6%, 95% CI -7.8, -0.8). After Week 48 of the comparative portion of the study, all participants received open-label DOR/ISL through Week 144. Results at Week 48 were recently published in The Lancet. At Week 96, 1.9% of participants who continued on DOR/ISL for 96 weeks had HIV-1 RNA ≥50 copies/mL and 1.1% of participants who switched from bART to DOR/ISL at Week 48. Additionally, 92.6% of participants who were on DOR/ISL through 96 weeks and 96.6% of participants who switched to DOR/ISL at Week 48 maintained virologic suppression (HIV-1 RNA <50 copies/mL) at Week 96. At Week 96, there were similar rates of drug-related AEs between those who continued on DOR/ISL (13.7%) for 96 weeks and for those who switched from bART to DOR/ISL at Week 48 (11.3%) and rates of discontinuations due to AEs for those on DOR/ISL for 96 weeks (1.1%) and for those who switched from bART to DOR/ISL at Week 48 (0.6%) were similar. The mean percent change in total lymphocyte and CD4 counts were similar for participants who continued on DOR/ISL and switched from bART to DOR/ISL. No participants discontinued treatment due to decreased CD4+ T-cell count or TLC. About Islatravir (MK-8591) and Merck’s HIV Research Islatravir (MK-8591) is Merck’s investigational nucleoside analog that blocks HIV-1 replication by multiple mechanisms including inhibition of reverse transcriptase translocation, resulting in immediate chain termination and induction of structural changes in the viral DNA. Islatravir is under evaluation in multiple ongoing early and late-stage clinical trials in combination with other antiretrovirals for potential daily and once-weekly treatments for HIV-1, with islatravir serving as the anchor medicine in these two-drug regimens. Islatravir in combination with Gilead’s lenacapavir is in Phase 3 development as a novel oral once-weekly treatment for HIV-1 [ISLEND-1 (NCT06630286) and ISLEND-2 (NCT06630299)], and islatravir in combination with our company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) ulonivirine (MK-8507) is in Phase 2b development (MK-8591B-060, NCT06891066 and MK-8591B-062, NCT07266831) as an oral once-weekly treatment. MK-8527 is the company’s investigational, novel, once-monthly, oral candidate for pre-exposure prophylaxis (PrEP) for HIV-1. The Phase 3 EXPrESSIVE-11 (MK-8527-011, NCT07044297) trial is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among people likely to be exposed to HIV-1 in 16 countries. The Phase 3 EXPrESSIVE-10 (MK-8527-010, NCT07071623) trial is evaluating the safety and efficacy of MK-8527 as PrEP to reduce the risk of sexually acquired HIV-1 infection among women and adolescent girls in sub-Saharan Africa. Both trials are now enrolling. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here. Indications and usage for PIFELTRO® (doravirine) and DELSTRIGO® (doravirine, lamivudine, and tenofovir disoproxil fumarate) in the U.S. PIFELTRO is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine. DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO. Selected Safety Information Warning: Posttreatment Acute Exacerbation of Hepatitis B Virus (HBV) for DELSTRIGO All patients with HIV-1 should be tested for the presence of HBV before initiating ARV therapy. Severe acute exacerbations of HBV have been reported in people with concomitant HIV-1 and HBV who have discontinued products containing lamivudine or tenofovir disoproxil fumarate (TDF), which are components of DELSTRIGO. Patients coinfected with HIV-1 and HBV who discontinue DELSTRIGO should be monitored with both clinical and laboratory follow-up for at least several months after stopping DELSTRIGO. If appropriate, initiation of anti-HBV therapy may be warranted. Contraindications PIFELTRO and DELSTRIGO are contraindicated when coadministered with drugs that are strong cytochrome P450 (CYP)3A enzyme inducers (including the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and phenytoin; the androgen receptor inhibitor enzalutamide; the antimycobacterials rifampin and rifapentine; the cytotoxic agent mitotane; and the herbal product St. John’s wort (Hypericum perforatum)), as significant decreases in doravirine plasma concentrations may occur, which may decrease the effectiveness of DELSTRIGO and PIFELTRO. DELSTRIGO is contraindicated in patients with a previous hypersensitivity reaction to lamivudine. Warnings and Precautions Severe Skin Reactions Severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), have been reported during the postmarketing experience with doravirine-containing regimens. Discontinue PIFELTRO or DELSTRIGO, and other medications known to be associated with severe skin reactions, immediately if a painful rash with mucosal involvement or a progressive severe rash develops. Clinical status should be closely monitored, and appropriate therapy should be initiated. New or Worsening Renal Impairment Renal impairment, including cases of acute renal failure and Fanconi syndrome, have been reported with the use of TDF. DELSTRIGO should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs). Cases of acute renal failure after initiation of high-dose or multiple NSAIDs have been reported in people living with HIV with risk factors for renal dysfunction who appeared stable on TDF. Prior to or when initiating DELSTRIGO, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue DELSTRIGO in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Discontinue DELSTRIGO if estimated creatinine clearance declines below 50 mL/min. Bone Loss and Mineralization Defects In clinical trials in adults living with HIV, TDF was associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism. Serum parathyroid hormone levels and 1,25 Vitamin D levels were also higher. Cases of osteomalacia associated with proximal renal tubulopathy have been reported with the use of TDF. The effects of TDF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults are unknown. Immune Reconstitution Syndrome Immune reconstitution syndrome can occur, including the occurrence of autoimmune disorders with variable time to onset, which may necessitate further evaluation and treatment. Drug Interactions Because DELSTRIGO is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. Coadministration of PIFELTRO with efavirenz, etravirine, or nevirapine is not recommended. If DELSTRIGO is coadministered with rifabutin, take one tablet of DELSTRIGO once daily, followed by one tablet of doravirine (PIFELTRO) approximately 12 hours after the dose of DELSTRIGO. If PIFELTRO is coadministered with rifabutin, increase PIFELTRO dosage to one tablet twice daily (approximately 12 hours apart). Consult the full Prescribing Information prior to and during treatment for more information on potential drug-drug interactions. Dosage and Administration/Specific Populations Renal Impairment Because DELSTRIGO is a fixed-dose combination tablet and the dosage of lamivudine and TDF cannot be adjusted, DELSTRIGO is not recommended in patients with estimated creatinine clearance less than 50 mL/min. Adverse Reactions The most common adverse reactions with DELSTRIGO (incidence ≥5%, all intensities) were dizziness (7%), nausea (5%), and abnormal dreams (5%). The most common adverse reactions with PIFELTRO (incidence ≥5%, all intensities) were nausea (7%), dizziness (7%), headache (6%), fatigue (6%), diarrhea (6%), abdominal pain (5%), and abnormal dreams (5%). By week 96 in DRIVE-FORWARD, 2% of adult participants in the PIFELTRO group and 3% in the darunavir+ritonavir (DRV+r) group had adverse events leading to discontinuation of study medication. By week 96 in DRIVE-AHEAD, 3% of adult participants in the DELSTRIGO group and 7% in the efavirenz (EFV)/emtricitabine (FTC)/TDF group had adverse events leading to discontinuation of study medication. In DRIVE-FORWARD, mean changes from baseline at week 48 in LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) were pre-specified. LDL-C: -4.6 mg/dL in the PIFELTRO group vs 9.5 mg/dL in the DRV+r group. Non-HDL-C: -5.4 mg/dL in the PIFELTRO group vs 13.7 mg/dL in the DRV+r group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, mean changes from baseline at week 48 in LDL-C and non-HDL-C were pre-specified. LDL-C: -2.1 mg/dL in the DELSTRIGO group vs 8.3 mg/dL in the EFV/FTC/TDF group. Non-HDL-C: -4.1 mg/dL in the DELSTRIGO group vs 12.7 mg/dL in the EFV/FTC/TDF group. The clinical benefits of these findings have not been demonstrated. In DRIVE-SHIFT, mean changes from baseline at week 24 in LDL-C and non-HDL-C were pre-specified. LDL-C: -16.3 mg/dL in the DELSTRIGO group vs -2.6 mg/dL in the PI + ritonavir group. Non-HDL-C: -24.8 mg/dL in the DELSTRIGO group vs -2.1 mg/dL in the PI + ritonavir group. The clinical benefits of these findings have not been demonstrated. In DRIVE-AHEAD, neuropsychiatric adverse events were reported in the three pre-specified categories of sleep disorders and disturbances, dizziness, and altered sensorium. Twelve percent of adult participants in the DELSTRIGO group and 26% in the EFV/FTC/TDF group reported neuropsychiatric adverse events of sleep disorders and disturbances; 9% in the DELSTRIGO group and 37% in the EFV/FTC/TDF group reported dizziness; and 4% in the DELSTRIGO group and 8% in the EFV/FTC/TDF group reported altered sensorium. The safety of DELSTRIGO in virologically suppressed adults was based on week 48 data from participants in the DRIVE-SHIFT trial. Overall, the safety profile in virologically suppressed adult participants was similar to that in participants with no ARV treatment history. Serum ALT and AST Elevations: In the DRIVE-SHIFT trial, 22% and 16% of participants in the immediate switch group experienced ALT and AST elevations greater than 1.25 X ULN, respectively, through 48 weeks on DELSTRIGO. For these ALT and AST elevations, no apparent patterns with regard to time to onset relative to switch were observed. One percent of participants had ALT or AST elevations greater than 5 X ULN through 48 weeks on DELSTRIGO. The ALT and AST elevations were generally asymptomatic, and not associated with bilirubin elevations. In comparison, 4% and 4% of participants in the delayed switch group experienced ALT and AST elevations of greater than 1.25 X ULN through 24 weeks on their baseline regimen. Pregnancy/Breastfeeding There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PIFELTRO or DELSTRIGO during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Inform individuals with HIV-1 infection of the potential risks of breastfeeding, including: (1) HIV-1 transmission (in HIV-1–negative infants), (2) developing viral resistance (in HIV-1–positive infants), and (3) serious adverse reactions in a breastfed infant similar to those seen in adults. Merck’s Commitment to HIV For 40 years, Merck has been committed to scientific research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has been pioneering in the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV. We are researching for real life and want to ensure people are not defined by HIV. Our work focuses on transformational innovations, collaborations with others in the global HIV community, and access initiatives aimed at the goal of helping to end the HIV epidemic for everyone. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2025 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Please see Prescribing Information for PIFELTRO (doravirine) at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf and Patient Information for PIFELTRO at: https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf Please see Prescribing Information for DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate) at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_pi.pdf and Patient Information for DELSTRIGO at: https://www.merck.com/product/usa/pi_circulars/d/delstrigo/delstrigo_ppi.pdf _______________________ ibictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY) is a registered trademark of Gilead Sciences, Inc. Media Contacts: Eilyn Segura (203) 940-6259 Deb Wambold (215) 779-2234 Investor Contacts: Peter Dannenbaum (732) 594-1579 Damini Chokshi (732) 594-1577

核心提示 ：中国抗艾滋病药物保障体系日益完善，已形成"国家免费方案+医保报销+自费补充"的多元保障格局，彰显国家对HIV感染者健康权益的深切关怀。在医保"双通道"政策助力下，大幅减轻了患者经济负担。近年来抗艾滋病药品进展最快，随着国产及原研药品价格下降，为不同经济条件和治疗需求的患者提供优质可及的治疗选择，让"用得上药、用得起好药"真正落地。 一、中国HIV治疗药物体系概览 三轨并行的治疗保障 保障类型 适用人群 费用负担 代表药物 国家免费方案 所有确诊患者 免费 替诺福韦+拉米夫定+依非韦伦（替拉依） 医保双通道 职工医保及居民医保参保患者 60-90%报销 必妥维、艾诺米替片、多伟托、多拉米替等 自费 需要创新药患者 自费 进口原研药、高端创新药 2026年价格趋势 • 必妥维 ：医保谈判价降至901.2元/月（原价3680元/月之后为1125元/月） • 多替拉韦 ：化合物专利于2026年4月到期，之后国产仿制药品会上线，参考国际经验，仿制药上市后价格会大幅下降。 • 国产创新药 ：艾诺米替片价格稳定，性价比优势明显 • 长效注射剂 ：2026年1月起价格腰斩，4800元/2个月 二、主流单片复合制剂深度对比 （必妥维、艾诺米替片、多伟托、绥美凯、多拉米替片），以湖南医保为例： 核心单片制剂横向对比 药品名称 商品名 成分组合 月费用 职工医保月自付 居民医保月自付 核心优势 适用人群 必妥维 Biktarvy 比克替拉韦+恩曲他滨+TAF 901.2元 约270元 约361元 整合酶抑制剂，病毒抑制率>99%，肝肾毒性低 初治/经治人群，追求生活质量 艾诺米替片 复邦德 艾诺韦林+拉米夫定+TDF 724.5元 约217元 约290元 国产1类创新药，血脂代谢优势，DDI少 心血管风险高、合并HBV 多伟托 Dovato 多替拉韦+拉米夫定 749.5元 约225元 约300元 双药方案，简化治疗，副作用少 经治患者，减少药物负担 绥美凯 Triumeq 多替拉韦+阿巴卡韦+拉米夫定 2880元（已停产） 自费 自费 最早的三合一复方单片制剂 HLA-B*5701阴性患者 多拉米替片 Delstrigo 多拉韦林+拉米夫定+TDF 837元 约251元 约335元 NNRTI类复方，神经副作用少 不能耐受整合酶抑制剂 注 ：以上价格为2026年最新医保支付标准，月费用按每月30天计算。 药物特点详细对比 1. 必妥维（比克恩丙诺片） 最新价格 ： 901.2元 /瓶（30片），较原价下降75.5% 核心优势 ： • 整合酶抑制剂，病毒抑制率高 • 对肾脏和骨骼毒性低 • 高耐药屏障，适合初治和经治患者 • 单片每日一次，依从性最佳 2. 艾诺米替片（复邦德） 最新价格 ： 724.5元 /瓶（24.15元/片×30片） 核心优势 ： • 国产1类创新药，价格优势明显 • 血脂代谢影响小，适合心血管风险高患者 • 药物相互作用少（经CYP2C19代谢） • 对HBV有抑制作用 3. 多伟托（多替拉韦钠片） 最新价格 ： 749.5元 /瓶（30片） 核心优势 ： • 双药简化治疗方案 • 第二代整合酶抑制剂，耐药屏障高 • 起效快，病毒抑制率高 • 肾毒性低 4. 绥美凯（多替拉韦+阿巴卡韦+拉米夫定） 最新价格 ： 2880元 /瓶（30片）， 目前已在国内停产 核心优势 ： • 三合一单片复方制剂 • 起效快，病毒抑制率高 • 不含替诺福韦，肾功能影响小 停产背景说明 ： • 2026年1月，外资药品"断供"名单拉长，GSK等跨国药企的老药因利润薄、集采后市场销售归零而撤出中国市场 • 绥美凯（含阿巴卡韦）作为传统抗艾药物，逐渐被新一代整合酶抑制剂复方制剂取代 • 目前患者可通过海外正规渠道购买，但需谨慎选择合法渠道 5. 多拉米替片（多拉韦林+拉米夫定+TDF） 最新价格 ： 837元 /瓶（30片），2026年医保支付标准 核心优势 ： • NNRTI类复方制剂 • 神经副作用（头晕、失眠）发生率低于依非韦伦 • 血脂代谢影响小 三、其他重要抗HIV药物现状 核苷类骨干药物 药品名称 商品名 月费用 职工医保月自付 居民医保月自付 核心优势 注意事项 达可挥 Descovy 2230元 自费 自费 含TAF，肾毒性低，适用于肾功能不全 需与其他药物联用，非完整方案 舒发泰 Truvada 1980元 自费 自费 阻断效果确切，经验丰富 含TDF，长期使用需监测肾功能 艾诺韦林 艾邦德 257.4元 约77元 约103元 中枢神经系统副作用少 需与其他抗病毒药物联用 多替拉韦钠片 特威凯 885元 自费 自费 第二代整合酶抑制剂，高耐药屏障 暂未纳入医保，需自费 特威凯（多替拉韦钠片）现状 ： • 价格 ：885元/盒（50mg×30片），暂未纳入医保 • 2026年4月专利到期 ：预计仿制药价格大幅下降 • 适用性 ：需与其他NRTIs联用，作为核心成分 • 未来展望 ：未来有望全面进入医保和集采，价格进一步降低，甚至可能进入国免方案。 达可挥（恩曲他滨丙酚替诺福韦片）现状 ： • 价格 ： 2230元 /月（36元/片×30片） • 优势 ：含TAF，肾毒性显著低于TDF，适用于肾功能不全患者 • 限制 ：作为NRTI骨干药物，需与其他抗逆转录病毒药物联用 • 用途 ：既用于HIV治疗，也用于暴露前预防（PrEP） 四、长效注射剂突破性进展 2026年最新价格与适用性 注射方案 药品名称 注射周期 单次费用 年费用 职工医保年自付 居民医保年自付 适用条件 双针组合 卡替拉韦+利匹韦林 2月/次 4800元 28,800元 约8,640元 约11,520元 病毒载量<50拷贝/mL 研发中 长效6月一针 6月/次 未定 未定 未定 未定 待国内上市公布 卡替拉韦+利匹韦林（2月一针）最新信息 ： • 2026年1月1日起价格腰斩 ： ◦ 卡替拉韦注射液（万凯锐）：3878元/针（原价7918元） ◦ 利匹韦林注射液（瑞卡必）：922元/针（原价1882元） ◦ 单次治疗总费用：4800元（含两针） • 年费用 ： 28,800元 （6次注射），第一年需7针。 四、新药研发与未来展望 新药研发管线 国内外药企竞速布局 ： • 吉利德科学 ：7款方案押注未来十年 • 江苏艾迪药业 ：ACC017片（新一代整合酶抑制剂）III期临床试验 • 齐鲁制药 ：多替拉韦仿制药已获批，等待专利到期 • 安徽贝克、东北制药 ：积极布局抗艾仿制药 治疗模式创新 ： • 从"每日服药"到"每月一针" • 从"多药组合"到"单片复方" • 从"终身服药"到"功能治愈探索" 结语 2026年，中国抗艾滋病治疗已进入"高效低毒、多元选择"时代。必妥维价格降至901.2元/月，国产创新药艾诺米替片性价比优势凸显，长效注射剂价格腰斩进入可及时代。通过合理选择药物组合、充分利用医保"双通道"政策，大多数患者可以以可负担的费用获得高质量的治疗。 未来3-5年，随着多替拉韦专利到期、仿制药上市、长效注射剂普及，中国HIV治疗费用将进一步降低，治疗模式将发生革命性变化。建议在医生指导下，结合自身经济条件、健康状况和生活方式，选择最适合的治疗方案。 参考资料 ： 1. 湖南省医疗保障局《医保药品"双通道"单行支付管理办法》（2026年1月1日施行） 2. 国家医保局《国家基本医疗保险药品目录》（2025年版） 3. 江苏艾迪药业《抗HIV领域两款创新药续约进入国家医保目录公告》（2025年12月） 4. 医问医答《艾滋病药物自费价格》（2026年2月） 5. 比克恩丙诺片苏州医保目录信息（2026年） 6. 湖南药事服务网《艾诺米替片价格信息》（2026年2月）