Background:
People with HIV take drugs to keep the amount of virus in their body low. One type of these drugs, called integrase strand transfer inhibitors (INSTIs), can cause weight gain over time. Weight gain can cause diabetes, heart disease, and other serious issues. Researchers want to understand how INSTIs cause weight changes.
Objective:
To see how a common INSTI, dolutegravir (DTG), affects how the body uses energy. DTG will be compared with a non-INSTI drug, tenofovir alafenamide (TAF).
Eligibility:
Healthy people aged 18 to 55.
Design:
Participants will be screened. They will have a physical exam and blood tests. They will have a nutritional assessment and tests of their heart function.
Participants will have 2 inpatient stays at the clinic. Each stay will be for 11 nights, with a 3-week break between.
Both DTG and TAF are gel caps swallowed once per day by mouth. Participants will take 1 drug for 8 days during each stay.
Participants will have tests to see how their body uses energy:
They will spend 23 continuous hours in a special room that measures how much oxygen they breathe in and how much carbon dioxide they breathe out. They will do this a total of 6 times.
They will have a DEXA (dual-energy X-ray absorptiometry). DEXA is a kind of X-ray that measures body fat and bone density.
They will lie on a table. Electrodes will be placed on their hands and feet to measure body fat and lean body mass.
They will stand still on a platform for about 30 seconds. High-resolution laser cameras will scan their bodies.

Start Date24 Apr 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

ChiCTR2500098753

/ SuspendedPhase 4IIT

Safety and efficacy of TAF in pregnant women with chronic hepatitis B in the first and second trimesters: a multicenter prospective cohort study

Start Date31 Mar 2025

Sponsor / Collaborator

The Third Affiliated Hospital of Guangzhou Medical University Stomatology

NCT06589518

/ Not yet recruitingPhase 2IIT

A Prospective, Single Center Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide Conversion in Liver Transplant Patients

This clinical trial aims to confirm the efficacy and safety of Vemlia® tablets (Tenofovir alafenamide) in liver transplant patients with hepatitis B, focusing on their effects on renal function.
HBV reactivation post-liver transplantation can result in a post-transplant mortality rate of up to 50% within two years, making prophylaxis critical. Currently, a combination therapy of HBIG and nucleotide analogues is commonly used. Among the nucleotide analogues (NA), entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are frequently used as first-line therapies. However, both ETV and TDF have nephrotoxicity, requiring caution in patients with chronic kidney disease. Specifically, 18% of liver transplant patients develop chronic kidney disease due to immunosuppressant use, making the appropriate use of antiviral drugs to preserve renal function crucial.
TAF has been reported through RCTs to be more effective than TDF in preserving renal function and bone density, while showing similar antiviral effects. However, these studies have been conducted exclusively on general chronic liver disease patients. Although multicenter studies have been reported for liver transplant patients, they were retrospective and involved a limited number of patients.
Therefore, the primary objective of this study is to assess the impact of converting to TAF on renal function preservation in liver transplant patients taking antivirals for HBV prophylaxis. The secondary objectives are to evaluate the antiviral effect on HBV, the impact on lipid profiles, and the effectiveness in preserving bone density.

Start Date01 Mar 2025

Sponsor / Collaborator

Samsung Medical Center

100 Clinical Results associated with Tenofovir Alafenamide Fumarate

100 Translational Medicine associated with Tenofovir Alafenamide Fumarate

100 Patents (Medical) associated with Tenofovir Alafenamide Fumarate

2,027

Literatures (Medical) associated with Tenofovir Alafenamide Fumarate

31 Dec 2025·HIV Research & Clinical Practice

Bictegravir/emtricitabine/tenofovir alafenamide in clinical practice for people with HIV: final 24-month effectiveness and safety outcomes in key populations in the observational BICSTaR cohort

Article

Author: Uriel, Alison ; Watanabe, Dai ; Robineau, Olivier ; Choy, Chiaw Yee ; Mallolas, Josep ; Marchetti, Giulia ; Thorpe, David ; Yang, Chia-Jui ; Vogelmann, Roger ; Berrevoets, Marvin ; D’Amato, Lisa ; Heinzkill, Marion ; Ramroth, Johanna ; Trottier, Benoit ; De Barra, Eoghan ; Marongiu, Andrea ; Elbirt, Daniel ; Lee, Sun Hee ; Gündüz, Alper

BACKGROUND:

BICtegravir Single Tablet Regimen (BICSTaR) is an observational cohort study evaluating the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in treatment-naïve (TN) and treatment-experienced (TE) people with HIV.

OBJECTIVE:

To present final pooled 24-month outcomes for the full cohort.

METHODS:

Prospective data were pooled from TN and TE adults with HIV initiating B/F/TAF in routine clinical practice across 14 countries (data collection: 25/06/2018-29/12/2023). Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), persistence, and safety. Outcomes were also analysed in key populations.

RESULTS:

Of 2,074 (483 TN, 1,591 TE) participants included, most were male (85%), White (70%), and had ≥1 comorbidity (66%). Median (Q1, Q3) age was 45 (35, 54) years. At 24 months, 94% of TN and 96% of TE participants had HIV-1 RNA <50 copies/mL (missing = excluded analysis). These values were 88% and 86%, respectively, in a discontinuation = failure analysis. Effectiveness remained high across all key populations at 24 months. Median (Q1, Q3) CD4 count increased by 257 (127, 447) cells/µL in TN and 40 (-70, 153) cells/µL in TE participants (both p < 0.001). There was no reported treatment-emergent resistance to B/F/TAF. Persistence was high at 24 months (TN, 95%; TE, 91%). Drug-related adverse events occurred in 11% of TN and 12% of TE participants, leading to B/F/TAF discontinuation in 5%.

CONCLUSIONS:

B/F/TAF was generally well tolerated over 24 months, with high effectiveness and persistence observed among a broad range of people with HIV.

31 Dec 2025·HIV Research & Clinical Practice

Evaluation of the effect of 48 weeks of BIC/F/TAF and DRV/c/F/TAF on platelet function in the context of rapid ART start

Article

Author: Boffito, Marta ; Henderson, Merle ; Whitlock, Gary ; Khawaja, Akif A. ; Taylor, Graham P. ; Fidler, Sarah ; Soler-Carracedo, Alfredo ; Emerson, Michael

INTRODUCTION:

The BIC-T&T study aimed to determine the efficacy of bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/c/F/TAF) at suppressing viral load in a two-arm, open-label, multi-centre, randomised trial under a UK test-and-treat setting. This sub-study aimed to evaluate potential off-target cardiovascular impact by examining ex vivo platelet function.

METHODS:

Platelets were isolated by centrifugation of citrated blood from participants attending Chelsea and Westminster Hospital or St Mary's Hospital at Week 48 following enrolment. Platelet activation was assessed by real-time flow cytometry to examine integrin activation and granule release and platelet aggregation was evaluated by light transmission aggregometry. Statistical significance was determined by 2-way ANOVA with a Šidák's multiple comparisons post-test.

RESULTS:

An analysis of 21 participants was performed at Week 48 (96% male and 48% white; mean (range) age was 37 (23-78) years). No difference between arms was observed in ADP-, collagen- or thrombin receptor activator for peptide (TRAP)-6-evoked platelet α_IIbβ₃ integrin activation, granule release or platelet aggregation in response to any of the agonists tested. Despite differences in the demographics between treatment arms, the presence of an unboosted integrase inhibitor or boosted protease inhibitor in a test-and-treat setting did not impact platelet function.

CONCLUSIONS:

Our study provides no evidence of differences in downstream platelet responses between participants taking BIC/F/TAF compared to DRV/c/F/TAF following 48 wk of treatment. Further data are required to explore whether there are biologically significant off-target effects, including effects on platelets and other components of the cardiovascular system between these two test-and-treat regimens.

CLINICAL TRIAL NUMBER:

NCT04653194.

01 Jun 2025·CLINICAL BIOCHEMISTRY

The case of a bloody mess – Bictegravir/emtricitabine/tenofovir alafenamide induced colitis

Article

Author: Asare-Werehene, Meshach ; Bohn, Mary Kathryn ; Selvaratnam, Rajeevan ; Ming-Freckleton, Allison

BACKGROUND:

Fecal calprotectin is a marker used to differentiate inflammatory bowel disease versus irritable bowel syndrome and is relevant in the diagnosis of ulcerative colitis and Crohn's disease. Markedly elevated calprotectin from stool samples provides evidence of colonic inflammation to support the diagnosis of pancolitis. This report is the first to demonstrate the clinical significance of fecal calprotectin in supporting the diagnosis of pancolitis induced by the anti-viral drug, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).

CASE REPORT:

A 62-year-old male on Biktarvy for his HIV diagnosis was admitted to internal medicine with abdominal pain, bloody diarrhea and pancolitis. His white blood cell count was 15.8 (4.0-11.0x10⁹/L), neutrophil count was 9.7 (2.0-7.5 × 10⁹/L), monocyte count was 1.2 (0.2-0.8 × 10⁹/L), granulocyte count was 1.5 (≤0.1 × 10⁹/L) and hemoglobin was 163 (140-180 g/L). The patient had a C-reactive protein of 229 (≤11.0 mg/L). Serology and blood culture were negative for microbial testing and abdomino-pelvic computed tomography findings were unremarkable. A bloody stool collected had a fecal calprotectin level of 1,159 (<50 µg/g).

CONCLUSIONS:

This case highlights how anti-retroviral therapies such as Biktarvy may elicit medication-induced gastrointestinal symptoms, which may underlie the cause of bloody diarrhea and pancolitis, and consequently a grossly elevated fecal calprotectin.

186

News (Medical) associated with Tenofovir Alafenamide Fumarate

12 Mar 2025

·pipelinereview.com

Gilead Presents New HIV Treatment and Cure Research Data at CROI 2025, Including an Investigational Long-Acting, Twice-Yearly Therapy Option

– Long-Term Outcomes Reinforce the High Efficacy of Biktarvy ® in People with HIV and HBV Coinfection – – Investigational Long-Acting, Twice-Yearly Treatment Regimen of Lenacapavir and Broadly Neutralizing Antibodies (bNAbs) Meets Primary Endpoint in Phase 2 Study and Gains Breakthrough Therapy Designation – – Late-Breaker Oral Presentation of Phase 2 Results from the First HIV Cure Clinical Trial Conducted in South Africa – FOSTER CITY, CA, USA I March 12, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of late-breaking data and multiple oral presentations from its innovative HIV treatment portfolio and pipeline at the Conference on Retroviruses and Opportunistic Infections (CROI 2025). The new findings reflect a transformative portfolio and a rapidly advancing forward-looking pipeline focused on expanding choices and enhancing outcomes for those with HIV, while continuing to reach towards a cure. “Gilead is fueling the next wave of innovation in HIV to help end the epidemic globally,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head. “Our contributions to CROI spotlight our dedication to scientific discovery, reflect our commitment to addressing the diverse treatment needs and preferences of communities affected by HIV and underscore the vital importance of catalyzing research reaching towards a cure.” Biktarvy Demonstrates High Rates of Viral Suppression in People with HIV/HBV Coinfection ALLIANCE ( NCT03547908 ) is an ongoing Phase 3 study evaluating Biktarvy versus dolutegravir 50 mg (DTG) + emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, F/TDF, DTG+F/TDF, in adults with HIV-1/HBV co-infection initiating treatment. The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV/HBV coinfection. Its goal is to evaluate treatment regimens that may effectively suppress both HIV and HBV. Previously reported results demonstrated the efficacy of both antiretroviral regimens. New outcomes were presented at CROI. Week 48 outcomes from the open-label extension phase following the 96-week randomized phase reported on the longer-term efficacy and safety of the investigational use of Biktarvy in adults with HIV/HBV coinfection initiating treatment. The newly presented data shows that Biktarvy maintained high rates of HIV-1 (95.4%) and HBV (86.6%) virologic suppression, defined as HIV RNA <50 copies/ mL and HBV DNA <29 IU/ mL, respectively, in participants (n=89) following a switch to Biktarvy after 96 weeks of treatment with DTG+ F/TDF. Study drug-related treatment-emergent adverse events (TEAEs) were reported in 19% of participants and most were mild to moderate, with zero discontinuations due to TEAEs. The most commonly reported study drug–related TEAEs were weight gain (9%) and low-density lipoprotein (LDL) cholesterol increased (3%). These data demonstrate the high rates of viral suppression by Biktarvy in adults with both HIV-1 and HBV switching their treatment to Biktarvy. The use of Biktarvy in individuals with HIV/HBV co-infection is investigational and the safety and efficacy of this use have not been established. Breakthrough Therapy Designation Awarded to Long-Acting, Twice-Yearly Investigational Treatment Combination Regimen of Lenacapavir and Broadly Neutralizing Antibodies (bNAbs) In January 2025, the FDA granted lenacapavir (LEN) with bNAbs (teropavimab [GS-5423, TAB] and zinlirvimab [GS-2872, ZAB]) Breakthrough Therapy Designation, which is intended to expedite the development of new drugs that may demonstrate substantial improvement over available therapy. LEN+TAB+ZAB (LTZ) harbors the potential to be the first long-acting combination treatment regimen with twice-yearly dosing. At CROI 2025, the primary results of a Phase 2 study evaluating the investigational combination of LTZ were presented during an oral session and featured in the press program; those data announced at CROI confirm previously presented Phase 1b results. The Phase 2 ( NCT05729568 ) open-label study from Gilead’s long-acting treatment pipeline evaluated the treatment response of participants receiving the investigational combination of LTZ. Efficacy and safety results were evaluated when virologically suppressed adults switched to LTZ every 6 months versus staying on stable baseline oral antiretroviral regimen. The study met its primary endpoint, which is the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 as determined by the US FDA-defined snapshot algorithm. The Week 26 data demonstrated the high efficacy of the LTZ regimen, with 96% (n=51 of 53) of participants who received LTZ and 96% (n=26 of 27) who received SBR remained virologically suppressed. CD4 cell counts also increased from baseline to week 26 in both groups, with a mean change of +23/μL (n=143) with LTZ and +69/μL (n=203) with SBR. The most common AEs with LTZ were injection site reactions related to subcutaneous LEN administration. There were no serious adverse events (AEs) related to LTZ; there were no infusion reactions related to TAB or ZAB. One participant in the SBR arm discontinued the study due to a serious treatment-related AE. Teropavimab and zinlirvimab are investigational compounds. The use of these compounds in combination with lenacapavir are investigational. They are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use, alone or in combination with lenacapavir. Their safety and efficacy are unknown. The use of lenacapavir in virologically suppressed people with HIV is investigational and the safety and efficacy of this use have not been established. Landmark HIV Cure Clinical Trial Conducted in South Africa Results from the first HIV cure trial to be conducted in South Africa, sponsored by Gilead, demonstrated that complex cure studies can be successfully conducted, alongside community, in resource-limited settings where great unmet need exists. As part of Gilead’s efforts to find a cure for HIV, the Phase 2a GS-US-382-5445 trial ( NCT05281510 ) enrolled 20 South African cisgender women from the FRESH (Females Rising through Education, Support, and Health) cohort who had received antiretroviral therapy (ART) soon after acquiring HIV and were virologically suppressed for at least 12 months. Participants received up to 10 oral doses of Gilead’s investigational TLR7 agonist, vesatolimod, every 2 weeks starting on day 0, plus IV infusions of broadly neutralizing antibodies (bNAbs) VRC07-523LS and CAP256V2LS, provided by the National Institutes of Health (NIH), on day 7. Participants began an analytical treatment interruption (ATI) on Day 35 and remained off ART until Week 48, or until they met restart criteria. Participants who reached week 48 without meeting ART restart criteria had the option of remaining off ART through the end of study follow-up at Week 60. Results presented at CROI showed the treatment combination was generally well-tolerated with no treatment-related serious adverse events (TEAEs) reported. The most common study TEAEs were infusion-related reactions (n = 18; 16 grade 1, 2 grade 2). Seventy percent of participants (n=14) met ART restart criteria. Thirty percent (n=6) remained off ART through Week 48, of which 4 remained off ART through Week 60. While the data suggest that the trial regimen alone is not sufficient as an HIV cure regimen, the mechanistic learnings will inform the development of future cure approaches. There is currently no cure for HIV or AIDS. Vesatolimod, VRC07-523LS and CAP256V2LS are investigational compounds. They are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use, alone or in combination. Their safety and efficacy are unknown. Please see below for U.S. Indications and Important Safety Information, including Boxed Warning , for Biktarvy. About Lenacapavir Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. Science Magazine named lenacapavir its 2024 “Breakthrough of the Year.” About Biktarvy Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir with the F/TAF backbone. Biktarvy is a complete STR and should not be taken with other HIV medicines. U.S. Indication for Biktarvy Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir. About Gilead HIV Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications , including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS. SOURCE: Gilead Sciences

Clinical ResultPhase 2Phase 3Drug ApprovalBreakthrough Therapy

12 Mar 2025

·endpts.com

Researchers make case against Gilead in HIV product hopping fight

Can Gilead be held accountable for holding back the sale of an HIV drug it allegedly knew was safer than its blockbuster predecessor? That’s the question before the California Supreme Court, and the answer could offer a unique example of a situation where a pharma company can be liable for a product that isn’t defective. Two academics from the University of West Virginia and Dartmouth wrote in a JAMA Viewpoint on Wednesday that there’s a strong case to be made against Gilead because it knew that the later product was safer and deliberately delayed the launch of that drug. The original lawsuit, filed in San Francisco by 24,000 AIDS patients, similarly alleges that Gilead slow-walked the safer HIV drug, known as tenofovir alafenamide fumarate (TAF), to maximize profits from an older HIV drug, tenofovir disoproxil fumarate (TDF). The company delayed entry of TAF while knowing that TAF had fewer serious bone and kidney side effects, the plaintiffs said. A California appeals court ruled in January 2024 that delaying TAF may make Gilead liable for negligence. The court said that the “legal duty of a manufacturer to exercise reasonable care can … extend beyond the duty not to market a defective product” and that the plaintiffs should be able to present the evidence to a jury. Gilead appealed to the California Supreme Court, which agreed last May to review the case. The case has yet to be scheduled for arguments. The California high court’s question is: “Does a drug manufacturer have a duty of reasonable care to users of a drug it is currently selling, which is not alleged to be defective, when making decisions about the commercialization of an allegedly safer, and at least equally effective, alternative drug?” Many major biopharmas back Gilead in the case. JAMA co-author Sean Tu of West Virginia, whose research is partially funded by Arnold Ventures, told Endpoints News that the question “essentially amounts to whether pharma companies can delay the commercialization of drugs that could be safer than currently marketed products.” He said PhRMA and other pharma companies are wrong to tout this case as a “duty to innovate” case, meaning that if Gilead loses, manufacturers would have a legal obligation to develop and market improved, or safer, alternative drugs, even if the existing product isn’t defective. “Gilead had a safer product in the works, but decided not to release it because they were afraid it would ‘cannibalize’ profits from the older (TDF) product,” Tu said. “What resulted? Probably thousands of patient deaths and tens of thousands of adverse serious events. But it also resulted in hundreds of millions of added revenues for Gilead.” The twists and turns of the lawsuit against Gilead also highlight the difficulties in compensating patients who have been harmed by pharmaceuticals, according to the JAMA Viewpoint. They coin the term “drug versioning” to explain what Gilead did, which the authors call a new form of product hopping. “Drug versioning occurs when a manufacturer delays a newer version of an existing product to maximize profits from an older one,” they write. But they also note that Gilead would be liable only for withholding a product that was already developed and planned for commercialization, not for failing to invent a safer version in the first place. “Gilead’s liability is predicated on its proven knowledge of TAF’s benefits, not its mere possession of positive Phase 1 and 2 results,” the authors write.

Patent Infringement

12 Mar 2025

·firstwordpharma.com

Merck & Co. moves closer to FDA filing for HIV therapy that maintains viral suppression

Merck & Co. is pushing forward with a simplified oral HIV treatment – a once-daily, two drug regimen that combines Pifeltro (doravirine) with its experimental nucleoside reverse transcriptase translocation inhibitor islatravir – aiming to file for regulatory approval by mid-2025.The announcement Wednesday follows positive data from two Phase III trials demonstrating that the regimen is just as effective as standard HIV therapies in maintaining viral suppression in adults with HIV-1. Merck first shared topline results in December and unveiled more detail at the Conference on Retroviruses and Opportunistic Infections (CROI) on Wednesday.In one of studies, called MK-8591A-052, the Pifeltro/islatravir combo was tested against Gilead Sciences' HIV treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) in 513 HIV patients who had virologic suppression for at least three months while on Biktarvy. At 48 weeks, 91.5% of patients who switched to Merck's regimen kept their viral load under control, compared to 94.2% of those on Biktarvy, meeting the bar for non-inferiority. Although the regimen did not achieve superiority over the Gilead's drug.The second trial, dubbed MK-8591A-051, compared Pifeltro/islatravir to patients' existing antiretroviral therapy (bART). Here, 95.6% of patients on Pifeltro/islatravir maintained viral suppression at 48 weeks, versus 91.9% seen in the bART group.If approved, Merck's treatment would be the first two-drug HIV regimen that doesn't include an integrase inhibitor to demonstrate comparable efficacy and safety to the three-drug InSTI-based Biktarvy regimen in a Phase III trial, according to Eliav Barr, chief medical officer at Merck Research Laboratories."These data and our work on the longer-acting islatravir-based therapies in our pipeline show our continued commitment to help find new options that address the evolving needs of people living with HIV," Barr added.The regimen's safety profile was generally comparable to the comparator antiretroviral regimens across both trials. At week 48, the mean percent change in total lymphocyte and CD4 counts were similar between Pifeltro/islatravir and comparator treatments, an issue that had stalled the programme a few years ago. There was also no treatment-emergent resistance to Pifeltro or islatravir in either trial.Beyond this daily oral combination, Merck is also advancing a once-weekly combination of islatravir with Gilead's capsid inhibitor lenacapavir, which showed positive Phase II results in October.

Clinical ResultPhase 3Phase 2

100 Deals associated with Tenofovir Alafenamide Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
D10605	Tenofovir Alafenamide Fumarate	J05AF13	DB09299

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Virus Diseases	China	Gilead Sciences Ireland UC	09 May 2019
Hepatitis B, Chronic	United States	Gilead Sciences, Inc.	10 Nov 2016
Liver Diseases	United States	Gilead Sciences, Inc.	10 Nov 2016
HIV Infections	Canada	Gilead Sciences Canada, Inc.	-

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Fatigue	Phase 2	United States	Gilead Sciences, Inc.	15 Sep 2022
Multiple Sclerosis, Relapsing-Remitting	Phase 2	United States	Gilead Sciences, Inc.	15 Sep 2022
Acquired Immunodeficiency Syndrome	Phase 2	United States	Gilead Sciences, Inc.	01 Apr 2019
Mitochondrial Cytopathy	Phase 2	United States	Gilead Sciences, Inc.	01 Apr 2019
Hepatitis B	Phase 1	United States	Gilead Sciences, Inc.	22 Dec 2014
Hepatitis B	Phase 1	Germany	Gilead Sciences, Inc.	22 Dec 2014
Hepatitis B	Phase 1	New Zealand	Gilead Sciences, Inc.	22 Dec 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03753074 (ATTENTION, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 4	Hepatitis B, Chronic	734	Tenofovir alafenamide 25 mg daily	gitsssnhma(aqjdlnqmht) = txvwqoybbn dxoecvwlos (amhstyqnhm )	Positive	01 Apr 2025
				tenofovir alafenamide (Observation)	gitsssnhma(aqjdlnqmht) = rowhxpuztu dxoecvwlos (amhstyqnhm )
NCT03920618 (Pubmed \| Liver Res)	Not Applicable	Acute-On-Chronic Liver Failure	199	Tenofovir alafenamide (TAF)	nasvkelutf(vqubkpwzym) = izkxcfgpht ggwmyiwbpz (qhtfojicdy ) View more	Positive	01 Dec 2024
				Tenofovir disoproxil fumarate (TDF)	nasvkelutf(vqubkpwzym) = rpcsrmbqqj ggwmyiwbpz (qhtfojicdy ) View more
NEWS Manual	Not Applicable	Hepatitis B, Chronic	130	TMF	oxtrsksktl(ydslsuyble) = jbdrumxnqj kuiawxitcs (yldtlpjdtj ) View more	Positive	18 Nov 2024
				TAF	oxtrsksktl(ydslsuyble) = ougzbtpkup kuiawxitcs (yldtlpjdtj ) View more
NCT04850950 (Pubmed \| Am J Gastroenterol)	Phase 4	Hepatitis B HBV DNA	239	Expected Eight-Week Prenatal Tenofovir Alafenamide Prophylaxis	agbwiglgwp(xmpjbwrfzu) = wmjujwnkmq gjebahuvyk (okyzffuovt, 4.5% - 11.1) View more	Positive	09 Oct 2024
				Expected Twelve-Week Perinatal Tenofovir Alafenamide Prophylaxis	bsbtxgwmpk(weofbhwupe) = axxgqsouhc zzhclkusae (gmysgqjteq )
NCT01940471 \| NCT01940341 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 3	Hepatitis B, Chronic	1,298	tenofovir alafenamide (TAF8y)5 mg/day	pamjhqjykv(xotpnengpj) = remained stable in patients receiving double-blind/OL TAF, with only small declines at year 8. Decreases in BMD observed during double-blind TDF improved after switching to OL TAF ydqpcleisg (ckzhmpuzsk )	Positive	27 Sep 2024
				Tenofovir disoproxil fumarate (TDF2y)00tenofovir alafenamide (TAF6y
NCT04937881 (PrEP-PP PK, CTgov)	Phase 3	HIV Infections	39	Tenofovir Alafenamide (TAF Arm)	kxoybkoykf(uybnuknyeh) = ffnlvztpsw jdtkpyqley (heyqqtfezj, cekblrhgow - himpohdehg) View more	-	03 Sep 2024
				Tenofovir Disoproxil Fumarate (TDF Arm)	kxoybkoykf(uybnuknyeh) = bmyxlzrvbw jdtkpyqley (heyqqtfezj, xkdrlbsrxr - rihqdgtnoa) View more
NCT03180619 (Pubmed)	Phase 2	Hepatitis B, Chronic \| Hepatic Insufficiency \| Renal Insufficiency	124	Tenofovir alafenamide 25 mg	edikdllhyw(asfaypvfrh) = occurred in 20 (22%) part A participants and in ten (32%) part B participants; none were related to treatment fglsnclitr (pbmdusebey ) View more	Positive	01 Aug 2024
NCT03695029 (Pubmed \| Liver Int) Manual	Phase 4	Hepatitis B	131	Tenofovir alafenamide (TAF)	opaxxyluxi(tnnzmopdkr) = acwipffzxo gzbkdqrwom (qprizsimkp ) View more	Positive	01 Jun 2024
				Tenofovir disoproxil fumarate (TDF)	opaxxyluxi(tnnzmopdkr) = tokbvbanse gzbkdqrwom (qprizsimkp ) View more
NCT03887702 (CTgov)	Phase 3	Hepatitis B \| Malignant Solid Neoplasm	4	Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 1 (TAF, TDF, Entecavir: Prophylactic))	nibarchusk(jczfblbldt) = vncrszbhpu hplcdbpact (nwfqgnklov, tobxfenpzg - cayvqkpbik) View more	-	20 May 2024
				Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 2 (TAF, TDF, Entecavir: Upon Indication))	nibarchusk(jczfblbldt) = vjzofmhqwe hplcdbpact (nwfqgnklov, evitnltosv - dvunxbqcwb) View more
DDW2024	Not Applicable	Hepatitis B, Chronic	-	Tenofovir Alafenamide (TAF)	epcraposgw(rffwnpbkxg) = wagzarjadw snndmawgwo (qaxhiiajdt )	-	18 May 2024
				Tenofovir Disoproxil Fumarate (TDF)	epcraposgw(rffwnpbkxg) = yvuwuojnbg snndmawgwo (qaxhiiajdt )

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