Delving into the Latest Updates on Tenofovir with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(R)-PMPA, Anhydrous tenofovir, Tenofovir (anh.)

+ [15]

Target

RT

Action

inhibitors

Mechanism

RT inhibitors(Viral reverse transcriptase inhibitors)

Therapeutic Areas

Infectious DiseasesImmune System DiseasesDigestive System Disorders+ [1]

Active Indication

Virus DiseasesHepatitis B, ChronicHIV Infections

Inactive Indication

DyspareuniaHepatitis B Virus-Related Hepatocellular CarcinomaHerpes Simplex+ [3]

Originator Organization

Gilead Sciences, Inc.

Active Organization

Gilead Sciences, Inc.

Pharmacare Srl

Lauren Sciences LLC

Inactive Organization

ViiV Healthcare Ltd.

GSK Plc

Contraception Research and Development

License Organization

International Partnership for Microbicides

Gilead Sciences, Inc.

Contraception Research and Development

Drug Highest PhaseApproved

First Approval Date

China (18 Jun 2008),

Virus Diseases

RegulationOrphan Drug (United States)

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Structure/Sequence

Molecular FormulaC9H16N5O5P

InChIKeyPINIEAOMWQJGBW-FYZOBXCZSA-N

CAS Registry206184-49-8

This study aims to evaluate the effect of long-term use of Tenofovir Disoproxil Fumarate (TDF) on bone density in patients with chronic hepatitis B virus (HBV) infection. Tenofovir is a widely used antiviral medication for the treatment of HBV. While it is generally well tolerated, some studies have reported potential adverse effects on bone mineral density, particularly with long-term use.
The objective of this research is to assess whether extended TDF therapy is associated with reduced bone density or increased risk of osteopenia or osteoporosis in adult patients with chronic HBV infection. The study will involve clinical evaluation and radiological assessment of bone health using dual-energy X-ray absorptiometry (DEXA) scans, as well as relevant biochemical markers.
This investigation will provide important data on the long-term safety profile of Tenofovir in relation to bone health and help guide future clinical decisions for the management of chronic hepatitis B.

Start Date22 May 2025

Sponsor / Collaborator

Assiut University

CTRI/2024/08/072599

/ RecruitingNot ApplicableIIT

A retrospective analysis of adherence rate and associated factors in a Tenofovir, Lamivudine, and Dolutegravir based regimen in People Living with HIV - NIL

Start Date27 Aug 2024

Sponsor / Collaborator-

ACTRN12623001202651

/ Not yet recruitingNot ApplicableIIT

Field trial in Vanuatu to assess the effectivess of treating-all pregnant women with hepatitis B with tenofovir prophylaxis to prevent mother-to-child transmission compared to guideline-based care

Start Date01 Mar 2024

Sponsor / Collaborator

The Macfarlane Burnet Institute For Medical Research & Public

100 Clinical Results associated with Tenofovir

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100 Translational Medicine associated with Tenofovir

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100 Patents (Medical) associated with Tenofovir

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6,403

Literatures (Medical) associated with Tenofovir

31 Dec 2025·HIV Research & Clinical Practice

Evaluating adherence in an active-controlled HIV pre-exposure prophylaxis trial (PrEPVacc) to inform the estimation of HIV incidence in a counterfactual placebo arm

Article

BACKGROUND:

Inferring the counterfactual placebo HIV incidence using the estimated effectiveness of Emtricitabine/Tenofovir (TDF/FTC) in active-controlled pre-exposure prophylaxis (PrEP) trials has been suggested. However, it has not yet been widely applied. In this article, we evaluate adherence to TDF/FTC in the PrEPVacc trial (NCT04066881) and consider how such adherence data could be used to estimate the effectiveness of TDF/FTC and subsequently, HIV incidence in a counterfactual placebo arm in a predominantly female population.

METHODS:

From December 2020 to March 2023 participants were recruited into the trial which included a comparison of Emtricitabine/Tenofovir Alafenamide (TAF/FTC) to TDF/FTC as PrEP over 26 weeks of follow-up, in Uganda, Tanzania, and South Africa. PrEP adherence was assessed in various ways.

RESULTS:

Of 697 participants dispensed TDF/FTC, 87% were female, 54% were ≥ 25 years, and 59% were sex workers. In a random sample (41%) assessed at visit 6 (week 8), 76% had detectable TFV-DP levels, with 22% reaching levels consistent with ≥2 pills/week. Males, Verulam and Mbeya participants, those ≥ 25 years, not single, subsistence fisheries workers, and those who had any STI at baseline were more likely to have higher adherence. Of those assessed at visit 6, 29% were identified as white coat dosing. Estimated (crude) HIV incidence risk reduction ranged from 10% to 65%.

CONCLUSIONS:

TDF/FTC adherence in the PrEPVacc trial was low, with considerable levels of white coat dosing. Inferring the counterfactual placebo HIV incidence using the estimated effectiveness of TDF/FTC is a promising approach, however, the approach requires further elaboration and evaluation.

31 Dec 2025·Global Health Action

Low-level viremia in people with HIV in Ethiopia is associated with subsequent lack of viral suppression and attrition from care

Article

Author: Abdissa, Alemseged ; Björkman, Per ; Abdulahi, Ilili Jemal ; Reepalu, Anton ; Elvstam, Olof ; Medstrand, Patrik

BACKGROUND:

Low-level viremia during antiretroviral therapy (ART) has been associated with inferior outcomes, but knowledge on the impact of low-level viremia in the current era of dolutegravir-based ART in low-income countries is limited.

OBJECTIVE:

To investigate whether low-level viremia predicts virologic non-suppression and attrition from care in people with HIV receiving ART in Ethiopia.

METHODS:

We included people receiving ART at public health facilities in an urban area in central Ethiopia and categorized persons with ≥1 available viral load 2019-2020 as having either suppression (<150 copies/mL) or low-level viremia (151-1,000 copies/mL); people with >1,000 copies/mL were excluded. We used multivariable logistic regression adjusted for age, sex, ART regimen, type of health facility, and duration of ART to analyze the associations between viremia category and incidence of unsuppressed viral load (>1,000 copies/mL) and attrition from care (death or loss to follow-up) during 3 years of follow-up.

RESULTS:

Among 12,165 participants, the median age was 44 years, 64.2% were female, and 89.1% received tenofovir/lamivudine/dolutegravir. Of the study population, 11,959 (98.3%) had suppression and 206 (1.7%) had low-level viremia. Over 3 years of follow-up, 2.2% of participants with suppression and 11.3% with low-level viremia had unsuppressed viral load. Low-level viremia was associated with both unsuppressed viremia (adjusted odds ratio [aOR], 3.7; 95% confidence interval [CI], 2.2-6.2) and attrition (aOR, 3.4; 95% CI, 1.7-6.6).

CONCLUSION:

Among Ethiopian people with HIV receiving ART, low-level viremia predicted subsequent virologic non-suppression and attrition from care, supporting current recommendations for heightened attention to low-level viremia in ART recipients.

01 Sep 2025·Journal of Virus Eradication

HIV PrEP programmes as a framework for diagnosing and treating HBV infection in adolescents and young adults in KwaZulu-Natal, South Africa

Article

Author: Dreyer, Jaco ; Busang, Jacob ; Sukali, Gloria ; Anderson, Motswedi ; Iwuji, Collins ; Waddilove, Elizabeth ; Upton, Janine ; Delphin, Marion ; Okesola, Nonhlanhla ; Herbst, Carina ; Seeley, Janet ; Shahmanesh, Maryam ; Khoza, Thandeka ; Matthews, Philippa C

Background:

Guidelines for Hepatitis B treatment released by the World Health Organization in 2024 include the potential for use of dual therapy, combining tenofovir with either emtricitabine or lamivudine. These fixed-dose combinations are also used for Pre-Exposure Prophylaxis (PrEP) in people at risk of Human Immunodeficiency Virus (HIV). We hypothesize that pre-existing HIV PrEP programmes can support access to HBV testing and treatment.

Methods:

At the Africa Health Research Institute (AHRI) in KwaZulu Natal, South Africa, we evaluated PrEP uptake and retention amongst adolescents and young adults aged 15-30 years. We reviewed HBV status, acceptance of PrEP and retention in follow-up between June 2022-Sept 2024.

Results:

15847 adolescents and young adults received an assessment in the community, of whom 3481/15847 (21.9 %) were eligible for sexual health prevention interventions. 3431/3481 (98.6 %) accepted HBV screening, of whom 21/3431 (0.6 %) tested positive for HBsAg. These 21 individuals had not previously been aware of their HBV status, but one was already on antiretroviral therapy for HIV infection. Amongst the others, 16/20 (80 %) were considered eligible for PrEP, and 15/16 started PrEP. When investigating retention in care, among 15 individuals due for a refill, 8/15 (53.3 %) returned at least once.

Conclusion:

Sexual reproductive health and PrEP programmes provide an opportunity for HBV testing and treatment. However, attrition from the care cascade at each step highlights the pressing need for interventions that address barriers to sustainable delivery of long-term care.

125

News (Medical) associated with Tenofovir

14 Jul 2025

·www.fiercebiotech.com

Merck wades deeper into HIV PrEP waters dominated by Gilead with 2 new late-stage trials

Merck is betting that its once-monthly pill will provide an alternative to Gilead\'s twice-yearly lenacapavir injection, which has been hailed as a scientific breakthrough.\n Even with the HIV prevention waters now dominated by Gilead Science’s Yeztugo (lenacapavir), Merck & Co. is not afraid to swim deeper in. The New Jersey pharma is teaming up with the Gates Foundation to launch a pair of phase 3 trials of its once-monthly, oral pre-exposure prophylaxis (PrEP) prospect.The EXPrESSIVE-10 trial will begin enrolling women and girls across 31 sites in Kenya, South Africa and Uganda within the next few months, Merck said in a July 14 release. Another trial, EXPrESSIVE-11, will start enrolling sexually active people from 16 countries in August. Both trials aim to enroll around 4,400 people and will test whether Merck’s MK-8527 reduces the incidence of HIV compared to Gilead’s daily PrEP pill Truvada (emtricitabine/tenofovir).The Gates Foundation is providing grant funding to the International Clinical Research Center (ICRC) at the University of Washington and the University of Alabama at Birmingham to support EXPrESSIVE-10, according to the release, with the money going towards a community advisory group, patient recruitment and retention materials, while also supporting ICRC’s partnership with the trial sites.The nonprofit is also providing funds for a community advisory group, patient recruitment and retention materials for EXPrESSIVE-11. MK-8527 inhibits the reverse transcriptase enzyme that HIV uses to replicate, according to the release. The Big Pharma recently wrapped up a phase 2 trial of the asset, which revealed similar rates of adverse events between the treatment and placebo arms. The company plans to share more data from the study at the AIDS Society Conference on HIV Science in Rwanda on July 16.The public health world has been abuzz about Gilead’s twice-yearly lenacapavir injection, which was approved as Yeztugo on June 19 and has been hailed as a scientific breakthrough. An HIV physician told Mizuho Securities that she expects most of her patients to switch to Yeztugo within the next year, with the pharma projecting a peak sales potential of $8 billion per year for the drug. For MK-8527, Merck is betting that there will be a robust market of people seeking PrEP who prefer oral meds to needles.“Scientific advances against HIV have brought us further than ever imagined and are ushering in a new era in HIV prevention,” Trevor Mundel, Ph.D., president of global health at the Gates Foundation, said in the release. “With only 18% of global PrEP need currently met, there is a clear and urgent need for options like MK-8527 that may offer the ability to prevent infection. These phase 3 trials are a key step toward translating progress into longer-acting options that could help turn the tide on HIV.”The World Health Organization updated its HIV prevention guidelines on July 14 to recommend Yeztugo, with Director-General Tedros Adhanom Ghebreyesus, Ph.D., calling lenacapavir the “next best thing” in the absence of an HIV vaccine.

Phase 2Phase 3Drug Approval

14 Jul 2025

·firstwordpharma.com

Merck & Co. moves once-monthly HIV prevention pill into Phase III

Merck & Co. is diving into the next generation of HIV prevention with a once-a-month pill, entering late-stage trials just weeks after Gilead Sciences' long-acting injection won FDA approval. The move potentially sets up a nascent rivalry between different dosing approaches, with Merck's contender, MK-8527, potentially offering an alternative, non-injectable option for pre-exposure prophylaxis (PrEP).The decision to advance MK-8527, a nucleoside reverse transcriptase translocation inhibitor, was supported by a Phase II study involving 350 adults ages 18 through 65. The trial showed similar adverse event rates between the drug and placebo groups, with no clinically meaningful changes in laboratory tests including total lymphocyte and CD4 T-cell counts. Moreover, Merck said pharmacokinetics data from the study, to be detailed in a late-breaker presentation Wednesday at the International AIDS Society (IAS) conference, demonstrated that both MK-8527 and its active form MK-8527-TP support once-monthly dosing for prevention.The new Phase III EXPrESSIVE programme includes two large-scale trials. EXPrESSIVE-11 will enroll 4390 sexually active people across 16 countries beginning in August, comparing MK-8527 to daily treatment with Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate). EXPrESSIVE-10, conducted in partnership with the Gates Foundation, will focus on 4580 women ages 16 to 30 in Kenya, South Africa and Uganda, with enrollment starting "in the next few months," according to Merck."With only 18% of global PrEP need currently met, there is a clear and urgent need for options like MK-8527 that may offer the ability to prevent infection," said Trevor Mundel, president of global health at the Gates Foundation, in a release Monday.The entry of MK-8527 into Phase III comes on the heels of what Gilead CEO Daniel O'Day described as the "historic" FDA approval of the company's long-acting HIV-1 capsid inhibitor Yeztugo (lenacapavir) last month. The twice-yearly injection demonstrated near-complete protection in clinical trials, with no HIV infections reported in one study and just two cases among 2180 participants in another.Early feedback suggests strong enthusiasm for the longer-acting option. The World Health Organization (WHO) on Monday recommended the use of Yeztugo as a "powerful tool" to prevent HIV infections. Plus, results from a recent FirstWord physician poll showed that 89% of respondents expect Yeztugo's twice-yearly dosing to improve patient adherence and satisfaction compared to current alternatives. For more, see – Physician Views Results: Doctors say 'yes' to Yeztugo's twice-yearly promise in HIV PrEP.Merck's HIV pipeline also includes a revitalised effort around islatravir — which, like MK-8527, is also a nucleoside reverse transcriptase translocation inhibitor. The drug faced setbacks a few years ago due to safety concerns, but after pausing development in 2021 over drops in immune cell counts, Merck resumed progress with a simplified once-daily regimen combining islatravir and Pifeltro (doravirine). The FDA last week accepted a marketing application for the two-drug regimen, setting a target decision date for April 28 of next year.

Phase 3Clinical ResultPhase 2Drug Approval

14 Jul 2025

·www.pharmaceutical-technology.com

FDA to review MSD’s doravirine/islatravir NDA for HIV-1

Islatravir disrupts HIV-1 replication through several mechanisms. Credit: ktsdesign/Shutterstock. The US Food and Drug Administration (FDA) has accepted MSD’s doravirine/islatravir (DOR/ISL) new drug application (NDA) for review to treat adults with virologically suppressed human immunodeficiency virus (HIV)-1. A target action date of 28 April 2026 has been set under the Prescription Drug User Fee Act (PDUFA). The NDA for the once-daily oral regimen is supported by week 48 data from two Phase III trials, MK-8591A-051 and MK-8591A-052. In these studies, DOR/ISL proved non-inferior to both baseline antiretroviral therapy (bART) in trial MK-8591A-051 and to bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF (50mg/200mg/25mg)] in the double-blind trial MK-8591A-052. DOR/ISL demonstrated a safety profile generally comparable to that of comparator baseline antiretroviral regimens in MK-8591A-051 and BIC/FTC/TAF in MK-8591A-052. MSD Research Laboratories global clinical development senior vice-president and head, chief medical officer Dr Eliav Barr stated: “MSD has been at the forefront of HIV research for more than 35 years and we are pleased to continue our work to innovate and deliver new options that aim to meet the needs of the HIV community. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “The health needs of people living with HIV often change over time – whether it’s managing comorbidities or navigating complex medication regimens. We believe DOR/ISL, if approved, will represent an important new complete regimen option designed to help meet their diverse needs.” Islatravir (MK-8591) is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) that disrupts HIV-1 replication through several mechanisms. It inhibits the translocation of reverse transcriptase, leading to immediate chain termination. Additionally, it induces structural changes in the viral DNA, which contribute to delayed chain termination. In early July 2025, MSD agreed to purchase Verona Pharma in a transaction worth $10bn . The deal will strengthen MSD’s cardio-pulmonary product lineup by incorporating Ohtuvayre (ensifentrine), approved by the FDA for treating chronic obstructive pulmonary disease in adults. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now

Phase 3Clinical ResultDrug ApprovalAcquisitionNDA

100 Deals associated with Tenofovir

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External Link

KEGG	Wiki	ATC	Drug Bank
D06074	Tenofovir	J05AF07	DB14126

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Virus Diseases	China	Pharmacare Srl	18 Jun 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B Virus-Related Hepatocellular Carcinoma	Phase 3	Taiwan Province	Gilead Sciences, Inc.	01 Sep 2012
Hepatitis B, Chronic	Phase 3	Taiwan Province	Gilead Sciences, Inc.	01 Sep 2012
Herpes Simplex	Phase 3	South Africa	Contraception Research and Development	01 Oct 2011
HIV Infections	Phase 3	Belgium	ViiV Healthcare Ltd.	16 Jul 2002
HIV Infections	Phase 3	Canada	ViiV Healthcare Ltd.	16 Jul 2002
HIV Infections	Phase 3	France	ViiV Healthcare Ltd.	16 Jul 2002
HIV Infections	Phase 3	Germany	ViiV Healthcare Ltd.	16 Jul 2002
HIV Infections	Phase 3	Italy	ViiV Healthcare Ltd.	16 Jul 2002
HIV Infections	Phase 3	Portugal	ViiV Healthcare Ltd.	16 Jul 2002
HIV Infections	Phase 3	Spain	ViiV Healthcare Ltd.	16 Jul 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04686279 (ATN 163, Pubmed \| J Infect Dis)	Phase 1	HIV-negative	8	Tenofovir Rectal Microbicide Douche	dieeknqmyr(uyqazdenef) = Five mild to moderate AEs (e.g., nausea, hyperglycemia) were reported, none related to the product uuosivemzn (ggurlpmzoy )	Positive	28 Jun 2025
NCT03670355 (MTN-038, Pubmed \| J Int AIDS Soc)	Phase 1	HIV Infections TFV concentrations	49	Tenofovir Vaginal Ring	lmpumswhpt(lqmivoqzwb) = hsraxtkswb uempjdirwb (ppfrqvweyx ) View more	Positive	01 Mar 2024
				Placebo Vaginal Ring	lmpumswhpt(lqmivoqzwb) = pctpvgrjmk uempjdirwb (ppfrqvweyx ) View more
Pubmed \| J Int AIDS Soc	Not Applicable	HIV Infections	-	PrEP (Usual clinic flow)	vhjnspapvv(cnejrtimef) = avzzynahvh kraufmlwdd (ykzjaqqfmd ) View more	-	01 Mar 2024
NCT04686279 (ATN 163, CTgov)	Phase 1	Acquired Immunodeficiency Syndrome	8	Tenofovir Douche	yacbwxaydx(fzjmynhdao) = qfeuzfzszu exxfbsarof (oklrdgmire, qxaqrgxsde - bdsaeyqurq) View more	-	30 Oct 2023
NCT03917420 (CTgov)	Phase 1	Acquired Immunodeficiency Syndrome	10	Tenofovir 300Mg Oral Tablet+Emtricitabine 200 MG	hmcpupvrkq(ssqlqkpkzs) = kopmfjejxu dmqykzddep (ypavhqaoba, 819.0428) View more	-	12 Apr 2023
NCT01369212 (Pubmed \| Am J Gastroenterol)	Not Applicable	Hepatitis B, Chronic	201	Tenofovir disoproxil fumarate (TDF) + Peginterferon (PegIFN) alfa-2a	rnxjsxvqkp(tkfkwfsahg) = gtwgpzrawe qkwgawtsfs (ombbtbwsia )	-	05 Jan 2023
				Tenofovir disoproxil fumarate (TDF) alone	rnxjsxvqkp(tkfkwfsahg) = luuesfgjdg qkwgawtsfs (ombbtbwsia )
NCT01369212 (HBRN \| Hepatitis B Research Network Immune-Active Trial, CTgov)	Phase 3	Hepatitis B, Chronic	201	Tenofovir (Tenofovir)	qxfofepxnb = zahrwyywrc ucfmzdpfls (ouauhstqzv, rtscmtumyi - ilimdpuaov) View more	-	12 Oct 2022
				tenofovir+Pegasys (Peginterferon-alfa 2a and Tenofovir)	qxfofepxnb = hfkyhygrjk ucfmzdpfls (ouauhstqzv, nkbczgxxii - fkfbyirfet) View more
Pubmed Manual	Phase 4	HIV Infections	229	Dolutegravir+Lamivudine+Tenofovir Disoproxil Fumarate	jiezyibaur(dyrfkulkgm) = 389 AEs were reported from 58% of patients. Of these, 61 were related to study treatment. hjdbodzfkn (qybevabzpr ) View more	Positive	10 Aug 2022
NCT03988452 (NADIA, Pubmed \| Lancet HIV)	Phase 3	HIV Infections Second line	465	Dolutegravir	paptycctdy(kspfolqiwy) = rbvwequzck qzrfkpmqks (xjtpyazpeo )	Positive	20 Apr 2022
				Ritonavir-boosted darunavir	paptycctdy(kspfolqiwy) = xgejgyztzs qzrfkpmqks (xjtpyazpeo )
NCT02722343 \| NCT02904369 (Pubmed \| J Acquir Immune Defic Syndr)	Phase 1	HIV Infections	22	TDF/FTC oral tablets	artulddpnf(ecmhuiintk) = Adverse events (AEs) were more common with oral TDF/FTC use (P < 0.01) bmxzwelnqq (jocwegobvk )	-	01 Jan 2022
				TFV intravaginal ring