The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.
The primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.

Start Date17 Mar 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

NCT07390409

/ Not yet recruitingNot ApplicableIIT

ALIGN: A Non-randomised Study Delivering Injectable Lenacapavir for HIV Prevention Within a Pre-exposure Prophylaxis (PrEP) Choice Context in Cape Town, South Africa.

The ALIGN study will evaluate the delivery of injectable Lenacapavir (LEN), a long-acting injectable formulation for HIV pre-exposure prophylaxis (PrEP), amongst adolescents and young people (aged 15-35 years) living within the Klipfontein-Mitchell's health sub-district of Cape Town, South Africa. LEN will be offered alongside injectable Cabotegravir long-acting (CAB LA), an injectable PrEP product already approved for use in South Africa, and oral PrEP (F/TDF) modalities (including intermittent dosing where appropriate), the current standard of care (SOC) biomedical HIV prevention in South Africa. Following counselling, participants will be able to choose which PrEP product (LEN, CAB LA, or oral PrEP) to initiate, with the option to switch at any future clinical visit, and followed for 18 months. These options will be offered from two types of delivery sites, namely public health facilities and established mobile service delivery trucks, where various forms of PrEP are currently delivered as part of outreach services and ongoing research studies (FastPrEP UCT HREC nr. 713/2021 and PrEPared to Choose 567/2023).
Lenacapavir (LEN) is a novel, first-in-class, multi-stage HIV-1 capsid inhibitor with high potency and a long half-life, allowing administration by subcutaneous injection twice yearly (1). The PURPOSE 1 study, a phase 3, double-blind, randomized, controlled trial involved adolescent girls and young women in South Africa and Uganda. Purpose 1 study found that none of the participants receiving twice-yearly LEN injection acquired HIV infection (1). Purpose 2, which was conducted amongst cisgender men who have sex with men, transgender, and non-binary populations, reported two incident infections amongst 2179 LEN users. CAB LA is an alternative long-acting injectable formulation administered by intra-muscular injection every two months. CAB LA efficacy and safety was established in the HPTN 083 and HPTN 084 studies, which indicated a 66% and 88% reduction in HIV risk compared to oral PrEP users respectively. The ongoing PrEPared to Choose study, conducted by this study team, (UCT HREC 567/2023) offers CAB LA and oral PrEP products and has demonstrated the feasibility and impact of many of the PrEP choice and delivery processes put forward in this protocol. As such, this study team has extensive experience in CAB LA and oral PrEP real-world delivery.
The ALIGN study will provide one of the first real-world (outside of the clinical trial research site) evaluations of LEN delivery with the view to evaluate firstly, what implementation strategies best support LEN initiation and persistence at the level of the PrEP provider and the PrEP user, and secondly, persistence (defined as consistent, uninterrupted use as prescribed) on LEN compared to alternative injectable products and SOC oral PrEP. The proposed study will utilise a hybrid implementation study design, with co-primary implementation and clinical aims, in the form of a non-randomised, quasi-experimental trial design. Findings from this study will be used to inform the anticipated LEN rollout into public health facilities (including ANC clinics) as well as the implementation of PrEP choice service delivery in a new era of expanded biomedical HIV prevention products. The addition of LEN will build on the experiences of implementing previous long-acting PrEP products (such as injectable long-acting Cabotegravir) and will generate practical insights to inform the scale of this innovative tool while national regulatory approvals are being sought. This will include working with communities to harness their insights and answering specific questions to support effective delivery and drive uptake and effective use of injectable PrEP (LEN and CAB LA).
Study purpose:
To evaluate the delivery strategies (public health facility and community-based) and potential impact of Lenacapavir (LEN) as PrEP, on the relative persistence of up to 3700 young people (aged 15-35 years) initiating on LEN compared to an alternative injectable product (CAB LA) and oral PrEP products (standard of care).
We hypothesize that people who select injectable PrEP will be more likely to persist on PrEP when compared with people who select oral PrEP, and further that injectable LEN will show enhanced persistence compared to injectable CAB LA.
Primary study objectives:
The primary objectives of this study are to distinguish PrEP persistence patterns across different PrEP modalities (oral PrEP vs injectable CAB vs injectable LEN as PrEP) and identify successful implementation strategies that will aid the provision of PrEP choice to adolescents and young people in South Africa from two distinct delivery platforms (public health facilities and mobile services).

Start Date29 Jan 2026

Sponsor / Collaborator

Desmond Tutu Hiv Foundation

[+3]

NCT07044297

/ RecruitingPhase 3

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.
The goals of this study are to learn:
* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day
* About the safety of MK-8527 and if people tolerate it

Start Date31 Jul 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Emtricitabine/Tenofovir Disoproxil Fumarate

100 Translational Medicine associated with Emtricitabine/Tenofovir Disoproxil Fumarate

100 Patents (Medical) associated with Emtricitabine/Tenofovir Disoproxil Fumarate

345

Literatures (Medical) associated with Emtricitabine/Tenofovir Disoproxil Fumarate

01 Mar 2026·Lancet HIV

Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trial

Article

Author: Balkus, Jennifer ; McClure, Tara ; Hillier, Sharon L ; Nakabiito, Clemensia ; Stoner, Marie ; Mgodi, Nyaradzo M ; Mabuza, Carlotta ; Dadabhai, Sufia ; Gadama, Luis ; Chakhtoura, Nahida ; Piper, Jeanna M ; Hawley, Imogen ; Rossi, Lisa ; Rooney, James F ; Mayo, Ashley J ; Mhlanga, Felix G ; Anderson, Peter L ; Noguchi, Lisa ; Chappell, Catherine ; Balan, Ivan ; Kemel, Lena ; Scheckter, Rachel ; Davis, Jontraye ; Fairlie, Lee ; Livant, Edward ; Levy, Lisa ; Song, Mei ; Richardson, Barbra A ; Makanani, Bonus ; Manalo, Maricel ; Fowler, Mary Glenn ; Blanchette, Cheryl ; Musara, Petina ; Katz, Ariana ; Rosenberg, Zeda ; van der Straten, Ariane ; Szydlo, Daniel W ; Cleland, Naana ; Bunge, Katherine ; Brown, Amanda ; Chirenje, Z. Mike ; Singh, Devika ; Duran, Luis ; Young, Alinda ; Johnson, Abraham ; Taha, Taha E ; Harrell, Tanya ; Beigi, Richard H. ; Rausch, Dianne M ; Gous, Hermien ; Montgomery, Elizabeth ; Richardson, Barbra ; Senn, Teri ; Hendrix, Craig ; Gadama, Luis A ; Black, Roberta ; Marzinke, Mark A ; Riddler, Sharon A ; Seyama, Linly

BACKGROUND:

Pregnant women are at a four times higher risk of HIV per coital act than non-pregnant women. MTN-042/DELIVER was a phase 3b randomised study of dapivirine vaginal ring (DVR) and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate-emtricitabine to assess safety, adherence, and acceptability when used during pregnancy. Our hypothesis was that both DVR and oral PrEP would be safe and well tolerated when started early in the second trimester and continued until delivery.

METHODS:

In MTN-042/DELIVER, an open-label, phase 3b randomised trial, healthy pregnant women without HIV and aged 18-40 years from Malawi, South Africa, Uganda, and Zimbabwe were enrolled and randomly allocated (4:1) to open-label monthly DVR PrEP or daily oral PrEP. Women were enrolled between 12 weeks' and 29 weeks' gestation. Product use continued until delivery or 42 weeks' gestation. The primary outcomes for safety following exposure to study product were a composite of all serious adverse events, including maternal deaths, all grade 3 or higher adverse events, and pregnancy outcomes stratified as term (≥37⁺⁰ weeks), preterm (<37⁺⁰ weeks), and pregnancy loss before 20 weeks' gestation. Pregnancy complications and adverse events were summarised with descriptive statistics. This study is registered with ClinicalTrials.gov, NCT03965923.

FINDINGS:

Between July 12, 2022, and Jan 12, 2023, 251 mothers were enrolled, with 202 randomly allocated to receive DVR PrEP and 49 to receive oral PrEP. The median age was 24·0 years (IQR 22·0-29·0) and the median gestational age was 23·7 weeks (19·9-26·3). 28 mothers (11%) had safety events under the composite study primary outcome (all serious adverse events plus all grade 3 or higher adverse events), none of which was related to product use. No maternal deaths or HIV seroconversions occurred. There were 247 pregnancy outcomes of which 233 (94%) were at term (≥37⁺⁰ weeks). Pregnancy complications were uncommon, and none was infectious.

INTERPRETATION:

Adverse pregnancy outcomes related to DVR and oral PrEP use were uncommon among women starting PrEP in the second trimester. These findings support the use of these preventive approaches during pregnancy.

FUNDING:

US National Institutes of Health.

01 Mar 2026·EUROPEAN JOURNAL OF CANCER

Current treatment strategies for first relapse of high-risk neuroblastoma

Review

Author: Tweddle, Deborah A ; Thole-Kliesch, Theresa M ; George, Sally L ; Simon, Thorsten ; Beck-Popovic, Maja ; Rubio-San-Simón, Alba ; Flaadt, Tim ; Berlanga, Pablo ; Fischer, Matthias ; Chesler, Louis ; Corbacioglu, Selim ; Lang, Peter ; Schulze, Franziska ; Moreno, Lucas ; Castelli, Sveva ; Hero, Barbara ; Gray, Juliet C ; Molenaar, Jan J ; Gambart, Marion ; Astrahantseff, Kathy ; Barone, Giuseppe ; Künkele, Annette ; Schleiermacher, Gudrun ; Lode, Holger N ; Eggert, Angelika ; Owens, Cormac ; Deubzer, Hedwig E ; Schulte, Johannes H ; Rosswog, Carolina

More than 50 % of patients with high-risk neuroblastoma (HRNB) will relapse despite intensive multimodal therapy. Most relapses occur within 2 years of diagnosis. Overall survival at relapse is 20 % at 4 years, but long-term survival can be achieved in a patient subset. A biopsy at relapse with in-depth molecular characterization should now become accepted as standard of care to confirm active neuroblastoma and identify potential targets for biomarker-based targeted therapy or immunotherapy. No clear consensus currently exists about optimal therapy because the field lacks umbrella trials covering all phases of relapse treatment (re-induction, consolidation, maintenance) in a homogenous strategy. Recruitment into clinical trials (e.g. BEACON2) should be prioritized. Current evidence supports starting re-induction therapy with a camptothecin-based chemotherapy regimen combined with monoclonal antibody therapy targeting GD2 or VEGF (or ALK inhibitors if ALK-aberrant) as the first choice. The RIST regimen is a promising first choice for MYCN-amplified disease. After an objective response to re-induction therapy, GD2-directed immunotherapy or cellular therapies harnessing the immune system (haploidentical stem cell transplantation, CAR T cells) are of high interest as a consolidation strategy. Long-term maintenance therapy must be feasible as outpatient treatment, have a low toxicity profile and be well-tolerable to suit patients with relapsed HRNB. For optimal care, new options must be tested as maintenance therapy in randomized trials. The most promising salvage options for patients responding insufficiently to treatment are the chemotherapy combinations, topotecan/vincristine/doxorubicin (TVD), topotecan/cyclophosphamide/etoposide (TCE), ifosfamide/carboplatin/etoposide (ICE) or topotecan/cyclophosphamide (TopoCy), or [¹³¹I]-mIBG therapy. Early-phase clinical trials are also a possible option in this setting.

01 Feb 2026·AIDS AND BEHAVIOR

Gay Community Connectedness, Internalized Homonegativity, and HIV Pre-Exposure Prophylaxis (PrEP) Attitudes and Use Among Men Who Have Sex with Men in Georgia: A Mediation Analysis

Article

Author: Wang, Liyuan ; Haider, Mohammad Rifat ; Khan, Md Sharful Islam ; Hansen, Nathan ; Gibbs, Jeremy J ; Brown, Monique J ; Sarwar, Golam

Abstract:

Georgia has one of the highest HIV diagnosis rates in the U.S., yet only 33% of Pre-Exposure Prophylaxis (PrEP) users in the Deep South live there. This study aims to determine the potential mediational role of internalized homonegativity and attitudes towards PrEP between gay community connectedness and PrEP use among men who have sex with men (MSM) living in Georgia. Participants ( N = 121) completed an online survey in June 2020. PrEP use (yes/no) was defined by the question “the last time you had sex, were you taking PrEP, like Truvada?” The study also used the “8-item Identification and Involvement with the Gay Community scale”, “9-item internalized homophobia scale”, and a “3-item PrEP attitude scale”. Path analysis was performed using Stata 17.0. After adjusting for sociodemographic characteristics, positive associations were observed between attitudes towards PrEP and PrEP use (β = 0.11; p = < 0.001), and gay community connectedness (GCC) and PrEP attitudes (β = 0.17, p < 0.001). Conversely, negative associations were found between GCC and internalized homonegativity (β=−0.71, p < 0.001), and internalized homonegativity and PrEP use (β=−.01, p = 0.031). GCC was not significantly associated with PrEP use (β=−.01; p = 0.196). However, the indirect effects of GCC on PrEP use through PrEP attitudes (β = 0.01, p < 0.001) and internalized homonegativity (β = 0.02, p = 0.041) were statistically significant. These findings indicate that PrEP attitudes and internalized homonegativity mediate the relationship between GCC and PrEP use among MSM. Thus, improving attitudes toward PrEP and reducing internalized homonegativity through fostering GCC among MSM may improve PrEP use and persistence.

145

News (Medical) associated with Emtricitabine/Tenofovir Disoproxil Fumarate

08 May 2026

·www.fiercepharma.com

Gilead cranks up Yeztugo first-year sales forecast to $1B on 'unprecedented launch trajectory'

The California-based drugmaker expects its HIV sales to rise 8% in 2026. When Gilead Sciences rolled out its first sales projections for twice-yearly pre-exposure prophylaxis (PrEP) med Yeztugo (lenacapivir) at the start of this year, analysts dubbed the company’s $800 million outlook “probably” conservative and “quite doable.”Now, after gaining greater clarity on Yeztugo’s launch dynamics over the past few months, the company has edited its forecast to stand behind the billion-dollar opportunity that the drug holds in 2026. Over the first quarter, the long-acting injectable locked down $166 million in sales, an “unprecedented launch trajectory” that is so far “exceeding our expectations,” chief commercial officer Johanna Mercier laid out on the company’s first-quarter earnings conference call. In its first full year on the market, Gilead now expects $1 billion to come from the drug, while the next few years should see a “steady and durable build in sales” as the company looks to broaden adoption across the full slate of those who need HIV prevention options. Within the long-acting injectable market, Yeztugo’s main competition is with GSK’s Apretude, an every-two-month injection that launched years before Yeztugo hit the scene. Already, Yeztugo and its longer protection period is taking away market share from the GSK offering. Other than those who switch from Apretude, PrEP users are also switching from generics of Gilead’s Truvada and its older PrEP Descovy, Mercier explained on the call. While Yeztugo’s largest market currently comes from those switching from other PrEP options, Gilead is seeing “growing momentum in” in the drug among those who are naïve to PrEP, the company said in its presentation (PDF). As Mercier explains, there remains a “high unmet need” for PrEP in several areas of the country, such as the rural south, where Gilead sees “more of the naïve prescriptions” emerging thus far. One way to reach these potential PrEP users is through its direct-to-consumer campaign for Yeztugo, which launched in late February. The marketing has pushed brand awareness and visibility on the upswing, Mercier said, and also helps remind people to come back for their second dose of the twice-yearly injectable. At some 11 months since Gilead first launched the PrEP, it’s now time for many who have already received their first dose of Yeztugo to come in for their second yearly shot. So far, Gilead has reason to expect persistency levels for Yeztugo to “keep growing” over time and result in the highest in the overall HIV market, Mercier said. As it stands, the company is seeing “really good come-back” for the second dose within a certain time frame, which the company considers “really positive and encouraging.” “What we're seeing in early days is definitely much stronger than what the current competition is seeing in the marketplace,” Mercier said, referring to persistency levels. The “really strong” U.S. PrEP market growth of 14% is helping out Descovy as well, Mercier said. Gilead’s own U.S. PrEP business specifically climbed 87% from the same period last year, while Descovy enjoyed a 38% year-over-year sales climb to $807 million. With its PrEP and HIV treatment products combined, the company’s HIV portfolio collected a total of $5 billion over the first quarter, a 10% increase from 2025’s first quarter. Leading HIV treatment Biktarvy took home $3.4 billion in 7% growth of its own. Upcoming HIV treatment offeringsBiktarvy currently holds on to 52% of the U.S. HIV treatment market, but the first of many lenacapivir combinations Gilead hopes to soon commercialize is looking to corner a specific subset of the treatment market after its August FDA target decision date in people with virally suppressed HIV. The combo prospect is a single-tablet pairing of capsid inhibitor lenacapivir and bictegravir, one of the three ingredients in Biktarvy. With bic/len, the company looks to offer a simpler option for the 5% to 6% of people with HIV who take multiple pills a day with complex treatment regimens to manage the virus.Importantly, Gilead sees the bic/len combo as a way to get in on the treatment switch market, which is made up of 20% of people with HIV who switch treatments yearly. This switching pattern is based largely on the “innovative life cycle” of HIV treatments, Mercier explained. While the company expects Biktarvy to hold onto its standard-of-care status until its mid-2030’s patent cliff, bic/len marks a chance to “play in that switch market, which we haven’t had in the past,” as people with HIV could, in theory, switch from Biktarvy to the new combo “if they’re going to switch anyway,” the executive said.Gilead forecasts 8% growth in its HIV business during 2026, while its total product sales are expected to land between $30 billion and $30.4 billion. Over the first quarter, full revenues rose 4% to $7 billion compared to last year’s first quarter. Liver disease gains, cell therapy woes Aside from Yeztugo and its HIV gains, another growing highlight of Gilead’s product portfolio is primary biliary cholangitis (PBC) med Livdelzi. After launching in 2024, quarterly sales jumped 230% year-over-year to $133 million over 2026’s first quarter, with a sequential decline of 11% attributed to a “switch bolus” over the fourth quarter of 2025, when the drug’s once main rival in Intercept’s Ocaliva was pulled from the market.Meanwhile, a 12% year-over-year decline in Gilead’s cell therapy portfolio of Yescarta and Tecartus were again attributed to “continued competitive headwinds” across regions. Although breast cancer med Trodelvy and its $402 million quarterly haul has long shouldered the bulk of Gilead’s oncology-derived revenues, other potential oncology standouts are on the way. Outside of late-stage multiple myeloma CAR-T prospect anito-cel, which the company has full control of after buying out its partner Arcellx for $7.8 billion earlier this year, Gilead’s April acquisition of Germany-based Tubulis marked a $3.15 billion play for a promising antibody-drug conjugate (ADC) candidate in development for ovarian cancer and lung cancer. The ovarian cancer opportunity alone can justify the transaction price, Chief Financial Officer Andrew Dickinson commented.

Acquisition

11 Jan 2026

·www.drugs.com

Overcoming Obstacles to HIV Prevention

SUNDAY, Jan. 11, 2026 — Though an antiretroviral medication called PrEP provides near-perfect protection against HIV, patients must often surmount hurdles to obtain it. From medical stigma to insurance denials and doctors who are unfamiliar with the regimen, a new report finds that many LGBTQ+ people have had negative experiences trying to protect themselves from the virus that causes AIDS. Dr. Beth Oller, board member of GLMA, a nationwide organization of LGBTQ+ and allied health care professionals focused on health equity, has seen the fallout in her Kansas practice. “I have a lot of patients who had not done preventive care for years because of the medical stigma,” she told KFF Health News, a program of the nonprofit KFF. Taken as prescribed, PrEP — shorthand for preexposure prophylaxis — is 99% effective in protecting people against sexual transmission of the virus that causes AIDS. Matthew Hurley — who lives in the San Francisco Bay Area, which has one of the nation’s highest concentrations of LGBTQ+ people — shared his experience with KFF Health News . After having sex with someone who then tested positive for HIV, Hurley began taking PrEP. But when a change of insurance forced a change of doctors, he was surprised to discover that he knew more about the regimen than his new physician did. "When I brought up PrEP to him, he said, 'What’s that?' " Hurley told KFF . "And I was like, oh boy." He explained to his new doctor that he took a pill every day and had quarterly lab work to monitor for breakthrough infections or other health problems. After the physician did his own research, he agreed to prescribe PrEP. That was just the first in a series of hurdles Hurley had to surmount. While most private insurance plans and Medicaid expansion programs are required under the Affordable Care Act to cover PrEP and related services like lab tests with no cost sharing, Hurley spent months contesting charges and past-due notices. He finally found a provider that was better informed about PrEP — and hasn’t had an unexpected bill since. Still, he wishes he didn’t have to separate his sexual health care from his primary care. "I have multiple organizations that I have to deal with to get my holistic health dealt with," he said. To head off some of the problems Hurley encountered, KFF recommends: Find out if PrEP is right for you. Under guidelines from the U.S. Centers for Disease Control and Prevention (CDC), it can be prescribed to anyone who is sexually active. In particular, the CDC recommends it for people who don’t use condoms consistently, IV drug users who share needles, men who have sex with men and people whose partners are living with HIV or whose HIV status is unclear. Don’t assume your provider knows about PrEP. Check your state or local health department for a how-to guide you can share with your provider. The CDC also has PrEP guidelines, but some HIV/AIDS resources have been removed from federal websites. Go in-network for labs. To avoid a bill you shouldn’t have to pay, ask your doctor’s office to be careful about coding required lab work and to send you to a lab that is in-network. If the office makes mistakes, share the PrEP billing and coding guide from NASTAD, a non-profit association representing public health officials who oversee HIV and hepatitis programs. Seek savings. Truvada , the first approved PrEP drug, has several lower-cost, generic versions. Ask your doctor to prescribe meds your insurance will cover. Some drug makers have aid programs for qualifying patients. Consider telehealth and seek out affirming care: Roughly 20% of patients on PrEP used telemedicine in 2024. Online pharmacies like Mistr and Q Care Plus offer PrEP without an in-person appointment and lab work can be done at home. The LGBTQ+ Healthcare Directory is a searchable nationwide database of health care providers who identify as queer-friendly. Sources KFF Health News, Jan. 5, 2026

18 Oct 2025

·pharma.economictimes.indiatimes.com

UK's drug-cost watchdog recommends use of GSK unit's HIV prevention drug

Bengaluru: The UK's drugs cost-effectiveness watchdog has given a positive recommendation for ViiV Healthcare's HIV drug , enabling access to the preventive medicine via the state health system in England and Wales, the GSK unit said on Friday. The country's drug regulator had approved ViiV's injection, Apretude , last year for prevention of HIV-1 in adults and young people who weigh at least 35 kilograms and are at high risk of acquiring the infection. A positive recommendation from the National Institute for Health and Care Excellence, or NICE, solidifies the final guidance related to Apretude for National Health Service, ViiV said. It also allows the drug to be routinely funded and enables access through NHS. Pending any appeals, the drug will be available to eligible people in Wales within two months and in England within three months. Such preventative treatments, medically called pre-exposure prophylaxis or PrEP, are used to reduce the risk of acquiring HIV. Apretude provides an alternative for people who cannot, or prefer not to, take oral HIV-prevention medication. It won U.S. approval in late 2021 and in Europe in 2023, and generated 279 million pounds ($374.95 million) in global sales last year. The drug competes with U.S. drugmaker Gilead's oral daily pills Truvada and Descovy along with long-acting injectable drug Yeztugo. ViiV's drug can be given every two months, compared with Gilead's Yeztugo, which is given every six months. GSK is exploring a long acting version of Apretude that could potentially be dosed every four months or more. (Reporting by Christy Santhosh in Bengaluru; Editing by Leroy Leo)

Drug ApprovalClinical Study

100 Deals associated with Emtricitabine/Tenofovir Disoproxil Fumarate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Emtricitabine/Tenofovir Disoproxil Fumarate	J05AR03	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	United States	Gilead Sciences, Inc.	02 Aug 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Phase 3	France	Gilead Sciences, Inc.	01 Jan 2007
Hepatitis B, Chronic	Phase 3	United States	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Australia	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Bulgaria	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Canada	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Czechia	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	France	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Germany	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Greece	Gilead Sciences, Inc.	01 Feb 2005
Hepatitis B, Chronic	Phase 3	Italy	Gilead Sciences, Inc.	01 Feb 2005

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04760691 (CTgov)	Phase 1	HIV Infections	13	Truvada alone (Pre-Exposure Prophylaxis (PrEP) Only)	kclnweaada(pfiledwqxf) = hknndyjqtp ialfyzuryk (uzkwhqyhua, wvszlfzucl - vzrjxhgvbc) View more	-	03 Apr 2026
				Truvada+Leuprolide (PrEP Plus Gonadotropin Releasing Hormone (GnRH) Agonist)	kclnweaada(pfiledwqxf) = fgfhxuskfu ialfyzuryk (uzkwhqyhua, bojxvwskfa - lbwyuigixn) View more
NCT05072093 (Project PEACH, CTgov)	Phase 4	HIV Infections	240	PrEP discontinuation intervention+Injectable PrEP+Offering of STI PEP+Offering of on-demand oral PrEP	kmhmdnlwqb = stubnpltts akuxtgmxuv (tnkuddtbob, uswmsofsiq - fzidgazcue) View more	-	01 Apr 2026
NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	Phase 3	HIV Infections	251	Dapivirine vaginal ring	bwyiqujkmp(zorbmbrurj) = dkqgnbnkih tgyiqngcek (awvjklfibc ) View more	Positive	01 Mar 2026
NCT03512418 (PrEPSteps, CTgov)	Phase 3	HIV Infections	30	PrEPsteps+Truvada (PrEPsteps)	apzbqseimu = zgsplnwmgs znfmepcvpi (wkctilwmql, tuxrielnir - ymmcepdtmk) View more	-	17 Sep 2025
				Digital pill+Truvada (Control)	apzbqseimu = ejaewpwhhe znfmepcvpi (wkctilwmql, rcintxlhrn - iskpnvthle) View more
NCT01234116 (PEP, CTgov)	Phase 4	HIV Infections	16	emtricitabine/tenofovir disoproxil fumarate (Kaletra)	dinoqvxclr = anxfxhlaje gtarkftbfo (tqlbfkxxcg, odewrkjqvb - bhmvaiklct) View more	-	15 Aug 2025
				emtricitabine/tenofovir disoproxil fumarate (Raltegravir)	dinoqvxclr = xqzoblzwkb gtarkftbfo (tqlbfkxxcg, tppshyxolo - elpqppndqa) View more
NCT04636437 (CTgov)	Phase 4	HIV Infections \| Obesity	147	Doravirine 100 Mg+Integrase strand transfer inhibitors (DOR 100 mg + TAF/FTC)	cdjfgfqxkh(reenurbvdz) = abywodkllh pahkxkdmtq (ltpywlcavt, srufecxmlv - pbqowwtumd) View more	-	02 Jul 2025
				Doravirine 100 Mg+tenofovir disproxil fumarate/emtricitabine (DOR 100 mg + TDF/FTC)	cdjfgfqxkh(reenurbvdz) = wvlkphbadk pahkxkdmtq (ltpywlcavt, kwkkllznak - hzherqeion) View more
NCT02732730 (HPTN 082, CTgov)	Phase 4	HIV Infections	451	Drug level counseling at Weeks 8 and 13+Truvada (Enhanced Adherence Support)	noloyapuzy = lkvtuuzmqu pvsjxsnyvp (mndsqmgcur, bmcjbkpzrn - umxvxsgiga) View more	-	12 Jun 2025
				Truvada (Standard Adherence Support)	noloyapuzy = uizuwsivuk pvsjxsnyvp (mndsqmgcur, ojksbhwpbf - daemsfutzy) View more
NCT04692077 (CTgov)	Phase 2	HIV Infections	9	CAB LA+Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet	slvnhpkgbd(wihnhnaitb) = bsivmoxwbo hqlwrahdwo (eklliqlvwg, 1.3) View more	-	29 Jan 2025
NCT03048422 (IMPAACT 2010 (VESTED), Pubmed \| J Acquir Immune Defic Syndr)	Phase 3	bone mineral density \| creatinine clearance	-	Dolutegravir + emtricitabine/tenofovir alafenamide (DTG + FTC/TAF)	xxfjbtofxs(ngrtsoqnee) = etbxxwkooh oxymqjuzbo (ubooejhwke )	Positive	01 Oct 2024
				Dolutegravir + emtricitabine/tenofovir disoproxil fumarate (DTG + FTC/TDF)	xxfjbtofxs(ngrtsoqnee) = yasgcehorv oxymqjuzbo (ubooejhwke )
NCT04298697 (CTgov)	Phase 4	HIV Infections	43	Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (TDF/FTC for 1 Week)	evqndtjhml(mlhqtrtdqt) = uvrbhvbfgf ykejwnppho (mlddpnufeb, hnhchgamkw - qrkexkfwer) View more	-	19 Sep 2024
				Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (TDF/FTC for 13 Weeks)	evqndtjhml(mlhqtrtdqt) = ufgcjndphd ykejwnppho (mlddpnufeb, ndizktczna - yqtgcrvsiv) View more

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