An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1

The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.
The goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.
The goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.
The goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.
The primary objectives of this study are:
Phase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.
Phase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.

Start Date01 Jul 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

NCT07476339

/ RecruitingPhase 4IIT

A Multi-Center, Single-Arm, Open-Label, Prospective, Phase 4 Study to Investigate the Safety and Efficacy of Rapidly Restarting Oral Bictegravir, Emtricitabine, and Tenofovir Alafenamide (B/F/TAF) in Viremic and Virologically-Suppressed Male and Female HIV-Positive Patients Aged ≥18 Years Who Are Treatment-Experienced and Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks

Managing HIV well requires taking antiretroviral therapy (ART) every day, but many people living with HIV experience interruptions in their treatment. These pauses in medication can happen for many reasons, such as side effects, challenges with getting to the clinic, personal circumstances, stigma, or difficulties with everyday life. When HIV treatment is stopped, the viral load can increase, which may affect a person's health and make it easier for HIV to be passed on to others. Restarting treatment quickly after an interruption is important for both personal and public health. However, it can be difficult for people who miss doses to get back on treatment right away. There are often several steps and medical appointments required before restarting, such as waiting for lab results or reviewing medical history, which can cause further delays. These additional steps can make it even harder for people to re-engage and may discourage them from returning to care.
The REINITIATE study is designed for people living with HIV who have not taken any antiretroviral medications for at least the last 12 weeks. The study will offer participants a way to restart their HIV therapy quickly, by beginning treatment with B/F/TAF on the same day that they return to care. B/F/TAF is a widely used, once-daily HIV regimen, and is recommended in national treatment guidelines.
Researchers want to find out if this rapid restart approach is safe and effective, and whether it helps people regain control of HIV and remain in care. The study will also examine how many participants are able to keep the virus at a low level (viral suppression), stay engaged in their HIV care, and tolerate the medication after rapidly restarting treatment. In addition, the study will include interviews with some participants, to gain a better understanding of why they stopped taking their medications and what supported their return to treatment. These insights could help healthcare teams develop better ways to support people living with HIV in the future.

Start Date17 Jun 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

[+1]

NCT07645287

/ RecruitingPhase 2

A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.
The primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.

Start Date15 Jun 2026

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

100 Translational Medicine associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

100 Patents (Medical) associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

166

Literatures (Medical) associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

01 Jun 2026·HIV MEDICINE

Real‐world use of second‐generation integrase strand transfer inhibitors ( INSTI ) as switch therapy in the prospective ANRS ‐ CO3 ‐ AquiVIH ‐ NA cohort

Article

Author: Neau, D. ; Leleux, O. ; Le Moal, G. ; Gérard, Y. ; Cazanave, C. ; Lazaro, E. ; Reigadas, S. ; Peyrouny‐Mazeau, A. ; Perrier, A. ; Barrière, G. ; Bonnet, F. ; Duffau, P. ; Alleman, L. ; Vandenhende, M.‐A. ; Riché, A. ; Hessamfar, M.

Abstract:

Objectives:

To characterize real‐world treatment switching in France to bictegravir (BIC or B) or dolutegravir (DTG)‐based regimens with a focus on treatment persistence, effectiveness (HIV‐1 RNA ≤50 copies/ml) and particular attention to the prevalence and incidence of comorbidities.

Methods:

People living with HIV from the prospective ANRS‐CO3‐AquiVIH‐NA cohort, who switched from effective antiretroviral treatment (ART) to a BIC‐ or DTG‐based regimen between 2018 and 2021, were eligible for analysis.

Results:

A total of 2275 people living with HIV were included (52% receiving B/F/TAF, 8% DTG/3TC/ABC, 18% DTG/RPV, 22% DTG/3TC) with a median age of 53–56 years and a comorbidity prevalence of 71%–75% across treatment groups (chronic kidney disease (CKD) 15%–25%, diabetes mellitus 15%–19%, hypertension 57%–64%).Viral suppression rates at month 18 (LOCF, last observation carried forward) using a missing‐equals‐excluded (M = E) approach were 97% on B/F/TAF, 95% on DTG/3TC/ABC, 97% on DTG/RPV and 96% on DTG/3TC. Discontinuation rates were 16.5% for B/F/TAF, 37.5% for DTG/3TC/ABC, 16.7% for DTG/RPV and 17.3% for DTG/3TC, driven by adverse events in 5.6%, 12.5%, 5.6% and 6.1%, respectively.Comorbidity incidence rates/1000 person years in those free of the respective disease were 39 for hypertension, 22 for diabetes mellitus, 13 for cardiovascular events and 5 for CKD.

Conclusions:

In this real‐world cohort, treatment persistence 18 months after therapy switch was similar for B/F/TAF, DTG/RPV and DTG/3TC, but significantly lower for DTG/3TC/ABC. All regimens maintained high levels of viral suppression. Furthermore, the cohort illustrates the disease burden experienced by middle‐aged and elderly people living with HIV and highlights the importance of adapting ART to the specific needs of this population.

01 Jun 2026·AIDS

Antiretroviral resistance in at least second-line HIV-1 treatment virologic failure with common InSTI-based regimens

Article

Author: Marcelin, Anne-Geneviève ; Gruber, Joshua ; Charpentier, Charlotte ; Prata Menezes, Neia ; Barriere, Guillaume ; Calvez, Vincent ; Wirden, Marc ; Soulie, Cathia ; Descamps, Diane ; Lim, Travis

Objective::

To assess the prevalence and patterns of treatment-emergent resistance-associated mutations (RAMs) in people with HIV (PWH) with ≥1 prior regimen experiencing virologic failure (VF) with bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF), dolutegravir/lamivudine (DTG/3TC), or cabotegravir/rilpivirine (CAB + RPV) in an observational setting.

Design::

A noninterventional, multicenter, retrospective, observational study was conducted between January 1, 2022 and December 31, 2024 using a national French multicenter database of genotypic resistance assays performed at confirmed VF.

Methods::

VF was defined as 2 consecutive HIV-1 plasma viral loads of >50 copies/mL. Genotypic resistance assays were performed using Sanger sequencing. Treatment-emergent RAMs were characterized using the 2024 ANRS algorithm. Clinical history, virologic history, and demographic data were collected from medical records during standard clinical follow-up.

Results::

A total of 6523 PWH were followed over 3 years. The prevalence of VF during follow-up was 6% with B/F/TAF, 5% with DTG/3TC, and 5% with CAB + RPV. The prevalence of treatment-emergent RAMs at VF were 3% with B/F/TAF, 15% with DTG/3TC, and 32% with CAB + RPV. Dual treatment-emergent integrase strand transfer inhibitor (InSTI) and nucleoside reverse transcriptase inhibitor (NRTI) RAMs were observed with B/F/TAF and DTG/3TC, while dual treatment-emergent nonnucleoside reverse transcriptase inhibitor (NNRTI) and InSTI RAMs were observed with CAB + RPV.

Conclusions::

The overall prevalence of VF was low for all regimens. B/F/TAF was associated with a numerically lower prevalence of RAMs at VF compared with DTG/3TC and CAB + RPV. These observational findings highlight the importance of monitoring resistance patterns to optimize HIV treatment outcomes.

01 Jun 2026·THERAPEUTIC DRUG MONITORING

Simultaneous Quantification of Bictegravir and Emtricitabine Using a Simple and Economical Liquid Chromatography–Ultraviolet Method for Therapeutic Drug Monitoring in Patients With Human Immunodeficiency Virus

Article

Author: Wang, Zihe ; Zhang, Yang ; Liu, Wei ; Bai, Haihong ; Zhang, Tong ; Fang, Yuan

Background::

Biktarvy is an effective antiviral drug for patients with HIV. However, owing to its long-term use and poor patient adherence, sustained and effective Biktarvy treatment is consistently limited by insufficient in vivo drug concentrations. Liquid chromatography (LC)–tandem mass spectrometry–based therapeutic drug monitoring is a common tool for identifying inadequate dosages and preventing antiviral failure. However, this tool requires expensive instruments and reagents, which is a major limitation in resource-limited regions.

Methods::

A simple and economical liquid chromatography–ultraviolet method was established and validated for simultaneous quantification of Biktarvy-derived bictegravir (BIC) and emtricitabine (FTC) in human plasma. The samples were pretreated through protein precipitation with acetonitrile, and chromatographic separation was performed on a C18 analytical column with gradient elution at a flow rate of 1.0 mL/min. The total runtime for each sample was 15.0 minutes.

Results::

The method exhibited good linearity within the range of 0.5–20.0 mcg/mL for both BIC and FTC. The selectivity, lower limit of quantification, specificity, precision, accuracy, recovery, stability, and dilution integrity were validated, and all satisfied the requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: Bioanalytical method validation and study sample analysis (2022 edition) and the Chinese Pharmacopoeia for bioanalytical method validation (2015 edition). Furthermore, the method exhibited satisfactory performance, with BIC and FTC concentrations ranging between 0.80 and 6.99 mcg/mL and 0.53–4.57 mcg/mL, respectively.

Conclusions::

A simple and economical liquid chromatography–ultraviolet method was successfully developed for simultaneous quantification of BIC and FTC in human plasma. This method can be extensively used in therapeutic drug monitoring, as in the case of MS-based instrumental deficiency or damage, and in pharmacokinetic studies.

234

News (Medical) associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

09 Jun 2026

·www.fiercepharma.com

Merck, Gilead score in effort to develop the first weekly HIV pill

Merck and Gilead have combined their drugs islatravir and lenacapavir to develop what could soon become the first long-acting oral HIV treatment that can be taken weekly. A combination of Merck’s islatravir and Gilead’s lenacapavir has succeeded in two phase 3 trials and is in line to become the first long-acting oral HIV treatment that can be taken weekly.Both trials of the combination regimen—which includes a 2 mg dose of islatravir and a 300 mg dose of lenacapavir—included people with HIV who are virologically suppressed and both achieved their primary efficacy endpoint. In the Islend-1 study, the combo showed its non-inferiority in those who had switched off Gilead’s once-daily pill Biktarvy. In Islend-2, the combo measured up in those who had switched off standard-of-care antiretroviral regimens. No new safety concerns were identified in either study.Gilead and Merck said they plan to submit the data to regulatory authorities around the world and present the findings at a future scientific congress.“Long-acting oral therapies represent a new wave of transformational innovation in HIV drug development, with the potential to reshape the landscape of care,” said Jared Baeten, M.D, Ph.D, Gilead’s SVP, Clinical Development, Virology Therapeutic Area Head, said in a release. “Innovative oral HIV treatment options that allow for less frequent dosing may make a meaningful difference in the lives of people living with the virus, potentially offering more flexibility and discretion.”In a note to clients, analysts from Jefferies said that they viewed the data as a “plus,” but that they expect Biktarvy to remain the standard of care because of its well-established efficacy. While five-year data on Biktarvy has shown that 97% of patients remain suppressed, questions remain about the long-term safety and resistance of ISL/LEN.Gilead’s lenacapavir has been on the market since 2022, when it was approved in the U.S. as Sunlenca for twice-yearly administration for those with drug-resistant HIV. Twelve months ago, the FDA signed off on lenacapavir for pre-exposure prophylaxis (PrEP). It is known commercially in that indication as Yeztugo.Less than two months ago, islatravir was approved for the first time by the FDA in combination with the company’s doravirine. The regimen, known commercially as Idvynso, was endorsed to replace current antiretroviral regimens among adults with HIV who are virologically suppressed and who have no history of virologic treatment failure or treatment substitutions due to doravirine resistance. While islatravir is a newer nucleoside reverse transcriptase translocation inhibitor (NRTTI), doravirine is an older non-nucleoside reverse transcriptase inhibitor (NNRTI). Doravirine has been commercialized since 2018 as part of Merck’s HIV meds Pifeltro and Delstrigo.Gilead dominates the HIV market, recording sales of $14.3 billion last year for Biktarvy. HIV is part of Merck's infectious disease portfolio, which the company projects can generate $15 billion in annual sales by the middle of the next decade, according to a recent presentation.

Phase 3Drug ApprovalClinical ResultClinical Study

09 Jun 2026

·www.biospace.com

Merck, Gilead serve ‘sweet and sour’ spread after HIV win, cancer stumble

iStock, Diana Danchenko While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data. Monday was a mixed bag for Merck and Gilead Sciences, which notched key Phase 3 victories for their weekly HIV pill but reported disappointing late-stage data for their lung cancer combo. “Sweet and sour,” BMO Capital Markets quipped in a Monday evening note. On the sweet side, the latest readout could establish the investigational drug—a single-tablet combo of islatravir and lenacapavir (IS/LEN)—as “the first long-acting oral HIV treatment, strengthening Gilead/Merck’s positioning in the market.” This win, however, may be “muted” by the failure of the investigational regimen comprising Gilead’s antibody-drug conjugate Trodelvy with Merck’s PD-1 blockbuster Keytruda to significantly improve survival in patients with metastatic non-small cell lung cancer (NSCLC). On the HIV front, the pharma partners tested their single-pill drug combo in the Phase 3 ISLEND-1 and ISLEND-2 studies in patients with HIV who have been virologically suppressed either through Gilead’s Biktarvy or other standard-of-care antiretroviral therapies. At 48 weeks, the IS/LEN pill was non-inferior to Biktarvy or other standard regimens at maintaining virological suppression, according to a news release on Monday . BMO called this outcome “incrementally positive,” but said that IS/LEN could help the companies—Gilead in particular—access the “subset of virally suppressed patients who would prefer less frequent oral options.” With these findings, the analysts added, “Gilead continues to stay ahead of the HIV treatment curve.” For Merck, meanwhile, the ISLEND data could help the pharma establish itself “as a more meaningful competitor in HIV as the company aims to strengthen its presence in the indication,” BMO said. The companies did not provide specific data in their press announcement but promised to do so at a future medical congress. Merck and Gilead will also ISLEND data to regulatory authorities globally. The positive data in HIV could also help offset Gilead’s latest cancer blow. HIV Gilead, Merck Clear Path to Market for Daily HIV Pills With New Late-Stage Data At the 2026 Conference on Retroviruses and Opportunistic Infections, Gilead and Merck demonstrated that their respective daily oral HIV drugs can match current therapies in keeping the virus at bay. February 26, 2026 · 2 min read · Tristan Manalac Read more Also on Monday, Merck and Gilead announced that they would be discontinuing the Phase 3 KEYNOTE-D46 trial (also known as EVOKE-03), studying a combo regimen of Trodelvy and Keytruda in NSCLC patients with PD-L1-positive tumors. An independent data board found a “numerical improvement” in progression-free survival, but compared with Keytruda monotherapy, this effect fell short of statistical significance. The data committee also noted that it would be “unlikely” for the drug doublet to elicit significant overall survival improvements at the final analysis, prompting the companies to pull the plug on the program. For Gilead, this outcome “adds to challenging misses for Trodelvy,” BMO said, especially in NSCLC, where a first-line approval “would have supported accelerated revenue growth for the product.” Trodely previously failed a Phase 3 study in this indication, unable to significantly boost overall survival versus docetaxel, according to a January 2024 readout. Trodelvy grew 6% in 2025 to bring in $1.4 billion.

Phase 3Clinical Result

08 Jun 2026

·firstwordpharma.com

Gilead's lung cancer bid for Trodelvy hits wall, but HIV studies deliver better news

Gilead Sciences and Merck & Co. began the week with a mixed clinical scorecard.In back-to-back announcements Monday, the partners revealed they are discontinuing a Phase III study testing Gilead's TROP2-directed antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in combination with Merck's Keytruda (pembrolizumab) in lung cancer, while at the same time touting the success of their experimental once-weekly HIV pill in two other late-stage trials.The oncology setback throws a wrench into Gilead's expansion plans for Trodelvy, which is currently approved for two forms of breast cancer and for urothelial cancer. Lung cancer is a key target, but success so far has been uneven; the Phase III EVOKE-01 trial testing the TROP2 ADC as monotherapy against docetaxel in second-line non–small-cell lung cancer (NSCLC) failed in 2024.'Numerical improvement'Meanwhile, the earlier mid-stage EVOKE-02 trial suggested that combining the drug with Keytruda could be promising in newly diagnosed patients, but that momentum doesn't appear to have carried into Phase III. As a result, the companies have decided to halt the EVOKE-03 trial (also known as KEYNOTE-D46).The study, which was testing the combo against Keytruda monotherapy, enrolled previously untreated metastatic NSCLC patients whose tumours expressed high levels of PD-L1. The decision followed a review by an external data monitoring committee, which found that although the Trodelvy-Keytruda combination produced a "numerical improvement" in progression-free survival, it failed to achieve statistical significance. The committee also concluded that the probability of achieving a significant overall survival benefit at the final analysis was "unlikely." No new safety signals were identified.The companies said there are no changes to other ongoing Trodelvy or Merck studies. The Trodelvy-Keytruda pairing was tested in the triple-negative breast cancer ASCENT-04 and ASCENT-05 studies in the first-line metastatic and high-risk adjuvant settings, respectively.Non-inferiority to Biktarvy, ARTWhile the oncology programme stumbled, Gilead and Merck delivered more encouraging news involving their ongoing HIV partnership.The investigational once-weekly single-tablet regimen combining Gilead's capsid inhibitor lenacapavir with Merck's islatravir, a nucleoside reverse transcriptase translocation inhibitor, met the primary endpoint in both Phase III ISLEND-1 and ISLEND-2 studies of virologically suppressed patients at week 48.In ISLEND-1, the regimen was found to be statistically non-inferior to Gilead's Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), while ISLEND-2 showed non-inferiority against a range of standard-of-care daily oral antiretroviral therapy (ART) regimens. Safety findings were generally similar to the comparator treatments.The companies said they intend to file the data with regulators around the world for what could become the first once-weekly oral treatment option for people with HIV.Lenacapavir is already on the market as Sunlenca for multi-drug-resistant HIV and Yeztugo as a twice-yearly preventive shot. In April, the FDA approved a once-daily single-tablet regimen combining islatravir with doravirine under the name Idvynso for adults with virologically suppressed HIV-1.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Bictegravir/Emtricitabine/Tenofovir Alafenamide Fumarate

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Gilead Sciences, Inc.	07 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fasting	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Aug 2022
Metabolic Syndrome	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Aug 2022
Obesity	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Aug 2022
Hepatitis B	Phase 3	United States	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	China	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Japan	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Dominican Republic	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	France	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Greece	Gilead Sciences, Inc.	30 May 2018
Hepatitis B	Phase 3	Hong Kong	Gilead Sciences, Inc.	30 May 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05405751 (SIMPLIFIED, CTgov)	Phase 4	HIV Infections	101	Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]	fegidhidqg = vxaawgmexg ekbfygdmcx (wwqasetump, bptpwbxbyl - idilhlxwcz) View more	-	30 Jun 2026
NCT05648201 (PANNA-B PK, CTgov)	Phase 4	HIV Infections	20	Doravirine 100Mg Tab (Doravirine)	chvabeawvn(kmdnkoqotz) = xdcmqztbep jdiurixead (evlavjzmsm, 21) View more	-	16 Apr 2026
				Biktarvy 50/200/25 Tab (Biktarvy)	chvabeawvn(kmdnkoqotz) = elhvwuckne jdiurixead (evlavjzmsm, 19.4) View more
NCT06104306 (CTgov)	Phase 4	HIV Infections	33	B/F/TAF	tzxyrpqgmm = hbnxdtohfd yspfopghvk (nvzukoqkqz, ekzyixeekw - gzcdhoahag) View more	-	11 Feb 2026
NCT04712058 (Pubmed \| Int J Infect Dis)	Phase 3	HIV Infections	225	Bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF)	mlulvteqsc(pxkmnauolr) = bytrrbisnn wrsqizslwj (uaijhurbbr ) View more	Positive	01 Dec 2025
NCT04734652 (INSIGHT, Pubmed \| Lancet HIV)	Phase 2	HIV Infections	122	Bictegravir-emtricitabine-tenofovir alafenamide	aodrmrywez(gkldyslmkd) = ytxirbothv frhlyppejk (jpmslddnvc, 86 - 98) View more	Positive	01 Dec 2025
				Dolutegravir + tenofovir + lamivudine	aodrmrywez(gkldyslmkd) = hgettrorcv frhlyppejk (jpmslddnvc, 84 - 99) View more
NCT05122754 (Pubmed \| Infect Dis Ther)	Phase 3	HIV Infections	150	Bictegravir/Emtricitabine/Tenofovir Alafenamide	votwobgtoz(kbkwddpoqk) = ciwhlcamdc vimsgobrwf (fcahpnsrda, 0.20 - 4.12) View more	Positive	21 Nov 2025
				Tenofovir Disoproxil Fumarate-Based Regimens	votwobgtoz(kbkwddpoqk) = xxckhmwjoy vimsgobrwf (fcahpnsrda, −0.52 - 3.15) View more
NCT04734652 (INSIGHT study \| INSIGHT, CTgov)	Phase 2	Acquired Immunodeficiency Syndrome \| Pulmonary Tuberculosis	122	Biktarvy® (BIC Arm)	ocgfrbemsd = tefcbmpnxm tjpgasvucr (abzziyntas, vtpmlmqcov - skyflflyla) View more	-	15 Aug 2025
				Tenofovir+Dolutegravir+Lamivudine (DTG Arm)	ocgfrbemsd = dpjketrchb tjpgasvucr (abzziyntas, bxotgfcgqg - vtoofxepzs) View more
NCT02607956 \| NCT02607930 (Pubmed \| AIDS Res Ther)	Phase 3	HIV Infections First line	1,268	Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)	vywxinkxmr(fjugpqrhmr) = foqzkbecgk ifffeobbat (zpihrwqhsg ) View more	Positive	07 Apr 2025
				dolutegravir + emtricitabine/tenofovir alafenamide	vywxinkxmr(fjugpqrhmr) = wnraurqdoj ifffeobbat (zpihrwqhsg ) View more
NCT03580668 (BICSTaR, BusinessWire) Manual	Not Applicable	HIV Infections	-	Biktarvy (treatment‐naïve)	fzwbfdrrsw(irkjyrjntp) = nuazpiqhko ohfpepscdk (egaxhsvmrn ) View more	Positive	12 Nov 2024
				Biktarvy (treatment‐experienced)	fzwbfdrrsw(irkjyrjntp) = ysmkthetup ohfpepscdk (egaxhsvmrn ) View more
NCT03547908 (ALLIANCE, BusinessWire) Manual	Phase 3	Hepatitis B \| HIV Infections	-	Biktarvy	vpublworkj(octhqjpijz) = gfstabanmu qijrlpdnsp (aoazujrits ) View more	Positive	12 Nov 2024

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