This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.
A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

Start Date01 Mar 2025

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT05077215 / Not yet recruitingPhase 3

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).
Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:
Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
ECOG score at baseline (0 vs 1)
Geographic region (Asia vs ROW)

Start Date01 Dec 2024

Sponsor / Collaborator

Evergreen Therapeutics, Inc

NCT06333808 / RecruitingPhase 3

Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH).
The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.

Start Date25 Mar 2024

Sponsor / Collaborator

Gilead Sciences, Inc.

100 Clinical Results associated with Lenacapavir Sodium

100 Translational Medicine associated with Lenacapavir Sodium

100 Patents (Medical) associated with Lenacapavir Sodium

Literatures (Medical) associated with Lenacapavir Sodium

01 Feb 2024·The Annals of pharmacotherapy

Lenacapavir: A Novel Long-Acting Capsid Inhibitor for HIV

Review

Author: Sherman, Elizabeth M. ; Tailor, Marylee W. ; Chahine, Elias B. ; Koren, David

Objective::

To review the efficacy, safety, and role of lenacapavir (LEN) in the treatment of HIV-1 infection.

Data Sources::

A literature search was performed using PubMed and Google Scholar (through March 2023) with the search term LEN and GS-6207. Other resources included abstracts presented at recent conferences, the manufacturer’s Web site, and prescribing information.

Study Selection and Data Extraction::

All relevant articles, trial updates, and conference abstracts in the English language were included.

Data Synthesis::

Lenacapavir represents a new class of antiretrovirals (ARVs) with a novel mechanism of action as a capsid inhibitor and a unique twice-a-year subcutaneous administration schedule. Lenacapavir when combined with other ARVs has proven to benefit heavily treatment-experienced (HTE) patients with HIV-1 infection in achieving viral suppression and immune restoration.

Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs::

Lenacapavir is a new treatment option that patients who are HTE can consider adding as part of an ARV regimen.

Conclusions::

Lenacapavir is an effective and well-tolerated option for HTE patients which is a valuable addition to the arsenal of ARVs.

01 Jan 2024·Chemical & pharmaceutical bulletin

Development of Small-Molecule Anti-HIV-1 Agents Targeting HIV-1 Capsid Proteins

Article

Author: Sato, Hironori ; Kurakami, Masaki ; Kotani, Osamu ; Bolah, Peter ; Ishii, Takahiro ; Tamamura, Hirokazu ; Miura, Yutaro ; Yokoyama, Masaru ; Shinohara, Kouki ; Fujino, Masayuki ; Murakami, Tsutomu ; Kobayakawa, Takuya ; Yamamoto, Kenichi ; Tsuji, Kohei ; Boku, Sayaka ; Nishimura, Soshi

The capsid of human immunodeficiency virus type 1 (HIV-1) forms a conical structure by assembling oligomers of capsid (CA) proteins and is a virion shell that encapsulates viral RNA. The inhibition of the CA function could be an appropriate target for suppression of HIV-1 replication because the CA proteins are highly conserved among many strains of HIV-1, and the drug targeting CA, lenacapavir, has been clinically developed by Gilead Sciences, Inc. Interface hydrophobic interactions between two CA molecules via the Trp184 and Met185 residues in the CA sequence are indispensable for conformational stabilization of the CA multimer. Our continuous studies found two types of small molecules with different scaffolds, MKN-1 and MKN-3, designed by in silico screening as a dipeptide mimic of Trp184 and Met185 have significant anti-HIV-1 activity. In the present study, MKN-1 derivatives have been designed and synthesized. Their structure-activity relationship studies found some compounds having potent anti-HIV activity. The present results should be useful in the design of novel CA-targeting molecules with anti-HIV activity.

01 Mar 2024·The lancet. HIV

Lenacapavir plus two bNAbs: feasible, with some caveats

Article

Author: Martinez, Esteban

News (Medical) associated with Lenacapavir Sodium

20 Jun 2024

·www.biospace.com

Gilead’s Twice-Yearly Shot Shows 100% Efficacy in Phase III HIV Prevention Trial in Women

Pictured: Signage outside Gilead's headquarters in California/iStock, Sundry Photography Gilead Sciences’ antiviral demonstrated 100% efficacy for HIV prevention in cisgender women in Phase III trial results announced Thursday. The twice-yearly lenacapavir shot proved superior to Gilead’s already-approved oral medicines for HIV prevention, Truvada and Descovy. In the PURPOSE 1 trial, zero cases of HIV infection occurred among 2,134 women in the lenacapavir group, compared to 16 cases in the 1,068 women in the Truvada arm and 39 incidents among 2,136 women treated with Descovy. The long-acting shot was well-tolerated with no significant safety concerns, according to Gilead. “To have no infections in over 2,000 women... that’s a remarkable result,” Joe Eron, principal investigator at the HIV/AIDS Clinical Research Unit at University of North Carolina-Chapel Hill, told STAT News. While oral pre-exposure prophylaxis (PrEP) medications show high efficacy when taken daily, prior clinical trials for Descovy and Truvada found issues with patients adhering to the dosing. Superiority over Descovy was the primary endpoint of the PURPOSE 1 study, with proven efficacy over Truvada being the second endpoint. An independent data monitoring committee recommended Gilead unblind the trial and offer lenacapavir to all patients. “Twice-yearly lenacapavir for PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule,” Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, said in a statement. Lenacapavir is in development as a PrEP in patients at risk of HIV infection. Additional trials are assessing the biannual injections among a broader scope of patients including cisgender men, transgender men and women and non-binary individuals. Gilead will regulatory approval with results from both PURPOSE 1 and, if positive, PURPOSE 2 to gain approval for “communities most in need of additional HIV prevention options.” HIV products increased by 6% for the California-based pharma to $18.2 billion in revenue in 2023 compared to the prior year. Approved in 2019, Descovy sales make up about $2 billion of that number. There are over one million new HIV infections every year. The virus contributes to over 480,000 deaths worldwide annually. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

Phase 3Clinical ResultDrug Approval

30 May 2024

·www.pharmaceutical-technology.com

Gilead urged to improve access to HIV drug by public figures and celebrities

Gilead Sciences headquarters in Silicon Valley. Gilead’s HIV drug Sunlenca (lenacapavir) gained FDA approval in 2022. Credit: Sundry Photography via Shutterstock. Public figures, scientists, medical professionals, and celebrities have written an open letter to Gilead Sciences , urging them to provide fair access to “gamechanger” human immunodeficiency virus (HIV) drug Sunlenca (lenacapavir) in low- and middle-income countries (LMICs). Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - BRII-732 in Human Immunodeficiency Virus (HIV)... Reports Immuno-oncology (IO) - Thematic Intelligence Premium Insights The gold standard of business intelligence. Find out more Related Company Profiles Gilead Sciences Inc View all By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. In the open letter from the People’s Medicines Alliance, campaigners said the drug “could be a real gamechanger worldwide for the people most excluded from high-quality healthcare” and “help end AIDS as a public health threat by 2030 – but only if all who would benefit from it can access it”. The letter also suggested that the company licence the drug on the Medicines Patent Pool (MPP) – a Unitaid-backed international organisation – which would allow for cheaper generic versions to be manufactured. Currently, the company’s patent for Sunlenca will not run out until 2038. The drug, which is administered as two injections a year, has a list price of $42,250 in the US for the first year of treatment, and $39,000 for subsequent years. According to GlobalData’s Pharma Intelligence Center, Sunlenca is forecast to generate $3.1bn in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology. See Also: Compound medication pharmacies and companies Dupixent gets closer to EU approval as the FDA delays its decision on COPD The US Food and Drug Administration (FDA) approved Sunlenca plus other antiretrovirals to treat HIV-1 infections in 2022. This was following an approval from the European Commission earlier in the same year. Sunlenca isn’t the only HIV medication in Gilead’s portfolio, it also has fixed dose combination therapy, Biktarvy, an anti-retroviral therapy made up of the novel integrase inhibitor bictegravir, alongside Gilead’s already marketed combo therapy Descovy, which consists of emtricitabine and tenofovir alafenamide, among other drugs. In September 2017, Gilead signed a licensing agreement with the MPP for Biktarvy, benefiting at least 116 low-income countries. Gilead has faced extensive court battles over its tenofovir-based HIV drugs since 2001 when it launched tenofovir disoproxil fumarate (TDF). Although effective, TDF users risked skeletal and kidney damage. Around 24,000 TDF users have sued, arguing that Gilead delayed the development of tenofovir alafenamide fumarate (TAF), to maximise TDF profits despite early tests showing TAF had fewer risks. Gilead has defended itself, arguing that a plaintiff cannot seek compensation for harm caused by a product if that product is not proven defective. The US biopharma has also said that it had no duty to disclose facts relating to TAF when it had not yet been approved. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Thank you. You will receive an email shortly. Please check your inbox to download the Report. By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Tick here to opt out of curated industry news, reports, and event updates Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Drug ApprovalLicense out/inClinical Study

29 Apr 2024

·www.pharmaceutical-technology.com

Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

Gilead’s Biktarvy has previously been approved by the US FDA as HIV treatment in both adult and paediatric (weighing at least 14kg) populations. Image Credit: Michael Vi / Shutterstock. Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018. The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower plasma exposures observed during pregnancy compared to postpartum. All 29 newborn participants had negative or nondetectable HIV-1 polymerase chain reaction (PCR) results at birth and/or at four to eight weeks postbirth. In addition, the trial did not identify any new safety or tolerability concerns for people who use Biktarvy during pregnancy and postpartum. The overall incidence and types of adverse events observed were consistent with those expected for the population studied, as per Gilead. See Also: Accord BioPharma’s HERCESSI secures FDA approval Biktarvy is recommended as an alternative complete regimen for use in pregnancy and for people who are trying to conceive by the US Department of Health and Human Services (DHHS) perinatal guidelines. Biktarvy is a top revenue-generating therapy in Gilead’s portfolio and pulled in $2.9bn in sales in Q1 this year, as per the company’s financials. The sales for the therapy are expected to increase to $15.5bn in 2030, as per GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology . Another HIV therapy in Gilead’s portfolio is Sunlenca (lenacapavir), an FDA-approved multidrug-resistant HIV treatment . The company is evaluating Sunlenca in combination with Merck & Co’s islatravir as a long-acting HIV treatment for virologically suppressed people living with HIV.

Drug ApprovalPhase 1Clinical ResultPhase 2

100 Deals associated with Lenacapavir Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15673

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	EU	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022
HIV Infections	IS	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022
HIV Infections	LI	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022
HIV Infections	NO	Gilead Sciences Ireland Unlimited Co.	17 Aug 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05052996 (BusinessWire) Manual	Phase 2	HIV Infections	104	Islatravir+lenacapavir	mfhaoerocm(qyazvsqcon) = lqjbrippvx jcvqmexyqf (mdgtkhpnbs ) View more	Positive	06 Mar 2024
				Biktarvy	mtiymezzqj(btcrjgeruw) = dmdyjeggpx oogidktiys (jkbuoeyxcc )
NCT04143594 (CTgov)	Phase 2	HIV Infections	183	LEN 927+TAF+LEN (Group 1: LEN + F/TAF + TAF)	ibpuzruqef(uhhsimhlcg) = dbplrvkrud tpsycqctcu (xnqopaodsb, ymonnuqqfm - tvdrborfea) View more	-	19 Dec 2022
				TAF+LEN (Group 2: LEN + F/TAF + BIC)	ibpuzruqef(uhhsimhlcg) = twrjloyrkt tpsycqctcu (xnqopaodsb, qboyjnmdfg - ggsbxkzrct) View more
NCT04150068 (CAPELLA, Pubmed) Manual	Phase 3	HIV Infections Maintenance	72	lenacapavir (cohort 1)	lggiuxgyzr(floedpaljg) = No serious adverse events related to lenacapavir were identified qlsplrqqio (dpjfqakrjo ) View more	Positive	12 May 2022
				placebo (cohort 1)
NCT04143594 (CALIBRATE, Biospace) Manual	Phase 2	HIV Infections	182	Tenofovir Alafenamide Fumarate+lenacapavir	xjctentvej(dpgbaclqoi) = fuqxmhyibf conbrrphvc (zdbylfjrok )	Positive	16 Feb 2022
				Emtricitabine/Tenofovir Alafenamide Fumarate+lenacapavir	xjctentvej(dpgbaclqoi) = devonalfsl conbrrphvc (zdbylfjrok )
CALIBRATE (IAS2022)	Not Applicable	-	182	SC LEN + oral daily emtricitabine/tenofovir alafenamide (F/TAF)	tczfmbrgav(incnvyupdm) = yzdujowaqr jmqyojppft (pdtwtavgac )	-	01 Jan 2022
CAPELLA (IAS2022)	Not Applicable	HIV Infections	72	Lenacapavir	ltspusdhqu(reaogzasaz) = kphrvldzze nxwbqmokbx (mgmwrnjrzv )	-	01 Jan 2022
NCT04150068 (CTgov)	Phase 2/3	HIV Infections	72	Optimized Background Regimen (OBR)+Oral Lenacapavir (Cohort 1A: Lenacapavir)	dtpmgbdvvc(fknjavqbao) = crfdoefyut sdnmmgorhx (gdlmxdbhpr, rtiupdmuqg - btjegvwymd) View more	-	20 Oct 2021
				Optimized Background Regimen (OBR)+Oral Lenacapavir (Cohort 1B: Placebo to Lenacapavir)	dtpmgbdvvc(fknjavqbao) = gmhmypmmpy sdnmmgorhx (gdlmxdbhpr, sfvcqrpqko - fsjasupbjy) View more
NCT03739866 (CTgov)	Phase 1	HIV Infections	53	Lenacapavir+B/F/TAF (Part A: Lenacapavir 20 mg)	ufzlhdjyng(ncmijhigjh) = eyslksqovp izoxbmdfrj (bqruptuwkg, ctxhfhyuhw - acqrkhmyen) View more	-	09 Dec 2020
				Lenacapavir+B/F/TAF (Part A: Lenacapavir 50 mg)	ufzlhdjyng(ncmijhigjh) = ybpxwyvmof izoxbmdfrj (bqruptuwkg, lkhvpmwwqk - ceqcoafqik) View more
NCT04150068 (CAPELLA, Corporate Publications) Manual	Phase 2/3	HIV Infections	36	lenacapavir	jpldweufrh(aeajkicjpl) = invzcqvpbf jtgkiwcepa (wbmnzcebmy ) View more	Positive	18 Nov 2020
				Placebo	jpldweufrh(aeajkicjpl) = vfcvselyly jtgkiwcepa (wbmnzcebmy ) View more
ASCO2020	Not Applicable	Hepatocellular Carcinoma	26	LEN and anti-PD1 antibody combination therapy	eqwcyzxywh(dhhtqiczxm) = occurred in 6 (23.08%) patients oqjgjnkidg (evnqjailrb ) View more	Positive	25 May 2020

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis