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- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, doravirine/islatravir (MK-8591A) / Merck (MSD)
Renal safety parameters of doravirine/islatravir (100/0.75 mg) vs bictegravir/emtricitabine/tenofovir alafenamide once-daily as initial HIV-1 treatment: week 48 results from a randomized, double-blind phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_618;
P3
One participant in the B/F/TAF group experienced serious acute kidney injury and discontinued treatment. Conclusions :
- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, doravirine/islatravir (MK-8591A) / Merck (MSD)
Renal safety parameters of doravirine/islatravir (100/0.75 mg) vs bictegravir/emtricitabine/tenofovir alafenamide once-daily as initial HIV-1 treatment: week 48 results from a randomized, double-blind phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_617;
P3
One participant in the B/F/TAF group experienced serious acute kidney injury and discontinued treatment. Conclusions :
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Subgroup analysis of week 48 efficacy and safety of doravirine/islatravir (100 mg/0.75 mg) once daily as initial HIV-1 treatment in a double-blind phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_608;
P3
Conclusions : Purpose :
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Subgroup analysis of week 48 efficacy and safety of doravirine/islatravir (100 mg/0.75 mg) once daily as initial HIV-1 treatment in a double-blind phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_607;
P3
Purpose : Purpose :
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and safety of doravirine/islatravir (100 mg/0.75 mg) once daily in heavily treatment-experienced persons with HIV-1: week 49 results from a phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_606;
P3
Purpose : Conclusions :
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and safety of doravirine/islatravir (100 mg/0.75 mg) once daily in heavily treatment-experienced persons with HIV-1: week 49 results from a phase 3 trial (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_605;
P3
Conclusions : Conclusions :
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) (clinicaltrials.gov) - Sep 25, 2023
P3, N=501, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Conclusions : Recruiting --> Active, not recruiting
- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, doravirine/islatravir (MK-8591A) / Merck (MSD)
Switch to fixed-dose doravirine/islatravir (100/0.75 mg) once daily in adults with HIV-1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide: week 96 results of a phase 3, randomized, double-blind, non-inferiority trial (POLONEZ) - Sep 10, 2023 - Abstract #EACS2023EACS_223;
P3
Protocol-specified discontinuation criteria for CD4+ T-cell and/or TL count declines contributed to the efficacy difference between groups in the FAS. Decreases in cell counts accounted for many treatment-related AEs and discontinuations due to AEs with DOR/ISL.
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) - Aug 18, 2023
P3, N=500, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Decreases in cell counts accounted for many treatment-related AEs and discontinuations due to AEs with DOR/ISL. Trial completion date: Jul 2026 --> Nov 2026 | Trial primary completion date: Mar 2025 --> Oct 2025
- | Pifeltro (doravirine) / Merck (MSD)
Preclinical, Journal: Doravirine responses to HIV-1 viruses bearing mutations to NRTIs and NNRTIs under in vitro selective drug pressure. (Pubmed Central) - Jun 12, 2023
Doravirine showed favourable resistance profiles against viruses harbouring NRTI and NNRTI RAMs. The high barrier to resistance to doravirine coupled with the long intracellular half-life of islatravir may provide the opportunity for long-acting treatment options.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Weight and body composition after switch to doravirine/islatravir (DOR/ISL) 100/0.75mg once daily: week 48 results from 2 randomized active-controlled phase 3 trials, MK8591A-017 (P017) and MK8591A-018 (P018) (Plaza Ballroom/Channel 3) - May 5, 2023 - Abstract #IASHIV2023IAS_HIV_336;
The high barrier to resistance to doravirine coupled with the long intracellular half-life of islatravir may provide the opportunity for long-acting treatment options. Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST).
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Renal safety parameters after switch to doravirine/islatravir (DOR/ISL 100/0.75mg) once-daily: week 48 results from 2 randomized, active-controlled phase 3 trials, MK8591A-017 (P017) and MK8591A-018 (P018) (Poster Exhibition area) - May 5, 2023 - Abstract #IASHIV2023IAS_HIV_198;
Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST).
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - May 3, 2023
P3, N=643, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Embargoes on oral abstracts and posters lift on Monday, 24 July 2023, at 09:00 Australian Eastern Standard Time (AEST). Trial completion date: Jan 2024 --> May 2024
- |||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) (clinicaltrials.gov) - Mar 23, 2023
P3, N=1300, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jan 2024 --> May 2024 Not yet recruiting --> Recruiting
- |||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) - Mar 16, 2023
P3, N=500, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054) (clinicaltrials.gov) - Mar 13, 2023
P3, N=1300, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) (clinicaltrials.gov) - Mar 6, 2023
P3, N=501, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) (clinicaltrials.gov) - Mar 2, 2023
P3, N=501, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion, Trial completion date: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Feb 24, 2023
P2, N=42, Completed, Sponsor: Merck Sharp & Dohme LLC
Not yet recruiting --> Recruiting Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jan 2023
- |||||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) - Jan 30, 2023
P3, N=500, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment change, Trial completion date, Trial primary completion date: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (clinicaltrials.gov) - Jan 6, 2023
P3, N=35, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jan 2023 N=100 --> 35 | Trial completion date: Aug 2025 --> Oct 2023 | Trial primary completion date: Jul 2024 --> Nov 2022
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) (clinicaltrials.gov) - Dec 23, 2022
P3, N=2000, Recruiting, Sponsor: Merck Sharp & Dohme LLC
N=100 --> 35 | Trial completion date: Aug 2025 --> Oct 2023 | Trial primary completion date: Jul 2024 --> Nov 2022 Trial completion date: Jun 2027 --> Oct 2025
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial primary completion date: Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) (clinicaltrials.gov) - Dec 15, 2022
P3, N=2000, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jun 2027 --> Oct 2025 Trial primary completion date: Sep 2024 --> Oct 2025
- |||||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) (clinicaltrials.gov) - Nov 30, 2022
P3, N=501, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- |||||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
New P3 trial: A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051) (clinicaltrials.gov) - Nov 30, 2022
P3, N=501, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (clinicaltrials.gov) - Nov 29, 2022
P3, N=672, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial primary completion date: Sep 2024 --> Oct 2025 Trial completion date: Sep 2022 --> Mar 2024
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - Nov 4, 2022
P3, N=643, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Sep 2022 --> Mar 2024 Trial completion date: Aug 2023 --> Jan 2024
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) (clinicaltrials.gov) - Oct 14, 2022
P3, N=2000, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Aug 2023 --> Jan 2024 Trial completion date: Aug 2028 --> Jun 2027 | Trial primary completion date: Nov 2025 --> Sep 2024
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Oct 14, 2022
P2, N=42, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Aug 2028 --> Jun 2027 | Trial primary completion date: Nov 2025 --> Sep 2024 Trial completion date: Sep 2022 --> Sep 2023
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Oct 10, 2022
P3, N=680, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Sep 2022 --> Sep 2023 Trial completion date: Sep 2025 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Nov 2022
- || doravirine/islatravir (MK-8591A) / Merck (MSD)
Clinical, Journal, Combination therapy: Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine. (Pubmed Central) - Aug 24, 2022
P2b
Trial completion date: Sep 2025 --> Dec 2024 | Trial primary completion date: Aug 2023 --> Nov 2022 Treatment regimens containing islatravir and doravirine maintained viral suppression through week 96 and were well tolerated regardless of dose.
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Aug 22, 2022
P3, N=680, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Treatment regimens containing islatravir and doravirine maintained viral suppression through week 96 and were well tolerated regardless of dose. Trial completion date: Feb 2025 --> Sep 2025 | Trial primary completion date: Jan 2023 --> Aug 2023
- | Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Journal: Doravirine and Islatravir Have Complementary Resistance Profiles and Create a Combination with a High Barrier to Resistance. (Pubmed Central) - May 20, 2022
Resistance analysis showed no emergence of substitutions at F227, an observation consistent with its ability to confer hypersusceptibility to ISL. Overall, the data demonstrate that DOR/ISL creates a 2-drug combination with a higher barrier to resistance, consistent with the reported clinical activity.
- ||| islatravir (MK-8591) / Merck (MSD)
Trial completion: DRIVE2Simplify: Islatravir (MK-8591) With Doravirine and Lamivudine in Participants Infected With Human Immunodeficiency Virus Type 1 (MK-8591-011) (clinicaltrials.gov) - Apr 27, 2022
P2b, N=123, Completed, Sponsor: Merck Sharp & Dohme Corp.
Overall, the data demonstrate that DOR/ISL creates a 2-drug combination with a higher barrier to resistance, consistent with the reported clinical activity. Active, not recruiting --> Completed
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Mar 23, 2022
P2, N=42, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Trial completion date: Jan 2024 --> Sep 2022
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) (clinicaltrials.gov) - Mar 14, 2022
P3, N=2000, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Jan 2024 --> Sep 2022 Trial completion date: Feb 2029 --> Aug 2028 | Trial primary completion date: May 2026 --> Nov 2025
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Trial primary completion date: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Feb 7, 2022
P2, N=42, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial completion date: Feb 2029 --> Aug 2028 | Trial primary completion date: May 2026 --> Nov 2025 Trial primary completion date: Jul 2022 --> Dec 2021
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Jan 18, 2022
P3, N=680, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Jul 2022 --> Dec 2021 Recruiting --> Active, not recruiting
- | Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ?35 kg (MK-8591A-028) (clinicaltrials.gov) - Dec 22, 2021
P2, N=45, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (clinicaltrials.gov) - Dec 22, 2021
P3, N=100, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || doravirine/islatravir (MK-8591A) / Merck (MSD)
This issue not reported in press release of Phase 3 islatravir/doravirine studies in October. https://t.co/NDMjT8HoYy (Twitter) - Nov 19, 2021
- |||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033) (clinicaltrials.gov) - Sep 20, 2021
P3, N=2000, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Preclinical, Journal: Cell culture selections reveal favourable drug resistance profiles for doravirine and islatravir. (Pubmed Central) - Aug 12, 2021
Doravirine showed a more robust resistance profile compared with other NNRTIs. The long intracellular half-life of islatravir and delayed acquisition of resistance in dual selections provide an opportunity for long-acting treatment options.
- || Pifeltro (doravirine) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Clinical, P1 data, Journal: A Phase 1 Study to Evaluate the Drug Interaction Between Islatravir (MK-8591) and Doravirine in Adults Without HIV. (Pubmed Central) - Aug 12, 2021
The long intracellular half-life of islatravir and delayed acquisition of resistance in dual selections provide an opportunity for long-acting treatment options. These results indicate that coadministration of islatravir and doravirine had no clinically meaningful effect on the pharmacokinetics of either drug, and support further clinical investigation of islatravir in combination with doravirine for the treatment of HIV-1 infection.
- || doravirine/islatravir (MK-8591A) / Merck (MSD)
Clinical, P2b data, Journal, Combination therapy: Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial. (Pubmed Central) - Jul 23, 2021
P2b
Treatment regimens containing islatravir and doravirine showed antiviral efficacy and were well tolerated regardless of dose. Doravirine in combination with islatravir has the potential to be a potent two-drug regimen that warrants further clinical development.
- |||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date, Trial primary completion date: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Jul 7, 2021
P3, N=680, Recruiting, Sponsor: Merck Sharp & Dohme Corp.
Doravirine in combination with islatravir has the potential to be a potent two-drug regimen that warrants further clinical development. Trial completion date: Nov 2023 --> Jan 2025 | Trial primary completion date: Nov 2023 --> Dec 2022
- doravirine/islatravir (MK-8591A) / Merck (MSD)
[VIRTUAL] Week 96 metabolic and bone outcomes of a Phase 2b trial of islatravir and doravirine () - May 27, 2021 - Abstract #IASHIV2021IAS_HIV_958;
No unexpected or concerning metabolic or bone effects were observed in treatment-naive adults living with HIV-1 receiving ISL+DOR. Due to small sample size in this trial, clinical significance will be further investigated in phase 3 clinical studies.
- ||| doravirine/islatravir (MK-8591A) / Merck (MSD)
So your concern i imagine is more around Doravirine's barrier of resistance? Because i imagine both doravirine and islatravir have far higher barrier than nrtis and still we see duals with insti + nrti. Unless you doubt about those too so fair enough 😀 (Twitter) - May 15, 2021
- || Clinical, Review, Journal: Risks and benefits of reducing the number of drugs to treat HIV-1 infection. (Pubmed Central) - Apr 30, 2021
Some two-drug regimens, especially those including maraviroc, have not been as successful. Long-term safety issues of these two-drug regimens remain to be determined, but with the overwhelming evidence available in virological control and short-term safety compared to three-drug regimens, the potential benefits of some of these two-drug regimens appear to outweigh the risks.
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (clinicaltrials.gov) - Apr 28, 2021
P3, N=578, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Long-term safety issues of these two-drug regimens remain to be determined, but with the overwhelming evidence available in virological control and short-term safety compared to three-drug regimens, the potential benefits of some of these two-drug regimens appear to outweigh the risks. Trial completion date: Aug 2022 --> Aug 2023