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- Idvynso (doravirine/islatravir) / Merck (MSD)
Switching to doravirine/Islatravir (100/0.25mg) once daily maintained viral suppression at week 96 in the presence of baseline NNRTI resistance-associated mutations and/or M184I/V in proviral DNA (101A) - Jun 26, 2026 - Abstract #AIDS2026AIDS_3703;
P3
Participants with HIV-1 RNA <50 copies/mL and no history of virologic failure or documented DOR resistance at baseline were randomized (2:1) to switch to DOR/ISL 100/0.25mg once-daily or to continue baseline ART (bART; P051) or BIC/FTC/TAF (P052). Switching to DOR/ISL 100/0.25mg in Phase 3 clinical studies maintained viral suppression at W96 despite the presence of baseline NNRTI RAMs or M184I/V in proviral DNA.
- Idvynso (doravirine/islatravir) / Merck (MSD)
Simplification to single-tablet doravirine/islatravir from complex antiretroviral regimens: subgroup analysis from a randomized, open-label, phase 3 clinical study () - Jun 26, 2026 - Abstract #AIDS2026AIDS_3652;
P3
Switching to DOR/ISL 100/0.25mg in Phase 3 clinical studies maintained viral suppression at W96 despite the presence of baseline NNRTI RAMs or M184I/V in proviral DNA. Among virologically suppressed adults with HIV-1 receiving complex ART regimens, simplification to single-tablet DOR/ISL (100/0.25mg) maintained virologic suppression in >96% of participants and was generally well-tolerated through W48.
- Idvynso (doravirine/islatravir) / Merck (MSD)
Community-led patent opposition case-study for HIV treatment access in Georgia (Poster Board Number 616) - May 2, 2026 - Abstract #AIDS2026AIDS_2962;
TBpeople Georgia submitted patent opposition filings against key antiretroviral drug patents (e.g., lopinavir/ritonavir, Islatravir and Doravirine), prepared proposal on legislative amendments on restricting of subject matter of protection of utility model patents that could limit competition and inflate treatment costs. The Georgian experience demonstrates that practice of a request to re-examine the Georgian ever greening patent for lopinavir/ritonavir opens a door for future similar actions on medicine access and affordability, initiated by community based organizations.
- Idvynso (doravirine/islatravir) / Merck (MSD)
Efficacy and safety by subgroup of doravirine/islatravir (100 mg/0.25 mg) once daily as initial HIV-1 therapy: week 48 results from a randomized, active-controlled phase 3 study (Poster Board Number 089) - May 2, 2026 - Abstract #AIDS2026AIDS_1326;
P3
Table 1. P053 efficacy (HIV RNA <50 copies/mL) at Week 48 (FDA snapshot approach) by subgroup Subgroup DOR/ISL n/N (%) BIC/FTC/TAF n/N (%) Difference in Percent Response (95% CI) All participants 247/269 (91.8) 242/267 (90.6) 1.2 (-3.7 to 6.1) Age 18 to 49 years =50 years 225/242 (93.0) 22/27 (81.5) 224/247 (90.7) 18/20 (90.0) 2.3 (-2.7 to 7.3) -8.5 (-29.2 to 14.6) Sex Male Female 189/204 (92.6) 58/65 (89.2) 180/198 (90.9) 62/69 (89.9) 1.7 (-3.8 to 7.4) -0.6 (-11.9 to 10.4) Race White Black or African American Asian Other a 103/110 (93.6) 78/89 (87.6) 27/29 (93.1) 36/38 (94.7) 106/115 (92.2) 73/82 (89.0) 28/29 (96.6) 33/38 (86.8) 1.5 (-5.8 to 8.7) -1.4 (-11.4 to 8.8) -3.4 (-19.2 to 11.4) 7.9 (-6.2 to 23.1) Ethnicity Hispanic or Latino/a Not Hispanic or Latino/a 98/104 (94.2) 146/162 (90.1) 99/110 (90.0) 142/156 (91.0) 4.2 (-3.3 to 12.1) -0.9 (-7.6 to 5.8) Region North America Europe Latin America Asia/Pacific Africa 49/58 (84.5) 47/49 (95.9) 60/63 (95.2) 37/41 (90.2) 54/58 (93.1) 52/57 (91.2) 44/50 (88.0) 66/73 (90.4) 30/33 (90.9) 50/54 (92.6) -6.7 (-19.6 to 5.7) 7.9 (-3.4 to 20.4) 4.8 (-4.8 to 14.5) -0.7 (-15.2 to 15.3) 0.5 (-10.2 to 11.7) BIC/FTC/TAF, bictegravir/emtricitabine/tenofovir alafenamide; DOR/ISL, doravirine/islatravir; FDA, US Food and Drug Administration; P053, MK-8591A-053 study.
- Idvynso (doravirine/islatravir) / Merck (MSD)
Open-label Phase 1 study to evaluate relative bioavailability and food effect on the pharmacokinetics of the fixed-dose combination of doravirine/islatravir (100 mg/0.25 mg) in adults without HIV () - May 2, 2026 - Abstract #AIDS2026AIDS_680;
P1
Administration of DOR/ISL following a high-fat meal does not have a clinically meaningful effect on DOR or ISL PK, which supports its administration without regard to food. Table.
- || Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion: A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (clinicaltrials.gov) - Feb 20, 2026
P1, N=12, Completed, Sponsor: Merck Sharp & Dohme LLC
Table. Active, not recruiting --> Completed
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and Safety of Doravirine/Islatravir (100/0.25 mg) in Adults With HIV and Renal Impairment (Poster Hall) - Feb 17, 2026 - Abstract #CROI2026CROI_853;
- || Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (clinicaltrials.gov) - Jan 23, 2026
P1, N=12, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Completed --> Active, not recruiting
- | doravirine/islatravir (MK-8591A) / Merck (MSD)
Journal: Doravirine/islatravir for heavily treatment-experienced adults with HIV: promise interrupted. (Pubmed Central) - Dec 29, 2025
Completed --> Active, not recruiting No abstract available
- || Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion, Trial completion date, Trial primary completion date: A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (clinicaltrials.gov) - Dec 18, 2025
P1, N=12, Completed, Sponsor: Merck Sharp & Dohme LLC
No abstract available Recruiting --> Completed | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: Jun 2026 --> Dec 2025
- |||| 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) - Nov 17, 2025
P3, N=2000, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Completed | Trial completion date: Jun 2026 --> Dec 2025 | Trial primary completion date: Jun 2026 --> Dec 2025 Trial completion date: May 2028 --> May 2029 | Trial primary completion date: May 2028 --> May 2029
- || Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment open: A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (clinicaltrials.gov) - Oct 6, 2025
P1, N=12, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: May 2028 --> May 2029 | Trial primary completion date: May 2028 --> May 2029 Not yet recruiting --> Recruiting
- ||| doravirine/islatravir (MK-8591A) / Merck (MSD)
P3 data, Journal, Head-to-Head: Doravirine/islatravir (100/0.75 mg) once-daily compared to bictegravir/emtricitabine/tenofovir alafenamide as initial HIV-1 treatment: 48-week results from a phase 3, randomized, controlled, double-blind, non-inferiority trial. (Pubmed Central) - Sep 19, 2025
P3
Doravirine/islatravir (100/0.75 mg) once-daily was noninferior to bictegravir/emtricitabine/tenofovir alafenamide through week 48 for initial HIV-1 treatment. Due to decreases in CD4 and lymphocyte counts, development of this dose of doravirine/islatravir was stopped.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Switching to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily Maintains Viral Suppression Through Week 48 in the Presence of Archived NNRTI Resistance-Associated Mutations or M184I/V in Proviral DNA (Poster Hall B4-B5; Virtual) - Sep 3, 2025 - Abstract #IDWeek2025IDWeek_946;
P3
Participants with HIV-1 RNA < 50 copies/mL and no known treatment failure or documented DOR resistance were randomized (2:1) to switch to DOR/ISL (100/0.25mg) once-daily or to continue baseline antiretroviral therapy (bART) in P051 or BIC/FTC/TAF in P052. Preexisting NNRTI RAMs or M184I/V in proviral DNA did not impact virologic suppression through Week 48 in participants switching to DOR/ISL (100/0.25mg) in Phase 3 clinical studies.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and Safety by Age After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results from Two Phase 3 Randomized, Active-Controlled Studies in Adults Living with HIV-1 (Poster Hall B4-B5; Virtual) - Sep 3, 2025 - Abstract #IDWeek2025IDWeek_909;
P3
In two Phase 3 studies, switching to DOR/ISL was non-inferior for efficacy with a safety profile comparable to continuing baseline antiretroviral therapy (bART) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) at Week 48 (W48). At W48, switching to DOR/ISL (100
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Safety and Efficacy of Doravirine/Islatravir (DOR/ISL) 100/0.25 mg Once Daily (QD) after ISL Dose Reduction from 0.75 mg: Week 48 Results from an Open-Label Phase 3 Study (Poster Hall B4-B5; Virtual) - Sep 3, 2025 - Abstract #IDWeek2025IDWeek_906;
P3
DOR/ISL 100/0.25 mg QD was generally well tolerated and maintained virologic suppression in a high proportion of participants who had previously received DOR/ISL 100/0.75 mg. Baseline total lymphocyte and CD4+ T-cell counts increased after ISL dose reduction.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and Safety by Sex Assigned at Birth After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results from Two Phase 3 Randomized, Active-Controlled Studies in Adults Living with HIV-1 (Poster Hall B4-B5; Virtual) - Sep 3, 2025 - Abstract #IDWeek2025IDWeek_901;
P3
Baseline total lymphocyte and CD4+ T-cell counts increased after ISL dose reduction. Background: In two Phase
- |||| 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) - Aug 5, 2025
P3, N=2000, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Background: In two Phase Trial completion date: Oct 2027 --> May 2028 | Trial primary completion date: Oct 2027 --> May 2028
- || Idvynso (doravirine/islatravir) / Merck (MSD)
New P1 trial: A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (clinicaltrials.gov) - Jul 26, 2025
P1, N=12, Not yet recruiting, Sponsor: Merck Sharp & Dohme LLC
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Evaluation of Fasting Lipids and Insulin Resistance After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily: Week 48 Results From Two Randomized Phase 3 Studies in Adults Living With HIV-1 (ePoster Exhibition; ePoster Station 1) - Jul 16, 2025 - Abstract #EACS2025EACS_900;
- Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) / Gilead, doravirine/islatravir (MK-8591A) / Merck (MSD)
Weight and Body Composition After Switch to Doravirine/Islatravir (100 mg/0.25 mg) Once Daily from BIC/FTC/TAF in Adults Living With HIV-1: Week 48 Results From a Randomized, Double-Blind Phase 3 Study (Grand Amphitheatre) - Jul 16, 2025 - Abstract #EACS2025EACS_613;
- | Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
Preclinical, Journal: Combined doravirine and islatravir cooperate to inhibit NRTI and NNRTI resistant HIV-1 in vitro. (Pubmed Central) - May 30, 2025
MuSyC scores showed a negative correlation with doravirine FC values, number of NRTI mutations and presence of M184V/I, but not with islatravir FC values. Doravirine and islatravir may cooperatively inhibit NRTI and NNRTI resistant viruses despite complex mutational profiles, however the accumulation of resistance mutations may reduce the combinatorial activity.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Switching to Doravirine/Islatravir (100 mg/0.25 mg) once daily maintained viral suppression in the presence of archived M184I/V resistance-associated mutations in proviral DNA () - May 10, 2025 - Abstract #IASHIV2025IAS_HIV_646;
P3
BACKGROUND: In three Phase 3 studies (P051: NCT05631093; P052: NCT05630755; P054: NCT05766501) virologic suppression was maintained in people living with HIV who switched to doravirine/islatravir (DOR/ISL 100 mg/0.25 mg); 2 studies (P051 and P052) were comparative and demonstrated noninferiority to baseline antiretroviral therapy (bART) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Switching to DOR/ISL 100 mg/0.25 mg in Phase 3 clinical studies maintained viral suppression for at least 48 weeks in the presence of preexisting M184I/V in proviral DNA.
- ||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion: 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) - Mar 31, 2025
P3, N=643, Completed, Sponsor: Merck Sharp & Dohme LLC
Switching to DOR/ISL 100 mg/0.25 mg in Phase 3 clinical studies maintained viral suppression for at least 48 weeks in the presence of preexisting M184I/V in proviral DNA. Active, not recruiting --> Completed
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Switch to DOR/ISL (100/0.25 mg) QD From Oral ART: An Open-Label Phase III Study in Adults With HIV-1 (San Francisco Ballroom B) - Mar 3, 2025 - Abstract #CROI2025CROI_332;
P3
MK-8591A-051 is a phase 3 study evaluating the efficacy and safety of switching from oral ART to DOR/ISL (100/0.25 mg), a once-daily single-tablet regimen...Conclusions Switching to DOR/ISL (100/0.25 mg) maintained viral suppression and was non-inferior to continuing bART at week 48. DOR/ISL was well tolerated with a similar safety profile to bART and did not adversely affect lymphocytes.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Switch to DOR/ISL (100/0.25 mg) QD From BIC/FTC/TAF: A Blinded Phase III Study in Adults With HIV-1 (San Francisco Ballroom B) - Mar 3, 2025 - Abstract #CROI2025CROI_331;
P3
Conclusions DOR/ISL (100/0.25 mg) maintained viral suppression and was non-inferior to BIC/FTC/TAF at week 48. DOR/ISL was well tolerated with a similar safety profile to BIC/FTC/TAF and did not adversely affect lymphocytes.
- ||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion: Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Na (clinicaltrials.gov) - Feb 24, 2025
P3, N=599, Completed, Sponsor: Merck Sharp & Dohme LLC
DOR/ISL was well tolerated with a similar safety profile to BIC/FTC/TAF and did not adversely affect lymphocytes. Active, not recruiting --> Completed
- || doravirine/islatravir (MK-8591A) / Merck (MSD)
Review, Journal: Doravirine/Islatravir for the treatment of HIV. (Pubmed Central) - Jan 3, 2025
ISL doses as low as 0.25?mg proved non-inferior to current treatments. Therefore, evaluation of the long-term efficacy and safety of DOR/ISL should focus on reduced doses of ISL and minimizing CD4 reduction.
- || Idvynso (doravirine/islatravir) / Merck (MSD)
New P1 trial: A Study of Doravirine and Islatravir as a Single Entity or Combination Therapy and the Effect of Food in Healthy Adult Participants (MK-8591A-055) (clinicaltrials.gov) - Dec 6, 2024
P1, N=24, Completed, Sponsor: Merck Sharp & Dohme LLC
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) - Oct 21, 2024
P3, N=500, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Therefore, evaluation of the long-term efficacy and safety of DOR/ISL should focus on reduced doses of ISL and minimizing CD4 reduction. Recruiting --> Active, not recruiting
- ||||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion: Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (clinicaltrials.gov) - Sep 27, 2024
P3, N=672, Completed, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: DOR/ISL in HIV-1 Antiretroviral Treatment-na (clinicaltrials.gov) - Sep 20, 2024
P3, N=500, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed Trial completion date: Nov 2026 --> Aug 2029
- doravirine/islatravir (MK-8591A) / Merck (MSD)
The Effect of Pantoprazole on Doravirine/Islatravir Pharmacokinetics (Halls JK) - Sep 4, 2024 - Abstract #IDWeek2024IDWEEK_2820;
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: 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) - Sep 2, 2024
P3, N=650, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Nov 2026 --> Aug 2029 Trial completion date: Jan 2026 --> Sep 2028
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: 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) - Aug 27, 2024
P3, N=514, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Jan 2026 --> Sep 2028 Trial completion date: Oct 2025 --> Aug 2028
- ||| Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion date: 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) - Aug 22, 2024
P3, N=501, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Oct 2025 --> Aug 2028 Trial completion date: Oct 2025 --> Jul 2028
- | Journal: Challenges for novel antiretroviral development in an era of widespread TLD availability. (Pubmed Central) - Jul 11, 2024
We illustrate when generic TLD will become available worldwide and compare this with trial programmes and approval timelines for two case-study novel ART combinations: islatravir/doravirine and cabotegravir/rilpivirine. We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD.
- ||| P3 data, Journal, Head-to-Head: Switch to fixed-dose doravirine (100 mg) with islatravir (0 (Pubmed Central) - May 30, 2024
P3
We demonstrate that currently these regimens and trial programmes will not meet key benchmarks required to compete with TLD. Switching to daily doravirine (100 mg) and islatravir (0
- ||| Pifeltro (doravirine) / Merck (MSD), doravirine/islatravir (MK-8591A) / Merck (MSD), islatravir (MK-8591) / Merck (MSD)
P3 data, Journal, Head-to-Head: Switch to fixed-dose doravirine (100 mg) with islatravir (0 (Pubmed Central) - May 30, 2024
P3
Switching to daily doravirine (100 mg) and islatravir (0 Switching to single-tablet doravirine (100 mg) and islatravir (0
- ||| 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) - Mar 28, 2024
P3, N=672, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Switching to single-tablet doravirine (100 mg) and islatravir (0 Trial completion date: Mar 2024 --> Nov 2024
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Switching to Doravirine/Islatravir Maintains Viral Suppression Regardless of Archived Mutations (Poster hall) - Mar 16, 2024 - Abstract #CROI2024CROI_1304;
P3
Background: In 2 phase 3 clinical trials, switching to the 2-drug combination doravirine/islatravir (DOR/ISL) 100/0.75mg was non-inferior to continuing the prior antiretroviral (ART) regimen. Switching to DOR/ISL 100/0.75mg maintains viral suppression for up to 96 weeks regardless of archived M184I/V or NNRTI RAMs in proviral DNA.
- |||| 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 5, 2024
P3, N=2000, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Switching to DOR/ISL 100/0.75mg maintains viral suppression for up to 96 weeks regardless of archived M184I/V or NNRTI RAMs in proviral DNA. Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027
- ||| 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) - Mar 3, 2024
P3, N=643, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Oct 2027 Trial completion date: May 2024 --> Feb 2025
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: 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) - Jan 4, 2024
P3, N=650, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Trial completion date: May 2024 --> Feb 2025 Recruiting --> Active, not recruiting
- || Idvynso (doravirine/islatravir) / Merck (MSD)
Trial completion: 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 8, 2023
P3, N=35, Completed, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment change: 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) - Nov 15, 2023
P3, N=650, Recruiting, Sponsor: Merck Sharp & Dohme LLC
Active, not recruiting --> Completed N=1300 --> 650
- ||||| Idvynso (doravirine/islatravir) / Merck (MSD)
Enrollment closed: 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) - Nov 7, 2023
P3, N=2000, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
N=1300 --> 650 Recruiting --> Active, not recruiting
- ||||| 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 Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) (clinicaltrials.gov) - Oct 12, 2023
P3, N=501, Active, not recruiting, Sponsor: Merck Sharp & Dohme LLC
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and safety by subgroup at week 48 after switch to doravirine/islatravir (100 mg/0.75 mg) once daily in two phase 3 trials (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_630;
P3
There were no clinically meaningful differences between treatment groups in the safety profile of P018 based on age, sex, race, or region. The higher rates of AEs in certain P017 DOR/ISL (100 mg/0.75 mg) subgroups can likely be attributed to the open-label study design.
- doravirine/islatravir (MK-8591A) / Merck (MSD)
Efficacy and safety by subgroup at week 48 after switch to doravirine/islatravir (100 mg/0.75 mg) once daily in two phase 3 trials (ePosters) - Oct 8, 2023 - Abstract #EACS2023EACS_629;
P3
There were no clinically meaningful differences between treatment groups in the safety profile of P018 based on age, sex, race, or region. The higher rates of AEs in certain P017 DOR/ISL (100 mg/0.75 mg) subgroups can likely be attributed to the open-label study design.