Expert Analysis
Expert Analysis: Insights for International Clinicians on New Data From HIV Glasgow 2020

Released: November 06, 2020

Expiration: November 05, 2021

Marina Klein
Marina Klein, MD, MSc, FRCP(C)
Jean-Michel Molina
Jean-Michel Molina, MD, PhD

Activity

Progress
1
Course Completed

References

  1. ClinicalTrials.gov. A phase III, randomised, double blind, multicentre, parallel group, non inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in human immunodeficiency virus 1 infected treatment naive adults. Available at: https://clinicaltrials.gov/ct2/show/NCT02831673. Accessed November 2, 2020.
  2. ClinicalTrials.gov. A phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naive adults. Available at: https://clinicaltrials.gov/ct2/show/NCT02831764. Accessed November 2, 2020.
  3. Cahn P, Sierra Madero J, Arribas JR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393:143-155.
  4. Cahn P, Sierra Madero J, Arribas JR, et al. Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-naive adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune Defic Syndr. 2020;83:310-318.
  5. Cahn P, Sierra-Madero J, Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection: 3-year results from the GEMINI studies. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract P018.
  6. Underwood M, Wang R, Benson P, et al. DTG + 3TC vs DTG + TDF/FTC (GEMINI-1 & -2): confirmed virologic withdrawals through week 96. Program and abstracts of the 2020 Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, Massachusetts. Abstract 483.
  7. van Wyk JA, Man CY, Sievers J, et al. Durable efficacy of two-drug regimen (2DR) of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naive adults with HIV-1 infection at 96 weeks: subgroup analyses in the GEMINI studies. Program and abstracts of IDWeek 2019; October 2-6, 2019; Washington, DC. Abstract 2842.
  8. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. Accessed November 2, 2020.
  9. Saag MS, Gandhi RT, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2020 recommendations of the International Antiviral Society–USA Panel. JAMA. 2020;324:1651-1669.
  10. European AIDS Clinical Society. EACS guidelines version 10.1. Available at: https://www.eacsociety.org/files/guidelines-10.1.finalsept2020.pdf. Accessed November 2, 2020.
  11. Venter F, Moorhouse M, Sokhela S, et al. The ADVANCE trial: phase 3, randomised comparison of TAF/FTC+DTG, TDF/FTC+DTG or TDF/FTC/EFV for first-line treatment of HIV-1 infection. Program and abstracts of the 23rd International AIDS Conference Virtual; July 6-10, 2020. Abstract OAXLB0104.
  12. Dolutegravir/lamivudine package insert. Research Triangle Park, NC: ViiV Healthcare; 2020.
  13. ClinicalTrials.gov. A phase III, randomized, multicenter, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus lamivudine in HIV-1 infected adults who are virologically suppressed. Available at: https://clinicaltrials.gov/ct2/show/NCT03446573. Accessed November 2, 2020.
  14. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG+3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 24 weeks (TANGO study). Program and abstracts of the 10th IAS Conference on HIV Science; July 21-24, 2019; Mexico City, Mexico. Abstract WEAB0403LB.
  15. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 96 weeks (TANGO study). Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O441.
  16. Cohen MS, Chen YQ, McCauley M, et al. Antiretroviral therapy for the prevention of HIV-1 transmission. N Engl J Med. 2016;375:830-839.
  17. Rodger AJ, Cambiano V, Bruun T, et al. Sexual activity without condoms and risk of HIV transmission in serodifferent couples when the HIV-positive partner is using suppressive antiretroviral therapy. JAMA. 2016;316:171-181.
  18. Bavinton BR, Pinto AN, Phanuphak N, et al. Viral suppression and HIV transmission in serodiscordant male couples: an international, prospective, observational, cohort study. Lancet HIV. 2018;5:e438-e447.
  19. Rodger AJ, Cambiano V, Bruun T, et al. Risk of HIV transmission through condomless sex in serodifferent gay couples with the HIV-positive partner taking suppressive antiretroviral therapy (PARTNER): final results of a multicentre, prospective, observational study. Lancet. 2019;393:2428-2438.
  20. Cingolani A, Tavelli A, Calvino G, et al. Awareness and perception of accuracy of the Undetectable=Untransmittable (U=U) message in people living with HIV/AIDS (PLWHA) in Italy and correlation with the level of confidence in reference physicians. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract P103.
  21. Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. 2020;382:1124-1135.
  22. D’Amico R, Orkin C, Bernal Morell E, et al. Safety and efficacy of cabotegravir + rilpivirine long-acting with and without oral lead-in: FLAIR Week 124 results. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O414.
  23. Trezza C, Ford SL, Spreen W, et al. Formulation and pharmacology of long-acting cabotegravir. Curr Opin HIV AIDS. 2015;10:239-245.
  24. Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. 2020;382:1112-1123.
  25. Overton ET, Richmond GJ, Rizzardini G, et al. Cabotegravir + rilpivirine every 2 months is noninferior to monthly: ATLAS-2M study. Program and abstracts of the 2020 Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, Massachusetts. Abstract 34.
  26. Margolis D, Schapiro J, Perno C, et al. A combination of viral and participant factors influence virologic outcome to long-acting cabotegravir and rilpivirine: multivariable and baseline factor analyses across ATLAS, FLAIR, and ATLAS-2M phase III studies. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O442.
  27. ClinicalTrials.gov. A phase 2b, randomized, double-blind, active-comparator-controlled, dose-ranging clinical trial to evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of MK-8591 given in combination with doravirine (DOR) and lamivudine (3TC) in HIV-1-infected treatment-naïve adults. Available at: https://clinicaltrials.gov/ct2/show/NCT03272347. Accessed November 2, 2020.
  28. Molina J, Yazdanpanah Y, Afani Saud A, et al. Islatravir in combination with doravirine maintains HIV-1 viral suppression through 96 weeks. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O415.
  29. ClinicalTrials.gov. A phase 3 randomized, active-controlled, double-blind clinical study to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir once-daily in HIV-1 infected treatment-naive participants. Available at: https://clinicaltrials.gov/ct2/show/NCT04233879. Accessed November 2, 2020.
  30. ClinicalTrials.gov. A study to evaluate the safety, tolerability, pharmacokinetics and antiretroviral activity of MK-8507 in HIV-1 infected patients. Available at: https://clinicaltrials.gov/ct2/show/NCT02174159. Accessed November 2, 2020.
  31. Ankrom W, Schuermann D, Jackson Rudd D, et al. Single doses of MK-8507, a novel HIV-1 NNRTI, reduced HIV viral load for at least a week. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O416.
  32. Stanford University HIV Drug Resistance Database. NNRTI resistance notes. Available at: https://hivdb.stanford.edu/dr-summary/resistance-notes/NNRTI/. Accessed October 28, 2020.
  33. Pham HT, Xiao MA, Principe MAV, et al. Pharmaceutical, clinical, and resistance information on doravirine, a novel non-nucleoside reverse transcriptase inhibitor for the treatment of HIV-1 infection. Drugs Context. 2020;9:2019-11-4.
  34. ClinicalTrials.gov. A phase 2b, randomized, active-controlled, double-blind, dose-ranging clinical study to evaluate a switch to islatravir (ISL) and MK-8507 once-weekly in adults with HIV-1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily. Available at: https://clinicaltrials.gov/ct2/show/NCT04564547. Accessed November 2, 2020.
  35. ClinicalTrials.gov. A phase 1b randomized, double-blinded, placebo controlled, multi-cohort study of the safety, pharmacokinetics, and antiviral activity of GS-6207 administered subcutaneously in HIV-1 infected subjects. Available at: https://clinicaltrials.gov/ct2/show/NCT03739866. Accessed November 2, 2020.
  36. Margot N, Ram R, Parvangada P, et al. Lenacapavir resistance analysis in a phase Ib clinical proof-of-concept study. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O324.
  37. Daar E, McDonald C, Crofoot G, et al. Dose-response relationship of subcutaneous long-acting HIV capsid inhibitor GS-6207. Program and abstracts of the 2020 Conference on Retroviruses and Opportunistic Infections; March 8-11, 2020; Boston, Massachusetts. Abstract 469.
  38. ClinicalTrials.gov. A phase 2 randomized, open label, active controlled study evaluating the safety and efficacy of long-acting capsid inhibitor GS-6207 in combination with other antiretroviral agents in people living with HIV. Available at: https://clinicaltrials.gov/ct2/show/NCT04143594. Accessed November 2, 2020.
  39. Guaraldi G, Draisci S, Milic J, et al. Fat distribution and density in people living with HIV with ≥5% weight gain. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O111.
  40. Milic J, Cervo A, Carli F, et al. NAFLD with significant fibrosis in people living with HIV informs the natural history of cardiovascular disease. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract P074.
  41. Mocroft A, Petoumenos K, Wit F, et al. The relationship between smoking, CD4, viral load and cancer risk in HIV-positive adults. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O124.
  42. Geretti A, Stockdale A, Kelly S, et al. Outcomes of COVID-19 related hospitalisation among people with HIV in the United Kingdom and comparison to those without HIV. Program and abstracts of the 2020 International Congress on Drug Therapy in HIV Infection; October 5-8, 2020; Glasgow, United Kingdom. Abstract O422.