IMPAACT P1078 Results

Gerhard Theron, Grace Montepiedra, Lisa Aaron, Katie McCarthy, Chakhtoura Nahida, Patrick Jean-Philippe, Bonnie Zimmer, Amy James Loftis, Tsungai Chipato, Teacler Nematadzira, Mandisa Nyati, Carolyne Onyango-Makumbi, Gaerolwe Masheto, James Ngocho, Fuanglada Tongprasert, Sandesh Patil, Dominique Lespinasse, Adriana Weinberg, Amita Gupta, IMPAACT P1078 TB APPRISE Study Team. Individual and Composite Adverse Pregnancy Outcomes in a Randomized Trial on Isoniazid Preventative Therapy Among Women Living With HIV, Clinical Infectious Diseases, 2020 Sep 30. https://doi.org/10.1093/cid/ciaa1482.

Kamunkhwala Gausi, Lubbe Wiesner, Jennifer Norman, Carole L Wallis, Carolyne Onyango-Makumbi, Tsungai Chipato, David W Haas, Renee Browning, Nahida Chakhtoura, Grace Montepiedra, Lisa Aaron, Katie McCarthy, Sarah Bradford, Tichaona Vhembo, Lynda Stranix-Chibanda, Gaerolwe R Masheto, Avy Violari, Blandina T Mmbaga, Linda Aurpibul, Ramesh Bhosale, Neetal Nevrekhar, Vanessa Rouzier, Enid Kabugho, Mercy Mutambanengwe, Vongai Chanaiwa, Mandisa Nyati, Tsungai Mhembere, Fuanglada Tongprasert, Anneke Hesseling, Katherine Shin, Bonnie Zimmer, Diane Costello, Patrick Jean-Philippe, Timothy R Sterling, Gerhard Theron, Adriana Weinberg, Amita Gupta, Paolo Denti, IMPAACT P1078 (TB APPRISE) Study Group Team Pharmacokinetics and drug-drug interactions of isoniazid and efavirenz in pregnant women living with HIV in high TB incidence settings: importance of genotyping, Clinical Pharmacology & Therapeutics, 2020 Sep 9. doi: 10.1002/cpt.2044. Online ahead of print.

Weinberg A, Aaron L, Montepiedra G, Sterling TR, Browning R, Mmbaga B, Vhembo T, Naik S, Kabugho E, Masheto G, Pahwa S, Mathad JS, LaCourse SM, McCarthy K, Bradford S, Theron G, Costello D, Zimmer B, Pierre MF, Gausi K, Denti P, Haas DW, Gupta A, IMPAACT P1078 study team, Effects of Pregnancy and Isoniazid Preventive Therapy on M. tuberculosis Interferon Gamma Response Assays in Women with HIV, Clinical Infectious Diseases, ciaa1083, https://doi.org/10.1093/cid/ciaa1083

Gupta A, Aaron L, Theron G, McCarthy K, Bradford S, Chipato T, Vhembo T, Stranix-Chibanda L, Onyango-Makumbi C, Masheto G, Chakhtoura N, Jean-Philippe P, Browning R, Sterling T, Weinberg A, Montepiedra G, for the IMPAACT P1078 TB APPRISE Study Team. Risk factors for hepatotoxicity in HIV-infected women receiving isoniazid preventive therapy in pregnancy and postpartum. Oral presentation at the 23rd International AIDS Conference, Virtual, July 2020.

Theron G, Chakhtoura N, Montepiedra G, Aaron L, Jean-Philippe P, Weinberg A, McCarthy K, Nematadzira T, Masheto G, Chipato T, Onyango-Makumbi C, Gupta A, for the IMPAACT P1078 Team. Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV. Poster presentation at the 27th Conference on Retroviruses and Opportunistic Infections, Boston, Massachusetts, March 2020.

Gupta A, Montepiedra G, Aaron L, Theron G, McCarthy K, Bradford S, Chipato T, Vhembo T, Stranix-Chibanda L, Onyango-Makumbi C, Masheto GR, Violari A, Mmbaga BT, Aurpibul L, Bhosale R, Mave V, Rouzier V, Hesseling A, Shin K, Zimmer B, Costello D, Sterling TR, Chakhtoura N, Jean-Philippe P, Weinberg A, for the IMPAACT P1078, TB APPRISE (TB Ante vs. Postpartum Prevention with INH in HIV Seropositive Mothers and Their Exposed Infants) Study Team. Isoniazid preventive therapy in HIV-infected pregnant and postpartum women. N Engl J Med. 2019;381:1333-46.

Weinberg A, Aaron L, Montepiedra G, Sterling T, Chakhtoura N, Browning R, Mmbaga BT, Vhembo T, Naik S, Pahwa S, Mathad J, LaCourse S, McCarthy K, Bradford S, Theron G, Costello D, Zimmer B, Pierre MF, Gupta A, for the IMPAACT P1078 study team. Women Living with HIV (WLWH) Lose IFNγ Responses Diagnostic of Latent TB Infection (LTBI) during Pregnancy and after INH Prophylactic Treatment (IPT). Poster presentation at IDWeek, Washington, DC, United States, October 2019.

Gausi K, Denti P, Wiesner L, Wallis CL, Onyango-Makumbi C, Chipato T, Theron G, Haas DW, Sterling TR, Browning R, Chakhtoura N, Weinberg A, Montepiedra G, Gupta A, for the IMPAACT P1078 Study Group. Impact of isoniazid and pregnancy on efavirenz pharmacokinetics in women living with HIV. In: International AIDS Conference; 2019 Jul 21-24; Mexico City, Mexico.

Gausi K, Denti P, Weisner L, Wallis C, Onyango-Makumbi C, Chipato T, Theron G, Bradford S, Costello D, Browning R, Chakhtoura N, Weinberg A, Montepiedra G, Gupta A, and the IMPAACT P1078 (TB APPRISE) Study Group Team. Pregnancy is Associated with Decreased Serum Isoniazid Levels in Women Living with HIV. In: Conference on Retroviruses and Opportunistic Infections; 2019 Mar 4-7; Seattle, United States

Gausi K, Wiesner L, Norman J, Wallis CL, Onyango-Makumbi C, Chipato T, Theron G, Haas DW, Sterling TR, Browning R, Chakhtoura N, Weinberg A, Montepiedra G, Gupta A, Denti P and the IMPAACT P1078 (TB APPRISE) Study Group Team. Pharmacokinetics of isoniazid preventive therapy among HIV-infected pregnant women in high tuberculosis incidence settings. In: 28th Population Approach Group in Europe Meeting; 2019 Jun 11-14; Stockholm, Sweden. 

Gupta A, Aaron L, Montepiedra G, Theron G, Chipato T, Onyango-Makumbi C, Stranix-Chibanda L, Weinberg A, for the IMPAACT P1078/TB APPRISE Study Team. Impact of maternal IPT timing on acquisition of infant TB infection in the IMPAACT P1078 TB APPRISE trial. In: 49th Union World Conference on Lung Health; 2018 Oct 24-27; The Hague, The Netherlands.

P1078 Update by Amita Gupta, P1078 Protocol Chair. Maternal Isoniazid Preventive Therapy for Tuberculosis (TB) Prevention in High Burden TB/HIV Settings: Results of the IMPAACT P1078 Trial. In: IMPAACT Network Annual Meeting; 2018 Jun 16-19; Washington, D.C., United States.

P1078 at CROI 2018 – March 2018

Gupta A, Montepiedra G, Aaron L, Theron G, McCarthy K, Onyango-Makumbi C, Chipato T, Masheto G, Shin K, Zimmer B, Sterling TR, Chakhtoura N, Jean-Philippe P, Weinberg A, for the IMPAACT P1078//TB APPRISE Study Team. Randomized trial of safety of isoniazid preventive therapy during or after pregnancy. In: Conference on Retroviruses and Opportunistic Infections; 2018 Mar 5-7; Boston, United States.