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G BLICK1, E CERRETA-DIAL1, G MANCINI1, A COSENZA1, L. FANG2 1Health Care Advocates International, Stratford CT USA 2Pharstat, Raleigh, NC USA SSOAX0903LB No Confirmed Virological Failures (CVF) for 144 Weeks When Switching 2-3-4-Drug ART
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01
G BLICK1, E CERRETA-DIAL1, G MANCINI1, A COSENZA1, L. FANG2
1Health Care Advocates International, Stratford CT USA
2Pharstat, Raleigh, NC USA SSOAX0903LB No Confirmed Virological Failures (CVF) for 144 Weeks When Switching 2-/3-/4-Drug ART to DTG/3TC in Heavily Treatment-Experienced PLWHA with Prior M184V/I and Multiple Virological Failures in the Prospective SOLAR-3D Study<br>
1Health Care Advocates International, Stratford CT USA
2Pharstat, Raleigh, NC USA SSOAX0903LB No Confirmed Virological Failures (CVF) for 144 Weeks When Switching 2-/3-/4-Drug ART to DTG/3TC in Heavily Treatment-Experienced PLWHA with Prior M184V/I and Multiple Virological Failures in the Prospective SOLAR-3D Study<br>
02
SUMMARY 2 MAIN QUESTION:
Can you safely and effectively switch adult PLWHA “OFF-LABEL” to a 2DR STR DTG/3TC regimen in the setting of prior virologic failures and history of prior M184V/I? MAIN IMPORTANCE OF FINDINGS?
Why use 3- or 4-drug ART if 2DR does not sacrifice virologic efficacy?
“Less is better”: 2DR does not add short-term safety issues. ?Long-term impact of stopping ABC, TDF, or TAF?
Global financial impact: cost savings of 2DR is enormous in resource-limited and resource-wealthy nations MAIN FINDING:
Neither Prior or Current M184V/I nor history of prior ART virological failures impact the efficacy of switching virologically suppressed adult PLWHA to DTG/3TC through 144 weeks. MAIN IMPORTANCE OF FINDINGS:
Why use 3- or 4-drug ART if 2DR does not sacrifice virologic efficacy?
2DR does not add short-term safety issues. ?Positive long-term metabolic impact of stopping ABC, TDF, or TAF?
Global financial and health impacts: cost savings and potential human morbidity and mortality benefits of 2DR would be enormous in economically developed and developing nations Blick et al. IAS 2024, #SSOAX0903LB<br>
Can you safely and effectively switch adult PLWHA “OFF-LABEL” to a 2DR STR DTG/3TC regimen in the setting of prior virologic failures and history of prior M184V/I? MAIN IMPORTANCE OF FINDINGS?
Why use 3- or 4-drug ART if 2DR does not sacrifice virologic efficacy?
“Less is better”: 2DR does not add short-term safety issues. ?Long-term impact of stopping ABC, TDF, or TAF?
Global financial impact: cost savings of 2DR is enormous in resource-limited and resource-wealthy nations MAIN FINDING:
Neither Prior or Current M184V/I nor history of prior ART virological failures impact the efficacy of switching virologically suppressed adult PLWHA to DTG/3TC through 144 weeks. MAIN IMPORTANCE OF FINDINGS:
Why use 3- or 4-drug ART if 2DR does not sacrifice virologic efficacy?
2DR does not add short-term safety issues. ?Positive long-term metabolic impact of stopping ABC, TDF, or TAF?
Global financial and health impacts: cost savings and potential human morbidity and mortality benefits of 2DR would be enormous in economically developed and developing nations Blick et al. IAS 2024, #SSOAX0903LB<br>
03
BACKGROUND 3 1van Wyk J, et al. TANGO Study. Clin Infect Dis. 2020;71(8):1920-1929. 2Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. DHHS. Available at https://clinicalinfo.hiv.gov/sites/default/files/ guidelines/documents/ AdultandAdolescentGL.pdf. Accessed Oct 3, 2021, I31. 3European AIDS Clinical Society. EACS Guidelines Version 10.1, October 2020. Available online: https://www.eacsociety.org/files/guidelines-10.1_30032021_1.pdf. Accessed Oct 3, 2021. 4Rial-Crestelo, et al. J Antimicrob Chemother. 2021 Feb 11;76(3):738-742. 5Madhusudan K, et al. Open Forum Inf Dis. 2023 Nov 10(11), ofad526. 6Blick G et al. IAS2023, OAB0202. 7De Miguel Buckley R, et al. EACS 2023, eP.A.097. 8De Miguel R, et l. CROI 2024, 693.
§n=261 includes ART-PRO and SOLAR-3D patients Blick et al. IAS 2024, #SSOAX0903LB Dovato (Dolutegravir/Lamivudine, DTG/3TC) Indication: “…as a complete regimen in adults and adolescents…to replace current ART in those with [PCR<50 c/mL] on stable ART with no history of treatment failure (VF), no known resistance substitutions to [DTG or 3TC]”1-3. The majority of heavily treatment-experienced (HTE) PLWHA do not qualify for “on-label” switch to DTG/3TC”Unmet Need”
HCPs are hesitant to switch to DTG/3TC in virologically suppressed PLWHIV with “data lacking/insufficient” on switching to DTG/3TC in TE patients with history of past resistance (M184V/I, K65R) and/or VF.
Data in n=311: ART-PRO4 (n=41, 96w, 21 w/M184V/I), Metanalysis5 (n=1909, 48-96w, 261§ w/M184V/I), SOLAR-3D6 (n=100, 96w, 50 w/M184V/I), VOLVER(GESIDA 11820)7,8 (n=121, 48w, 121 w/M184V/I [confirmed, suspected]): switching to DTG/3TC can maintain virological suppression in 96-100% at 48-96w despite historical/current archived 3TC RAMs and prior VF.<br>
§n=261 includes ART-PRO and SOLAR-3D patients Blick et al. IAS 2024, #SSOAX0903LB Dovato (Dolutegravir/Lamivudine, DTG/3TC) Indication: “…as a complete regimen in adults and adolescents…to replace current ART in those with [PCR<50 c/mL] on stable ART with no history of treatment failure (VF), no known resistance substitutions to [DTG or 3TC]”1-3. The majority of heavily treatment-experienced (HTE) PLWHA do not qualify for “on-label” switch to DTG/3TC”Unmet Need”
HCPs are hesitant to switch to DTG/3TC in virologically suppressed PLWHIV with “data lacking/insufficient” on switching to DTG/3TC in TE patients with history of past resistance (M184V/I, K65R) and/or VF.
Data in n=311: ART-PRO4 (n=41, 96w, 21 w/M184V/I), Metanalysis5 (n=1909, 48-96w, 261§ w/M184V/I), SOLAR-3D6 (n=100, 96w, 50 w/M184V/I), VOLVER(GESIDA 11820)7,8 (n=121, 48w, 121 w/M184V/I [confirmed, suspected]): switching to DTG/3TC can maintain virological suppression in 96-100% at 48-96w despite historical/current archived 3TC RAMs and prior VF.<br>
04
4 RATIONALE If PCR<50 for years, M184V/I may no longer persist/be archived as minority variants in reservoirs, thus no longer clinically relevant regarding maintaining viral suppression9-12. There is a significant cost advantage to using 2-drug vs 3- or 4-drug ART that would positively impact both economically developed and developing nations14-16. DTG/3TC may have clinically relevant long-term safety advantages, especially in economically developing nations that continue to utilize TDF-based regimens13. 1Campbell, et al. Clin Infect Dis. 2005;41:236-242. 2Castagna, et al. AIDS. 2006;20:795. 3Paton, et al. NEJM. 2014;371:234. 4La Rosa, et al. Lancet HIV. 2016;3:e247. 5Boyd, et al. Lancet. 2013;382:664. 6Quercia R, et al. JAIDS. 2018;78(2):1-29. 7Turner D, et al. Clin Diag Lab Immun. 2003;10(6):979-981. 8 Quan Y, et al. Antimicrob Agents Chemother. 2003;47(2):747-754. 9Ciaffi, et al. Lancet HIV. 2017;4:e384. 10Wirden, et al. J Antimicrob Chemother. 2011;66:709. 11Delaugerre, et al. HIV Med. 2012;13:517. 12Allavena, et al. J Virol Methods. 2018;251:106. 13Cahn, et al. Lancet. 2019;393(10167):143-155. 14Girouard, et al. Clin Infect Dis. 2016;62(6):784-791. 15Priest, et al. Infect Dis Ther. 2023;12:2117-2133. 16Fan, et al. Value in Health. 2022;25(12):S132-S133. HIV-1 containing M184V/I displays reduced viral replication fitness/capacity6-8. In the setting of M184V/I, 3TC can still exert a modest antiviral effect (0.5 log10) in PLWHIV with VF1-6. Therefore, not “monotherapy". Blick et al. IAS 2024, #SSOAX0903LB<br>
05
STUDY DESIGN 5 ELIGIBILITY CRITERIA:
HIV+ Adults aged ≥18
HIV-1 RNA <50c/mL for ≥6mos
Any stable 2-/3-/4-drug ART for ≥6mos
Prior virologic failure (≥2 prior ART with at least 1 of following: failure to attain PCR<50, confirmed rebound PCR>200, documented genotypic/ phenotypic resistance)
No exclusion for prior INSTI, any CD4, prior NRTI mutations, or M184V/I or K65R in BL Proviral DNA NGS (above a 10% threshold)
COVID Window +/- 1mo. SOLAR-3D:
Prospective, open-label, comparative, 96-week study, [144-week extension] (n=100) HISTORY OF PRIOR M184V/I (n=50) NO HISTORY OF PRIOR M184V/I (n=50) PRIMARY ENDPOINTS:
Proportion of pts with PCR≥50 at Wks 48 & 96 (FDA Snapshot, ITT-E, Per Protocol)
SECONDARY ENDPOINTS:
PCR<50 at Wks 48 & 96 (FDA Snapshot, ITT-E and Per Protocol)
Discontinuations due to CVF (PCR≥50 followed by PCR>200) DAY 1 WEEK 12 WEEK 24 Primary Endpoints: Participants with PCR≥50 per FDA Snapshot (ITT-E, PP) WEEK 36 WEEK 48 WEEK 72 WEEK 96 WEEK 144 Individuals were consecutively consented and enrolled during regularly scheduled office appointments from 5/2/2019 through 6/16/2020 Blick et al. IAS 2024, #SSOAX0903LB WEEK 192<br>
HIV+ Adults aged ≥18
HIV-1 RNA <50c/mL for ≥6mos
Any stable 2-/3-/4-drug ART for ≥6mos
Prior virologic failure (≥2 prior ART with at least 1 of following: failure to attain PCR<50, confirmed rebound PCR>200, documented genotypic/ phenotypic resistance)
No exclusion for prior INSTI, any CD4, prior NRTI mutations, or M184V/I or K65R in BL Proviral DNA NGS (above a 10% threshold)
COVID Window +/- 1mo. SOLAR-3D:
Prospective, open-label, comparative, 96-week study, [144-week extension] (n=100) HISTORY OF PRIOR M184V/I (n=50) NO HISTORY OF PRIOR M184V/I (n=50) PRIMARY ENDPOINTS:
Proportion of pts with PCR≥50 at Wks 48 & 96 (FDA Snapshot, ITT-E, Per Protocol)
SECONDARY ENDPOINTS:
PCR<50 at Wks 48 & 96 (FDA Snapshot, ITT-E and Per Protocol)
Discontinuations due to CVF (PCR≥50 followed by PCR>200) DAY 1 WEEK 12 WEEK 24 Primary Endpoints: Participants with PCR≥50 per FDA Snapshot (ITT-E, PP) WEEK 36 WEEK 48 WEEK 72 WEEK 96 WEEK 144 Individuals were consecutively consented and enrolled during regularly scheduled office appointments from 5/2/2019 through 6/16/2020 Blick et al. IAS 2024, #SSOAX0903LB WEEK 192<br>
06
BASELINE CHARACTERISTICS 6 There were no significant differences observed for Age at time of HIV diagnosis, Race, HBV/HCV, Median highest PCR or History PCR>100,000c/mL Blick et al. IAS 2024, #SSOAX0903LB<br>
07
SWITCH CHARACTERISTICS 7 §1 pt with a screening PCR<50 was PCR 73 c/mL at BL; †1 pt with screening PCR<50 was PCR 4150 c/mL at BL 157.8 (153-171) 157.4 (153-171) 158.3 (152-171) Blick et al. IAS 2024, #SSOAX0903LB<br>
08
BASELINE ART AND PROVIRAL MUTATIONS 8 NGS = Next-Generation Sequence; Performed by Quest Diagnostics; Resistance-associated mutations present in 10% or more of viral species sequenced are reported Blick et al. IAS 2024, #SSOAX0903LB<br>
09
BASELINE ART AND PROVIRAL MUTATIONS 9 NGS = Next-Generation Sequence; Performed by Quest Diagnostics; Resistance-associated mutations present in 10% or more of viral species sequenced are reported Blick et al. IAS 2024, #SSOAX0903LB Prior 1st Generation INSTI Use During VF, n (%)
YES 34 (71.8) 25 (50)
NO 14 (29.2) 25 (50)
RAL (Raltegravir) 24 (70.6) 9 (36)
EVG (Elvitegravir)/r or EVG/c 8 (23.5) 15 (60)
Both RAL and EVG 2 (5.9) 1 (4) NRTI<br>
YES 34 (71.8) 25 (50)
NO 14 (29.2) 25 (50)
RAL (Raltegravir) 24 (70.6) 9 (36)
EVG (Elvitegravir)/r or EVG/c 8 (23.5) 15 (60)
Both RAL and EVG 2 (5.9) 1 (4) NRTI<br>
10
10 VIROLOGIC OUTCOMES: Primary Endpoints, 48 & 96W, and Week 144, ITT-E 100
80
60
40
20
10
0 WEEK 48 WEEK 96 PRIMARY ENDPOINTS, 48 & 96W
PCR ≥50c/mL by FDA Snapshot Patients (%) 2%
(1/50) 6%
(3/50) 4%
(2/50) 2%
(1/50) Historical M184V/I
No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB 100
80
60
40
20
10
0 WEEK 144 Historical M184V/I
No Historical M184V/I WEEK 144 EXTENSION
PCR ≥50c/mL by FDA Snapshot 4%
(2/50) 6%
(3/50) 2 / 2 re-suppressed 2 / 3 re-suppressed PCR≥50c/mL was similar in the two treatment arms, ITT-E<br>
80
60
40
20
10
0 WEEK 48 WEEK 96 PRIMARY ENDPOINTS, 48 & 96W
PCR ≥50c/mL by FDA Snapshot Patients (%) 2%
(1/50) 6%
(3/50) 4%
(2/50) 2%
(1/50) Historical M184V/I
No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB 100
80
60
40
20
10
0 WEEK 144 Historical M184V/I
No Historical M184V/I WEEK 144 EXTENSION
PCR ≥50c/mL by FDA Snapshot 4%
(2/50) 6%
(3/50) 2 / 2 re-suppressed 2 / 3 re-suppressed PCR≥50c/mL was similar in the two treatment arms, ITT-E<br>
11
11 VIROLOGIC OUTCOMES: Secondary Endpoints, 48 & 96W, and Week 144, ITT-E 100
80
60
40
20
10
0 100
80
60
40
20
10
0 WEEK 48 WEEK 96 SECONDARY ENDPOINTS, 48 & 96W
PCR <50c/mL by FDA Snapshot WEEK 144 EXTENSION
PCR <50c/mL by FDA Snapshot Patients (%) 92% 88% (46/50) (44/50) 84% 88% (42/50) (44/50) Historical M184V/I No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB Historical M184V/I No Historical M184V/I 74% (37/50) 72% (36/50) WEEK 144 PCR<50c/mL was similar in the two treatment arms, ITT-E<br>
80
60
40
20
10
0 100
80
60
40
20
10
0 WEEK 48 WEEK 96 SECONDARY ENDPOINTS, 48 & 96W
PCR <50c/mL by FDA Snapshot WEEK 144 EXTENSION
PCR <50c/mL by FDA Snapshot Patients (%) 92% 88% (46/50) (44/50) 84% 88% (42/50) (44/50) Historical M184V/I No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB Historical M184V/I No Historical M184V/I 74% (37/50) 72% (36/50) WEEK 144 PCR<50c/mL was similar in the two treatment arms, ITT-E<br>
12
12 VIROLOGIC OUTCOMES: Primary Endpoints, 48 & 96W, and Week 144, Per Protocol 100
80
60
40
20
10
0 100
80
60
40
20
10
0 WEEK 48 WEEK 96 PRIMARY ENDPOINTS, 48 & 96W
PCR ≥50c/mL by FDA Snapshot WEEK 144 EXTENSION
PCR ≥50c/mL by FDA Snapshot Patients (%) 2.1%
(1/47) 6.4%
(3/47) 4.6%
(2/44) 2.2%
(1/45) Historical M184V/I
No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB WEEK 144 Historical M184V/I
No Historical M184V/I 5.1%
(2/39) 7.7%
(3/39) PCR≥50c/mL was similar in the two treatment arms, PP<br>
80
60
40
20
10
0 100
80
60
40
20
10
0 WEEK 48 WEEK 96 PRIMARY ENDPOINTS, 48 & 96W
PCR ≥50c/mL by FDA Snapshot WEEK 144 EXTENSION
PCR ≥50c/mL by FDA Snapshot Patients (%) 2.1%
(1/47) 6.4%
(3/47) 4.6%
(2/44) 2.2%
(1/45) Historical M184V/I
No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB WEEK 144 Historical M184V/I
No Historical M184V/I 5.1%
(2/39) 7.7%
(3/39) PCR≥50c/mL was similar in the two treatment arms, PP<br>
13
13 VIROLOGIC OUTCOMES: Secondary Endpoints, 48 & 96W, and Week 144, Per Protocol 100
80
60
40
20
10
0 100
80
60
40
20
10
0 WEEK 48 WEEK 96 SECONDARY ENDPOINTS, 48 & 96W
PCR <50c/mL by FDA Snapshot WEEK 144 EXTENSION
PCR <50c/mL by FDA Snapshot Patients (%) Historical M184V/I No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB Historical M184V/I No Historical M184V/I 94.9% (37/39) 92.3% (36/39) WEEK 144 97.9% 93.6% (46/47) (44/47) 95.5% 97.8% (42/44) (44/45) PCR<50c/mL was similar in the two treatment arms, PP<br>
80
60
40
20
10
0 100
80
60
40
20
10
0 WEEK 48 WEEK 96 SECONDARY ENDPOINTS, 48 & 96W
PCR <50c/mL by FDA Snapshot WEEK 144 EXTENSION
PCR <50c/mL by FDA Snapshot Patients (%) Historical M184V/I No Historical M184V/I Blick et al. IAS 2024, #SSOAX0903LB Historical M184V/I No Historical M184V/I 94.9% (37/39) 92.3% (36/39) WEEK 144 97.9% 93.6% (46/47) (44/47) 95.5% 97.8% (42/44) (44/45) PCR<50c/mL was similar in the two treatment arms, PP<br>
14
14 VIROLOGIC DISPOSITIONS: Week 144, ITT-E Population §8 deaths unrelated to study drug: 1-Week 33 (69yo) cardiac arrhythmia/cardiomyopathy, 1-Week 42 (52yo) from cardiorespiratory arrest, 1-Week 92 (71yo) from hemorrhagic stroke, 1-Week 147 (59yo) anal carcinoma, 1-Week 141 (74yo) CHF, 1-Week 133 (48yo) Methamphetamine overdose, 1-Week 118 (73yo) CKD, 1-Week 137 (62yo) cardiac arrhythmia/CHF; †2 deaths unrelated to study drug: 1-Week 48 from suicide, 1-Week 91 died in sleep at home/? suicide Blick et al. IAS 2024, #SSOAX0903LB<br>
15
VIROLOGIC FAILURES: Secondary Endpoint, Week 144 15 There were no cases of Confirmed Virologic Failure (CVF)§ in Historical M184VI treatment arm
1 CVF in No Historical M184V/I treatment arm through Week 144, due to non-adherence
There were no cases of Treatment-Emergent Resistance across treatment arms through Week 144 §Confirmed Virologic Failure (CVF) is defined as a PCR≥50 followed by a second consecutive PCR>200 Blick et al. IAS 2024, #SSOAX0903LB<br>
1 CVF in No Historical M184V/I treatment arm through Week 144, due to non-adherence
There were no cases of Treatment-Emergent Resistance across treatment arms through Week 144 §Confirmed Virologic Failure (CVF) is defined as a PCR≥50 followed by a second consecutive PCR>200 Blick et al. IAS 2024, #SSOAX0903LB<br>
16
16 VIRAL LOAD “Blips”: Through Week 144, Per Protocol 10
8
6
4
2
0 Patients (%) WEEK 12 WEEK 24 WEEK 36 WEEK 48 WEEK 72 WEEK 96 6.4% 4.1% 6.1% 8.2% 4.3% 6.3% 2.1% 6.4% 0% 4.5% 5.1% 2.2% 3/47 2/49 3/49 4/49 2/47 3/48 1/47 2/44 1/45 2/39 0/38 Historical M184V/I
No Historical M184V/I A viral load “blip” was defined as a viral load of 50 to <200 c/mL that resuppressed with adjacent PCR <50 c/mL Blick et al. IAS 2024, #SSOAX0903LB 3/47 WEEK 144 5.1% 5.1% 2/39 2/39 The occurrences of “blips” by visit were similar across treatment arms; HIV-1 RNA resuppressed in all M184V/I patients<br>
8
6
4
2
0 Patients (%) WEEK 12 WEEK 24 WEEK 36 WEEK 48 WEEK 72 WEEK 96 6.4% 4.1% 6.1% 8.2% 4.3% 6.3% 2.1% 6.4% 0% 4.5% 5.1% 2.2% 3/47 2/49 3/49 4/49 2/47 3/48 1/47 2/44 1/45 2/39 0/38 Historical M184V/I
No Historical M184V/I A viral load “blip” was defined as a viral load of 50 to <200 c/mL that resuppressed with adjacent PCR <50 c/mL Blick et al. IAS 2024, #SSOAX0903LB 3/47 WEEK 144 5.1% 5.1% 2/39 2/39 The occurrences of “blips” by visit were similar across treatment arms; HIV-1 RNA resuppressed in all M184V/I patients<br>
17
17 VIRAL LOAD Target Not Detected (TND): Through Week 144, ITT-E 100
80
60
40
20
0 Patients (%) WEEK 12 WEEK 24 WEEK 36 WEEK 48 WEEK 72 WEEK 96 78% 80% 82% 78% 80% 78% 78% 78% 84% 66% 80% 66% Historical M184V/I
No Historical M184V/I Viral Load TND was defined as a VL <20c/mL BASELINE 78% 80% Blick et al. IAS 2024, #SSOAX0903LB 64% 68% WEEK 144 Viral Load TND was similar across treatment arms<br>
80
60
40
20
0 Patients (%) WEEK 12 WEEK 24 WEEK 36 WEEK 48 WEEK 72 WEEK 96 78% 80% 82% 78% 80% 78% 78% 78% 84% 66% 80% 66% Historical M184V/I
No Historical M184V/I Viral Load TND was defined as a VL <20c/mL BASELINE 78% 80% Blick et al. IAS 2024, #SSOAX0903LB 64% 68% WEEK 144 Viral Load TND was similar across treatment arms<br>
18
18 ADVERSE EVENTS: Through Week 144 Blick et al. IAS 2024, #SSOAX0903LB<br>
19
CONCLUSION SOLAR-3D is the largest prospective, comparative trial with longest follow-up to-date to demonstrate that neither prior/current M184V/I nor multiple prior VFs impact the efficacy and durability of switching virologically suppressed PLWHA to DTG/3TC through 144-weeks. 19 Blick et al. IAS 2024, #SSOAX0903LB<br>
20
LAST THOUGHT 20 Blick et al. IAS 2024, #SSOAX0903LB Switching to STR DTG/3TC must be explored in economically-developing countries in individuals with M184V/I and/or K65R, without DTG-associated RAMs, where economic/safety advantages of discontinuing TDF could be consequential<br>
21
ACKNOWLEDGEMENTS (1) 21 Blick et al. IAS 2024, #SSOAX0903LB In Loving Memory of
Mark Wainberg, PhD
Past President, International AIDS Society (1998-2000),
Internationally Renown HIV/AIDS Researcher, HIV Activist, Global Health, Public Health, Health Promotion & Advocacy, Patient Care, Infectious Disease, Allergy & Immunity, Mentor and Friend Born: April 21, 1945 Died: April 11, 2017 First to identify the antiviral capabilities of 3TC in 1989 and test the drug in patients
Advocate of the impaired viral fitness (VRC) of 3TC-resistant HIV in the setting of M184V/I
“Resistance to 3TC is not really resistance at all”
“3TC can be the key component to a successful 2-drug therapy, even in the presence of M184V/I”<br>
Mark Wainberg, PhD
Past President, International AIDS Society (1998-2000),
Internationally Renown HIV/AIDS Researcher, HIV Activist, Global Health, Public Health, Health Promotion & Advocacy, Patient Care, Infectious Disease, Allergy & Immunity, Mentor and Friend Born: April 21, 1945 Died: April 11, 2017 First to identify the antiviral capabilities of 3TC in 1989 and test the drug in patients
Advocate of the impaired viral fitness (VRC) of 3TC-resistant HIV in the setting of M184V/I
“Resistance to 3TC is not really resistance at all”
“3TC can be the key component to a successful 2-drug therapy, even in the presence of M184V/I”<br>
22
ACKNOWLEDGEMENTS (2) To all of our devoted HIV/AIDS patients who consented to take the unknown risk presented by SOLAR-3D design to further our knowledge base in off-label suppressed switch to DTG/3TC
To Health Care Advocates International, LLC for funding SOLAR-3D and investigators and staff for helping to close this research gap
To Lei Fang of Pharstat for his statistical prowess
To Hubby for his assistance and for tolerating 4 years of my OCD conducting SOLAR-3D Blick et al. IAS 2024, #SSOAX0903LB<br>
To Health Care Advocates International, LLC for funding SOLAR-3D and investigators and staff for helping to close this research gap
To Lei Fang of Pharstat for his statistical prowess
To Hubby for his assistance and for tolerating 4 years of my OCD conducting SOLAR-3D Blick et al. IAS 2024, #SSOAX0903LB<br>