ABSTRACT
Background: Single-tablet tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) has been rapidly adopted as 1st-line ART for patients initiating treatment and switching from virally-suppressive NNRTI-based 1st regimens in PEPFAR programs. There are limited data, however, on effectiveness and emergence of resistance to TLD in programmatic settings where plasma HIV-1 RNA and drug resistance testing are not used widely. Methods: A prospective observational study is being performed at 13 ACTG sites in six countries (Haiti, Kenya, Malawi, South Africa, Uganda, Zimbabwe) coincident with TLD rollout to assess efficacy and emergence of HIV drug resistance following TLD for 1st, 2nd or 3rd-line ART. This report focuses on the 2 Groups that completed enrollment and 6 months of follow-up: Group 1b (Gp1b) participants on NNRTI-based ART for at least 6 months with HIV-1 RNA ≤1000 cps/mL before switch to TLD;and Group 4 (Gp4) ART-naïve participants initiating 1st-line TLD. The primary objective was to estimate the proportions of participants on TLD with HIV-1 RNA ≤1000 cps/mL and with new DTG resistance mutations at 6 months. Results:\From 10/2019-10/2020, we enrolled 600 participants who started TLD: 421 in Gp1b (median age 41years;80% female) and 179 in Gp4 (median age 35years;42% female). In Gp1b, median time on ART was 6.6y (IQR 3.3-10.3);88% were taking EFV with 3TC+TDF or FTC+TDF. In Gp4, median baseline HIV-1 RNA was 4.4 log10 cps/mL (IQR 3.5-5.1). Six participants in Gp1b (1.4%) and 6 in Gp4 (3.4%) discontinued TLD by 6 months, due to withdrawal or loss to follow-up (6 participants), adverse events considered related to TLD (4), and death (2;both Gp4;1 from TB, 1 unknown cause). Among participants followed on TLD to 6 months, 90% in Gp1b (373/415) and 86% in Gp4 (149/173) had a 6-month HIV-1 RNA result (missing values mainly due to COVID-related virtual visits). HIV-1 RNA ≤1000, <200 and <50 cps/mL was achieved in 99%, 98.4%, and 96% of participants in Gp1b and in 90%, 87.2%, and in 84.6% of Gp4, respectively (Table). A new mutation possibly selected by DTG was observed in 1 participant in Gp1b (T97AT) and none in Gp4. Conclusion: TLD was well tolerated and achieved excellent viral suppression in ART-naïve participants and in participants who switched from virally-suppressive 1st-line ART. An emerging InSTI mutation of uncertain significance was seen in only one participant. These data support early tolerability and efficacy of TLD transition in the public sector.
ABSTRACT
The COVID-19 pandemic reached the African continent in less than three months from when the first caseswere reported from mainland China. As COVID-19 preparedness and response plans were rapidly instituted across sub-Saharan Africa, many governments and donor organizations braced themselves for the unknown impact the COVID-19 pandemicwould have in under-resourced settings with high burdens of PLHIV. The potential negative impact of COVID-19 inthese countries is uncertain, but is estimated to contribute both directly and indirectly to the morbidity and mortality ofPLHIV, requiring countries to leverage existing HIV care systems to propel COVID-19 responses, while safeguarding PLHIVand HIV programme gains. In anticipation of COVID-19-related disruptions, PEPFAR promptly established guidance to rapidlyadapt HIV programmes to maintain essential HIV services while protecting recipients of care and staff from COVID-19. Thiscommentary reviews PEPFARs COVID-19 technical guidance and provides country-specific examples of programme adaptionsin sub-Saharan Africa.
ABSTRACT
Background: In sub-Saharan Africa (SSA), the COVID-19 pandemic and response has posed a challenge for HIV prevention, testing, and treatment. We used routinely collected President's Emergency Plan for AIDS Relief (PEPFAR) Monitoring, Evaluation, and Reporting (MER) data to assess potential loss to follow-up (LTFU) across PEPFAR countries in SSA before and during the pandemic to determine the impact of COVID-19 on HIV clinical treatment. Methods: Treatment and LTFU data for people living with HIV (PLHIV) aged 15+ from Oct - Dec 2019 (fiscal year[FY]20 quarter[Q]1;pre-COVID) and Apr - Jun 2020 (FY20Q3;during COVID-19) were extracted from two MER indicators: TX-CURR (PLHIV on treatment) and TX-ML (tracking outcomes of PLHIV potentially LTFU) for 18 countries in SSA. Aggregate indicator data are not linked. Data were disaggregated by age band (15-19, 20-29, 30-39, 40-49, 50+) and sex. Proportions of potential LTFU were calculated as total number of PLHIV with no known clinical contact since last expected contact divided by total PLHIV on treatment during the reporting quarter. Proportions of select outcomes of potential LTFU (Died, LTFU <3 months since last expected clinical contact, LTFU ≥3 months since last expected clinical contact) were calculated as total individual outcome divided by total LTFU. Analyses were disaggregated by reporting quarter, age band, and sex and paired t-tests were run to test for statistical significance between quarters. Results: Number of PLHIV LTFU was 644,380 in FY20Q1 and 740,112 in FY20Q3 across the 18 countries. Proportion of any LTFU outcome was 4.9% and 5.3% for the two quarters, respectively, and was higher overall among men and those aged 20-29, although not statistically significant (Table). Among all LTFU, an increase in deaths and in LTFU ≥3 months among men and a decrease in LTFU <3 months among women and all age bands were statistically significant. Conclusion: The proportion of LTFU <3 months decreased during the early months of the COVID-19 pandemic in SSA, which, in part, may be attributed to adaptations in HIV programming implemented to mitigate further transmission of COVID-19. These data give an initial indication that the COVID-19 pandemic may have implications for HIV treatment in the coming months and ongoing data review is critical.